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The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen

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ClinicalTrials.gov Identifier: NCT00999466
Recruitment Status : Completed
First Posted : October 21, 2009
Results First Posted : January 26, 2016
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Allergic Asthma
Interventions Drug: AZD8848
Drug: Placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part. AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part. Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Period Title: Pilot Part
Started 6 0 [1] 3
Completed 6 0 3
Not Completed 0 0 0
[1]
AZD8848 nasal spray 60 μg group was not participated in the Pilot part
Period Title: Main Part
Started 0 [1] 26 25
Completed 0 22 21
Not Completed 0 4 4
Reason Not Completed
Withdrawal by Subject             0             0             2
Adverse Event             0             4             2
[1]
AZD8848 nasal spray 30 μg group was not participated in the Main part
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo Total
Hide Arm/Group Description AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part. AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part. Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly. Total of all reporting groups
Overall Number of Baseline Participants 6 26 28 60
Hide Baseline Analysis Population Description
AZD8848 30 μg nasal spray was only done in Pilot part. 3 of the 28 placebo subjects were from the PILOT part and 25 placebo subjects were from the MAIN part.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 26 participants 28 participants 60 participants
36.3
(23 to 47)
33.0
(19 to 51)
32.3
(21 to 50)
33.9
(19 to 51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 26 participants 28 participants 60 participants
Female
0
   0.0%
7
  26.9%
7
  25.0%
14
  23.3%
Male
6
 100.0%
19
  73.1%
21
  75.0%
46
  76.7%
1.Primary Outcome
Title FEV1, Late Asthmatic Response (LAR) – Pre-treatment
Hide Description Forced Expiratory Volume in 1 second (FEV1), Late Asthmatic Response (LAR), is derived as the ratio of FEV1 Area Under Curve 4-10 hour post allergen challenge (AUC 4-10h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Time Frame Pre-treatment (Baseline measurement)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 22 23
Mean (Standard Deviation)
Unit of Measure: ratio
0.814  (0.450) 1.01  (0.784)
2.Primary Outcome
Title FEV1, Late Asthmatic Response (LAR) – 1 Week After Last Dose
Hide Description FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Time Frame 1 week after last dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 22 23
Mean (Standard Deviation)
Unit of Measure: ratio
0.616  (0.296) 0.970  (0.641)
3.Primary Outcome
Title FEV1, Late Asthmatic Response (LAR) – 4 Weeks After Last Dose
Hide Description FEV1, Late Asthmatic Response (LAR), is derived as the ratio of FEV1 AUC 4-10h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Time Frame 4 weeks after last dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 22 21
Mean (Standard Deviation)
Unit of Measure: ratio
0.759  (0.397) 0.722  (0.584)
4.Secondary Outcome
Title FEV1, Early Asthmatic Response (EAR) – Pre-treatment
Hide Description FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 Area Under Curve 0-2 hour post allergen challenge (AUC 0-2h) (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Time Frame Pre-treatment (Baseline measurement)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 22 23
Mean (Standard Deviation)
Unit of Measure: ratio
0.524  (0.241) 0.611  (0.362)
5.Secondary Outcome
Title FEV1, Early Asthmatic Response (EAR) – 1 Week After Last Dose
Hide Description FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Time Frame 1 week after last dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 22 23
Mean (Standard Deviation)
Unit of Measure: ratio
0.468  (0.361) 0.624  (0.362)
6.Secondary Outcome
Title FEV1, Early Asthmatic Response (EAR) – 4 Weeks After Last Dose
Hide Description FEV1, Early Asthmatic Response (EAR), is derived as the ratio of FEV1 AUC 0-2h (computed using the trapezoidal formula divided by time) and the pre-challenge FEV1 measurement.
Time Frame 4 weeks after last dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 22 21
Mean (Standard Deviation)
Unit of Measure: ratio
0.510  (0.240) 0.591  (0.401)
7.Secondary Outcome
Title PC20 Methacholine Challenge – Pre-treatment, Pre Allergen Challenge
Hide Description PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 22 23
Geometric Mean (Full Range)
Unit of Measure: mg/mL
0.564
(0.004 to 11.1)
0.609
(0.063 to 5.69)
8.Secondary Outcome
Title PC20 Methacholine Challenge – Pre-treatment, Post Allergen Challenge
Hide Description PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 22 23
Geometric Mean (Full Range)
Unit of Measure: mg/mL
0.425
(0.123 to 6.25)
0.364
(0.063 to 10.2)
9.Secondary Outcome
Title PC20 Methacholine Challenge – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 22 21
Geometric Mean (Full Range)
Unit of Measure: mg/mL
0.488
(0.063 to 3.01)
0.454
(0.063 to 8.25)
10.Secondary Outcome
Title PC20 Methacholine Challenge – 1 Week After Last Dose, Post Allergen Challenge
Hide Description PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 21 21
Geometric Mean (Full Range)
Unit of Measure: mg/mL
0.691
(0.063 to 9.13)
0.340
(0.063 to 17.8)
11.Secondary Outcome
Title PC20 Methacholine Challenge – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 22 21
Geometric Mean (Full Range)
Unit of Measure: mg/mL
0.468
(0.063 to 2.47)
0.504
(0.072 to 4.00)
12.Secondary Outcome
Title PC20 Methacholine Challenge – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description PC20 is the provocation concentration of Methacholine causing a 20% fall in FEV1
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 21 20
Geometric Mean (Full Range)
Unit of Measure: mg/mL
0.326
(0.082 to 4.08)
0.508
(0.063 to 29.1)
13.Secondary Outcome
Title Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
8.9
(3.5 to 25)
4.8
(0.90 to 24)
14.Secondary Outcome
Title Sputum Cellularity and Cytokines, TNFα – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
13
(2.8 to 156)
12
(5.3 to 38)
15.Secondary Outcome
Title Sputum Cellularity and Cytokines, TNFα – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
6.5
(1.7 to 46)
5.3
(0.90 to 23)
16.Secondary Outcome
Title Sputum Cellularity and Cytokines, TNFα – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
11
(2.4 to 539)
8.4
(1.1 to 41)
17.Secondary Outcome
Title Sputum Cellularity and Cytokines, TNFα – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
5.1
(0.90 to 113)
9.4
(1.5 to 510)
18.Secondary Outcome
Title Sputum Cellularity and Cytokines, TNFα – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: pg/mL
13
(4.3 to 125)
7.9
(4.4 to 23)
19.Secondary Outcome
Title Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
37
(6.5 to 127)
23
(0.80 to 243)
20.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-1β – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
41
(13 to 322)
44
(13 to 320)
21.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-1β – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
37
(7.8 to 614)
36
(4.5 to 139)
22.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-1β – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
45
(7.0 to 293)
37
(13 to 217)
23.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-1β – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
29
(6.6 to 303)
43
(7.6 to 366)
24.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-1β – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: pg/mL
72
(15 to 198)
41
(15 to 224)
25.Secondary Outcome
Title Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
0.83
(0.40 to 9.0)
0.87
(0.40 to 5.6)
26.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-5 – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
7.1
(0.40 to 74)
5.8
(0.40 to 27)
27.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-5 – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
0.82
(0.40 to 4.5)
1.3
(0.40 to 11)
28.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-5 – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
7.8
(1.1 to 38)
5.4
(0.90 to 35)
29.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-5 – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
1.2
(0.40 to 5.5)
1.7
(0.40 to 24)
30.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-5 – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: pg/mL
5.7
(0.80 to 38)
8.0
(2.1 to 47)
31.Secondary Outcome
Title Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
15
(4.4 to 61)
9.4
(0.40 to 189)
32.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-6 – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
28
(5.7 to 252)
27
(1.7 to 75)
33.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-6 – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
15
(2.4 to 43)
9.6
(0.40 to 37)
34.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-6 – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
26
(5.2 to 142)
23
(3.1 to 76)
35.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-6 – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
12
(0.60 to 123)
21
(6.3 to 1317)
36.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-6 – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: pg/mL
20
(5.3 to 174)
29
(10 to 107)
37.Secondary Outcome
Title Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
766
(138 to 1784)
522
(8.5 to 2500)
38.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-8 – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
1300
(422 to 2500)
1450
(549 to 2500)
39.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-8 – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
720
(186 to 2500)
609
(63 to 2366)
40.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-8 – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
1272
(284 to 2500)
1270
(240 to 2500)
41.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-8 – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
496
(68 to 2500)
1012
(176 to 2500)
42.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-8 – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: pg/mL
1500
(783 to 2500)
1304
(595 to 2500)
43.Secondary Outcome
Title Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
0.57
(0.50 to 1.1)
0.63
(0.50 to 2.6)
44.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-10 – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
0.86
(0.50 to 32)
0.68
(0.50 to 1.7)
45.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-10 – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
0.60
(0.50 to 2.5)
0.75
(0.50 to 34)
46.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-10 – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
0.79
(0.50 to 53)
0.82
(0.50 to 3.0)
47.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-10 – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
0.54
(0.50 to 0.90)
0.95
(0.50 to 17)
48.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-10 – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: pg/mL
0.68
(0.50 to 1.9)
0.67
(0.50 to 5.7)
49.Secondary Outcome
Title Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
1.3
(1.2 to 3.6)
1.4
(1.2 to 3.8)
50.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-13 – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
3.0
(1.2 to 25)
3.1
(1.2 to 9.2)
51.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-13 – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: pg/mL
1.3
(1.2 to 1.9)
1.8
(1.2 to 8.0)
52.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-13 – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
3.0
(1.2 to 8.3)
2.8
(1.2 to 20)
53.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-13 – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 17
Geometric Mean (Full Range)
Unit of Measure: pg/mL
1.3
(1.2 to 2.1)
1.6
(1.2 to 6.5)
54.Secondary Outcome
Title Sputum Cellularity and Cytokines, IL-13 – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: pg/mL
2.5
(1.2 to 11)
3.1
(1.2 to 17)
55.Secondary Outcome
Title Sputum Cellularity and Cytokines, Total Cells/g – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: Cell count/g
2.7
(1.3 to 6.8)
2.7
(0.67 to 14)
56.Secondary Outcome
Title Sputum Cellularity and Cytokines, Total Cells/g – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: Cell count/g
5.0
(1.1 to 35)
3.5
(0.25 to 7.9)
57.Secondary Outcome
Title Sputum Cellularity and Cytokines, Total Cells/g – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: Cell count/g
3.7
(0.84 to 16)
3.0
(0.95 to 20)
58.Secondary Outcome
Title Sputum Cellularity and Cytokines, Total Cells/g – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: Cell count/g
5.0
(1.9 to 19)
4.2
(0.55 to 18)
59.Secondary Outcome
Title Sputum Cellularity and Cytokines, Total Cells/g – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 16
Geometric Mean (Full Range)
Unit of Measure: Cell count/g
1.9
(0.29 to 9.4)
2.6
(0.58 to 12)
60.Secondary Outcome
Title Sputum Cellularity and Cytokines, Total Cells/g – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: Cell count/g
5.2
(2.2 to 15)
4.0
(1.2 to 12)
61.Secondary Outcome
Title Sputum Cellularity and Cytokines, Eosinophils – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.13
(0.015 to 0.46)
0.12
(0.008 to 3.7)
62.Secondary Outcome
Title Sputum Cellularity and Cytokines, Eosinophils – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.64
(0.008 to 6.5)
0.81
(0.023 to 3.0)
63.Secondary Outcome
Title Sputum Cellularity and Cytokines, Eosinophils – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.18
(0.033 to 2.1)
0.23
(0.008 to 2.8)
64.Secondary Outcome
Title Sputum Cellularity and Cytokines, Eosinophils – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.94
(0.12 to 3.8)
0.82
(0.066 to 6.0)
65.Secondary Outcome
Title Sputum Cellularity and Cytokines, Eosinophils – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 16
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.13
(0.009 to 2.2)
0.21
(0.032 to 1.1)
66.Secondary Outcome
Title Sputum Cellularity and Cytokines, Eosinophils – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
1.0
(0.20 to 5.8)
0.96
(0.13 to 4.6)
67.Secondary Outcome
Title Sputum Cellularity and Cytokines, Neutrophils – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.75
(0.026 to 4.2)
0.93
(0.026 to 10)
68.Secondary Outcome
Title Sputum Cellularity and Cytokines, Neutrophils – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
1.9
(0.45 to 25)
1.5
(0.061 to 4.1)
69.Secondary Outcome
Title Sputum Cellularity and Cytokines, Neutrophils – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
1.5
(0.065 to 15)
0.91
(0.026 to 17)
70.Secondary Outcome
Title Sputum Cellularity and Cytokines, Neutrophils – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
2.1
(0.36 to 9.1)
1.7
(0.22 to 15)
71.Secondary Outcome
Title Sputum Cellularity and Cytokines, Neutrophils – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 16
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.80
(0.097 to 7.5)
1.3
(0.072 to 9.3)
72.Secondary Outcome
Title Sputum Cellularity and Cytokines, Neutrophils – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
2.6
(0.81 to 11)
1.6
(0.40 to 7.8)
73.Secondary Outcome
Title Sputum Cellularity and Cytokines, Macrophages – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
1.1
(0.29 to 2.2)
0.59
(0.004 to 3.7)
74.Secondary Outcome
Title Sputum Cellularity and Cytokines, Macrophages – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
1.1
(0.13 to 4.9)
0.60
(0.10 to 2.1)
75.Secondary Outcome
Title Sputum Cellularity and Cytokines, Macrophages – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.80
(0.088 to 3.1)
0.36
(0.004 to 2.4)
76.Secondary Outcome
Title Sputum Cellularity and Cytokines, Macrophages – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
1.0
(0.20 to 5.2)
0.77
(0.12 to 3.0)
77.Secondary Outcome
Title Sputum Cellularity and Cytokines, Macrophages – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 16
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.47
(0.004 to 1.9)
0.58
(0.22 to 1.6)
78.Secondary Outcome
Title Sputum Cellularity and Cytokines, Macrophages – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.56
(0.087 to 1.8)
0.74
(0.083 to 4.0)
79.Secondary Outcome
Title Sputum Cellularity and Cytokines, Lymphocytes – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.004
(0.002 to 0.027)
0.004
(0.002 to 0.059)
80.Secondary Outcome
Title Sputum Cellularity and Cytokines, Lymphocytes – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.008
(0.002 to 0.086)
0.004
(0.002 to 0.060)
81.Secondary Outcome
Title Sputum Cellularity and Cytokines, Lymphocytes – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.002
(0.002 to 0.016)
0.003
(0.002 to 0.046)
82.Secondary Outcome
Title Sputum Cellularity and Cytokines, Lymphocytes – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.003
(0.002 to 0.040)
0.003
(0.002 to 0.045)
83.Secondary Outcome
Title Sputum Cellularity and Cytokines, Lymphocytes – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 16
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.005
(0.002 to 0.035)
0.005
(0.002 to 0.036)
84.Secondary Outcome
Title Sputum Cellularity and Cytokines, Lymphocytes – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.005
(0.002 to 0.049)
0.003
(0.002 to 0.012)
85.Secondary Outcome
Title Sputum Cellularity and Cytokines, Epithelial Cells – Pre-treatment, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 12 19
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.045
(0.001 to 0.29)
0.053
(0.001 to 0.59)
86.Secondary Outcome
Title Sputum Cellularity and Cytokines, Epithelial Cells – Pre-treatment, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame Pre-treatment, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.078
(0.001 to 3.5)
0.073
(0.001 to 0.35)
87.Secondary Outcome
Title Sputum Cellularity and Cytokines, Epithelial Cells – 1 Week After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 19
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.11
(0.008 to 0.39)
0.045
(0.001 to 1.4)
88.Secondary Outcome
Title Sputum Cellularity and Cytokines, Epithelial Cells – 1 Week After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 1 week after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 17 17
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.067
(0.001 to 0.56)
0.071
(0.001 to 0.47)
89.Secondary Outcome
Title Sputum Cellularity and Cytokines, Epithelial Cells – 4 Weeks After Last Dose, Pre Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, pre allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 16 16
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.045
(0.005 to 0.20)
0.054
(0.001 to 0.43)
90.Secondary Outcome
Title Sputum Cellularity and Cytokines, Epithelial Cells – 4 Weeks After Last Dose, Post Allergen Challenge
Hide Description [Not Specified]
Time Frame 4 weeks after last dose, post allergen challenge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There were 6 AZD8848 nasal spray 30 μg subjects and 3 placebo subjects participated in the Pilot part only that they did not have outcome measure collected. The number of participants analyzed for each outcome measure were subset of the subjects who participated in the Main part and also provided data for that measure.
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description:
AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Overall Number of Participants Analyzed 0 13 16
Geometric Mean (Full Range)
Unit of Measure: 10^6 cells/g
0.037
(0.001 to 0.17)
0.082
(0.018 to 0.24)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD8848, 30 μg AZD8848, 60 μg Placebo
Hide Arm/Group Description AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part. AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part. Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
All-Cause Mortality
AZD8848, 30 μg AZD8848, 60 μg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZD8848, 30 μg AZD8848, 60 μg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0   0   1 
Infections and infestations       
Tonsillitis Bacterial  1  0/6 (0.00%)  0/26 (0.00%)  1/28 (3.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD8848, 30 μg AZD8848, 60 μg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6   22   24 
Ear and labyrinth disorders       
TINNITUS  1  1/6 (16.67%)  0/26 (0.00%)  1/28 (3.57%) 
Eye disorders       
Eye Pruritus  1  0/6 (0.00%)  0/26 (0.00%)  2/28 (7.14%) 
LACRIMATION INCREASED  1  0/6 (0.00%)  0/26 (0.00%)  2/28 (7.14%) 
EYE SWELLING  1  1/6 (16.67%)  0/26 (0.00%)  0/28 (0.00%) 
Gastrointestinal disorders       
Dysphagia  1  1/6 (16.67%)  0/26 (0.00%)  0/28 (0.00%) 
GLOSSODYNIA  1  1/6 (16.67%)  0/26 (0.00%)  0/28 (0.00%) 
SWOLLEN TONGUE  1  1/6 (16.67%)  0/26 (0.00%)  0/28 (0.00%) 
General disorders       
Pain  1  0/6 (0.00%)  1/26 (3.85%)  2/28 (7.14%) 
CHEST DISCOMFORT  1  0/6 (0.00%)  2/26 (7.69%)  2/28 (7.14%) 
PYREXIA  1  2/6 (33.33%)  4/26 (15.38%)  2/28 (7.14%) 
Immune system disorders       
ALLERGY TO ARTHROPOD BITE  1  0/6 (0.00%)  2/26 (7.69%)  0/28 (0.00%) 
Infections and infestations       
NASAL VESTIBULITIS  1  1/6 (16.67%)  0/26 (0.00%)  0/28 (0.00%) 
RHINITIS  1  0/6 (0.00%)  2/26 (7.69%)  5/28 (17.86%) 
NASOPHARYNGITIS  1  1/6 (16.67%)  2/26 (7.69%)  4/28 (14.29%) 
Injury, poisoning and procedural complications       
FACE INJURY  1  1/6 (16.67%)  0/26 (0.00%)  0/28 (0.00%) 
Musculoskeletal and connective tissue disorders       
PAIN IN EXTREMITY  1  1/6 (16.67%)  0/26 (0.00%)  0/28 (0.00%) 
BACK PAIN  1  1/6 (16.67%)  1/26 (3.85%)  0/28 (0.00%) 
ARTHRALGIA  1  1/6 (16.67%)  3/26 (11.54%)  1/28 (3.57%) 
Nervous system disorders