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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00999466
First received: October 20, 2009
Last updated: January 28, 2016
Last verified: January 2016
Results First Received: August 31, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Allergic Asthma
Interventions: Drug: AZD8848
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AZD8848, 30 μg AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848, 60 μg AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.

Participant Flow for 2 periods

Period 1:   Pilot Part
    AZD8848, 30 μg     AZD8848, 60 μg     Placebo  
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 2:   Main Part
    AZD8848, 30 μg     AZD8848, 60 μg     Placebo  
STARTED     0 [1]   26     25  
COMPLETED     0     22     21  
NOT COMPLETED     0     4     4  
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
AZD8848, 30 μg AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
AZD8848, 60 μg AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
Placebo Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
Total Total of all reporting groups

Baseline Measures
    AZD8848, 30 μg     AZD8848, 60 μg     Placebo     Total  
Number of Participants  
[units: participants]
  6     26     28     60  
Age  
[units: Years]
Mean (Full Range)
  36.3  
  (23 to 47)  
  33.0  
  (19 to 51)  
  32.3  
  (21 to 50)  
  33.9  
  (19 to 51)  
Gender  
[units: Participants]
       
Female     0     7     7     14  
Male     6     19     21     46  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   FEV1, Late Asthmatic Response (LAR) – Pre-treatment   [ Time Frame: Pre-treatment (Baseline measurement) ]

2.  Primary:   FEV1, Late Asthmatic Response (LAR) – 1 Week After Last Dose   [ Time Frame: 1 week after last dose ]

3.  Primary:   FEV1, Late Asthmatic Response (LAR) – 4 Weeks After Last Dose   [ Time Frame: 4 weeks after last dose ]

4.  Secondary:   FEV1, Early Asthmatic Response (EAR) – Pre-treatment   [ Time Frame: Pre-treatment (Baseline measurement) ]

5.  Secondary:   FEV1, Early Asthmatic Response (EAR) – 1 Week After Last Dose   [ Time Frame: 1 week after last dose ]

6.  Secondary:   FEV1, Early Asthmatic Response (EAR) – 4 Weeks After Last Dose   [ Time Frame: 4 weeks after last dose ]

7.  Secondary:   PC20 Methacholine Challenge – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

8.  Secondary:   PC20 Methacholine Challenge – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

9.  Secondary:   PC20 Methacholine Challenge – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

10.  Secondary:   PC20 Methacholine Challenge – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

11.  Secondary:   PC20 Methacholine Challenge – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

12.  Secondary:   PC20 Methacholine Challenge – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

13.  Secondary:   Sputum Cellularity and Cytokines, Tumour Necrosis Factor Alpha (TNFα) – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

14.  Secondary:   Sputum Cellularity and Cytokines, TNFα – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

15.  Secondary:   Sputum Cellularity and Cytokines, TNFα – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

16.  Secondary:   Sputum Cellularity and Cytokines, TNFα – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

17.  Secondary:   Sputum Cellularity and Cytokines, TNFα – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

18.  Secondary:   Sputum Cellularity and Cytokines, TNFα – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

19.  Secondary:   Sputum Cellularity and Cytokines, Interleukin-1β (IL-1β) – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

20.  Secondary:   Sputum Cellularity and Cytokines, IL-1β – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

21.  Secondary:   Sputum Cellularity and Cytokines, IL-1β – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

22.  Secondary:   Sputum Cellularity and Cytokines, IL-1β – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

23.  Secondary:   Sputum Cellularity and Cytokines, IL-1β – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

24.  Secondary:   Sputum Cellularity and Cytokines, IL-1β – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

25.  Secondary:   Sputum Cellularity and Cytokines, Interleukin-5 (IL-5) – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

26.  Secondary:   Sputum Cellularity and Cytokines, IL-5 – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

27.  Secondary:   Sputum Cellularity and Cytokines, IL-5 – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

28.  Secondary:   Sputum Cellularity and Cytokines, IL-5 – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

29.  Secondary:   Sputum Cellularity and Cytokines, IL-5 – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

30.  Secondary:   Sputum Cellularity and Cytokines, IL-5 – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

31.  Secondary:   Sputum Cellularity and Cytokines, Interleukin-6 (IL-6) – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

32.  Secondary:   Sputum Cellularity and Cytokines, IL-6 – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

33.  Secondary:   Sputum Cellularity and Cytokines, IL-6 – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

34.  Secondary:   Sputum Cellularity and Cytokines, IL-6 – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

35.  Secondary:   Sputum Cellularity and Cytokines, IL-6 – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

36.  Secondary:   Sputum Cellularity and Cytokines, IL-6 – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

37.  Secondary:   Sputum Cellularity and Cytokines, Interleukin-8 (IL-8) – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

38.  Secondary:   Sputum Cellularity and Cytokines, IL-8 – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

39.  Secondary:   Sputum Cellularity and Cytokines, IL-8 – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

40.  Secondary:   Sputum Cellularity and Cytokines, IL-8 – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

41.  Secondary:   Sputum Cellularity and Cytokines, IL-8 – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

42.  Secondary:   Sputum Cellularity and Cytokines, IL-8 – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

43.  Secondary:   Sputum Cellularity and Cytokines, Interleukin-10 (IL-10) – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

44.  Secondary:   Sputum Cellularity and Cytokines, IL-10 – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

45.  Secondary:   Sputum Cellularity and Cytokines, IL-10 – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

46.  Secondary:   Sputum Cellularity and Cytokines, IL-10 – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

47.  Secondary:   Sputum Cellularity and Cytokines, IL-10 – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

48.  Secondary:   Sputum Cellularity and Cytokines, IL-10 – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

49.  Secondary:   Sputum Cellularity and Cytokines, Interleukin-13 (IL-13) – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

50.  Secondary:   Sputum Cellularity and Cytokines, IL-13 – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

51.  Secondary:   Sputum Cellularity and Cytokines, IL-13 – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

52.  Secondary:   Sputum Cellularity and Cytokines, IL-13 – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

53.  Secondary:   Sputum Cellularity and Cytokines, IL-13 – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

54.  Secondary:   Sputum Cellularity and Cytokines, IL-13 – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

55.  Secondary:   Sputum Cellularity and Cytokines, Total Cells/g – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

56.  Secondary:   Sputum Cellularity and Cytokines, Total Cells/g – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

57.  Secondary:   Sputum Cellularity and Cytokines, Total Cells/g – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

58.  Secondary:   Sputum Cellularity and Cytokines, Total Cells/g – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

59.  Secondary:   Sputum Cellularity and Cytokines, Total Cells/g – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

60.  Secondary:   Sputum Cellularity and Cytokines, Total Cells/g – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

61.  Secondary:   Sputum Cellularity and Cytokines, Eosinophils – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

62.  Secondary:   Sputum Cellularity and Cytokines, Eosinophils – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

63.  Secondary:   Sputum Cellularity and Cytokines, Eosinophils – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

64.  Secondary:   Sputum Cellularity and Cytokines, Eosinophils – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

65.  Secondary:   Sputum Cellularity and Cytokines, Eosinophils – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

66.  Secondary:   Sputum Cellularity and Cytokines, Eosinophils – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

67.  Secondary:   Sputum Cellularity and Cytokines, Neutrophils – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

68.  Secondary:   Sputum Cellularity and Cytokines, Neutrophils – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

69.  Secondary:   Sputum Cellularity and Cytokines, Neutrophils – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

70.  Secondary:   Sputum Cellularity and Cytokines, Neutrophils – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

71.  Secondary:   Sputum Cellularity and Cytokines, Neutrophils – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

72.  Secondary:   Sputum Cellularity and Cytokines, Neutrophils – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

73.  Secondary:   Sputum Cellularity and Cytokines, Macrophages – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

74.  Secondary:   Sputum Cellularity and Cytokines, Macrophages – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

75.  Secondary:   Sputum Cellularity and Cytokines, Macrophages – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

76.  Secondary:   Sputum Cellularity and Cytokines, Macrophages – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

77.  Secondary:   Sputum Cellularity and Cytokines, Macrophages – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

78.  Secondary:   Sputum Cellularity and Cytokines, Macrophages – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

79.  Secondary:   Sputum Cellularity and Cytokines, Lymphocytes – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

80.  Secondary:   Sputum Cellularity and Cytokines, Lymphocytes – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

81.  Secondary:   Sputum Cellularity and Cytokines, Lymphocytes – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

82.  Secondary:   Sputum Cellularity and Cytokines, Lymphocytes – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

83.  Secondary:   Sputum Cellularity and Cytokines, Lymphocytes – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

84.  Secondary:   Sputum Cellularity and Cytokines, Lymphocytes – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]

85.  Secondary:   Sputum Cellularity and Cytokines, Epithelial Cells – Pre-treatment, Pre Allergen Challenge   [ Time Frame: Pre-treatment, pre allergen challenge ]

86.  Secondary:   Sputum Cellularity and Cytokines, Epithelial Cells – Pre-treatment, Post Allergen Challenge   [ Time Frame: Pre-treatment, post allergen challenge ]

87.  Secondary:   Sputum Cellularity and Cytokines, Epithelial Cells – 1 Week After Last Dose, Pre Allergen Challenge   [ Time Frame: 1 week after last dose, pre allergen challenge ]

88.  Secondary:   Sputum Cellularity and Cytokines, Epithelial Cells – 1 Week After Last Dose, Post Allergen Challenge   [ Time Frame: 1 week after last dose, post allergen challenge ]

89.  Secondary:   Sputum Cellularity and Cytokines, Epithelial Cells – 4 Weeks After Last Dose, Pre Allergen Challenge   [ Time Frame: 4 weeks after last dose, pre allergen challenge ]

90.  Secondary:   Sputum Cellularity and Cytokines, Epithelial Cells – 4 Weeks After Last Dose, Post Allergen Challenge   [ Time Frame: 4 weeks after last dose, post allergen challenge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00999466     History of Changes
Other Study ID Numbers: D0540C00004
Study First Received: October 20, 2009
Results First Received: August 31, 2015
Last Updated: January 28, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee