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Trial record 3 of 16 for:    AZD 5069

A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma. (NIMBUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01704495
Recruitment Status : Completed
First Posted : October 11, 2012
Results First Posted : March 1, 2016
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: AZD5069
Drug: Placebo
Enrollment 1147
Recruitment Details 6 months double-blind study with optional safety extension for up to 6 months, were subjects continued on the treatment they were randomized to. First subject enrolled 27 Nov 2012 Last subject last visit 27 Aug 2014 1146 subjects enrolled in tot of which 506 patients were not randomized since they did not fulfilled all the inclusion conditions.
Pre-assignment Details

4 weeks run-in period on background therapy prior to randomization.

The discrepancy in the number of enrolled patients compared to the protocol section (n=1147) is because of a patient was in error reported by a monitor as enrolled when the patient was in effect not enrolled.

Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description AZD5069 oral capsules self-administered twice daily AZD5069 oral capsules self-administered twice daily AZD5069 oral capsules self-administered twice daily Placebo oral capsules self-administred twice daily
Period Title: Subjects Randomized
Started 162 156 160 162
Completed 140 141 144 145
Not Completed 22 15 16 17
Reason Not Completed
Other Reason             3             2             3             2
Discontinuation criteria met             4             2             2             0
Adverse Event             8             2             0             7
Withdrawal by Subject             5             5             5             5
Protocol Violation             1             1             2             0
Eligibility criteria not fulfilled             1             3             4             3
Period Title: Optional Safety Extension
Started 116 [1] 121 [2] 114 [1] 116 [1]
Completed 87 88 83 85
Not Completed 29 33 31 31
Reason Not Completed
Adverse Event             0             4             0             1
Other reason             27             29             30             28
Withdrawal by Subject             2             0             1             2
[1]
46 subjects did not enter safety extension
[2]
35 subjects did not enter safety extension
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo Total
Hide Arm/Group Description AZD5069 oral capsules self-administered twice daily AZD5069 oral capsules self-administered twice daily AZD5069 oral capsules self-administered twice daily Placebo oral capsules self-administred twice daily Total of all reporting groups
Overall Number of Baseline Participants 162 156 160 162 640
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants 156 participants 160 participants 162 participants 640 participants
51  (11.6) 52  (12.7) 53  (11.5) 54  (11.1) 52  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants 156 participants 160 participants 162 participants 640 participants
Female
107
  66.0%
113
  72.4%
104
  65.0%
120
  74.1%
444
  69.4%
Male
55
  34.0%
43
  27.6%
56
  35.0%
42
  25.9%
196
  30.6%
FEV1 pre-bronchodilator  
Median (Full Range)
Unit of measure:  Percentage of predicted normal
Number Analyzed 162 participants 156 participants 160 participants 162 participants 640 participants
63.74
(30.11 to 85.41)
66.35
(29.92 to 113.57)
65.76
(32.57 to 123.86)
61.58
(31.13 to 84.86)
64.93
(29.92 to 123.86)
FEV1 post-bronchodilator  
Median (Full Range)
Unit of measure:  Percentage of predicted normal
Number Analyzed 162 participants 156 participants 160 participants 162 participants 640 participants
74.34
(32.33 to 105.44)
77.95
(30.38 to 112.83)
76.31
(34.88 to 112.89)
72.19
(31.26 to 111.88)
75.22
(30.38 to 112.89)
Reversibility  
Mean (Standard Deviation)
Unit of measure:  Percentage change
Number Analyzed 162 participants 156 participants 160 participants 162 participants 640 participants
18.73  (20.617) 16.05  (15.580) 18.41  (20.574) 18.45  (16.342) 17.93  (18.438)
1.Primary Outcome
Title Rate of Severe Asthma Exacerbations During 6 Months
Hide Description [Not Specified]
Time Frame From start of treatment up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 161 153 156 159
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Exacerbations per 6 month
0.31
(0.20 to 0.50)
0.31
(0.19 to 0.49)
0.26
(0.16 to 0.42)
0.20
(0.12 to 0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AZD5069 45 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments 2-sided p-value
Method Poisson regression
Comments Correction for overdispersion made by Pearson chi-square
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.56
Confidence Interval (2-Sided) 90%
0.98 to 2.49
Estimation Comments AZD5069 45 mg BID vs Placebo
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AZD5069 15 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.141
Comments 2-sided
Method Poisson Regression
Comments Correction for overdispersion made by Pearson chi-square
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.53
Confidence Interval (2-Sided) 90%
0.95 to 2.46
Estimation Comments AZD5069 15 mg BID vs Placebo
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection AZD5069 5 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.397
Comments 2-sided
Method Poisson Regression
Comments Correction for overdispersion made by Pearson chi-square
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.29
Confidence Interval (2-Sided) 90%
0.79 to 2.11
Estimation Comments AZD5069 5 mg BID vs Placebo
2.Secondary Outcome
Title Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months
Hide Description [Not Specified]
Time Frame From start of treatment up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 161 153 156 159
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Exacerbations per 6 month
0.04
(0.01 to 0.14)
0.02
(0.00 to 0.09)
0.02
(0.02 to 0.09)
0.02
(0.01 to 0.09)
3.Secondary Outcome
Title Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions
Hide Description [Not Specified]
Time Frame From start of treatment up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 161 153 156 159
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Days
0.54
(0.26 to 1.12)
0.82
(0.38 to 1.77)
0.00
(0.00 to 0.01)
0.08
(0.03 to 0.23)
4.Secondary Outcome
Title Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms
Hide Description [Not Specified]
Time Frame From start of treatment up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 161 153 156 159
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Days
2.38
(1.33 to 4.26)
2.43
(1.33 to 4.45)
2.74
(1.42 to 5.29)
1.55
(0.80 to 3.00)
5.Secondary Outcome
Title Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1
Hide Description Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis
Time Frame Baseline (Day 0) and 2 weeks after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 155 145 149 155
Least Squares Mean (90% Confidence Interval)
Unit of Measure: L
0.13
(0.06 to 0.20)
0.07
(0.00 to 0.14)
0.09
(0.02 to 0.16)
0.12
(0.05 to 0.19)
6.Secondary Outcome
Title Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1
Hide Description Only patients with both a non-missing value at baseline and visit at one month are included in the analysis
Time Frame Baseline (Day 0) and 1 month after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 153 146 146 153
Least Squares Mean (95% Confidence Interval)
Unit of Measure: L
0.14
(0.07 to 0.21)
0.08
(0.01 to 0.16)
0.09
(0.02 to 0.16)
0.09
(0.02 to 0.16)
7.Secondary Outcome
Title Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1
Hide Description Only patients with both a non-missing value at baseline and visit at two months are included in the analysis
Time Frame Baseline (Day 0) and 2 months after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 150 143 145 150
Least Squares Mean (90% Confidence Interval)
Unit of Measure: L
0.13
(0.06 to 0.20)
0.08
(0.01 to 0.16)
0.07
(-0.01 to 0.14)
0.12
(0.05 to 0.19)
8.Secondary Outcome
Title Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1
Hide Description Only patients with both a non-missing value at baseline and visit at three months are included in the analysis
Time Frame Baseline (Day 0) and 3 months after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 146 142 145 149
Least Squares Mean (90% Confidence Interval)
Unit of Measure: L
0.10
(0.03 to 0.18)
0.11
(0.04 to 0.18)
0.06
(-0.02 to 0.13)
0.06
(-0.01 to 0.13)
9.Secondary Outcome
Title Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1
Hide Description Only patients with both a non-missing value at baseline and visit at four months are included in the analysis
Time Frame Baseline (Day 0) and 4 months after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 148 142 146 148
Least Squares Mean (90% Confidence Interval)
Unit of Measure: L
0.17
(0.09 to 0.24)
0.17
(0.09 to 0.24)
0.14
(0.06 to 0.21)
0.16
(0.08 to 0.23)
10.Secondary Outcome
Title Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1
Hide Description Only patients with both a non-missing value at baseline and visit at six months are included in the analysis
Time Frame Baseline (Day 0) and 6 months after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 144 140 145 149
Least Squares Mean (90% Confidence Interval)
Unit of Measure: L
0.14
(0.06 to 0.21)
0.09
(0.01 to 0.16)
0.10
(0.03 to 0.18)
0.11
(0.04 to 0.18)
11.Secondary Outcome
Title Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1
Hide Description Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis
Time Frame Baseline (Day 0) and 2 weeks after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 146 139 143 146
Least Squares Mean (90% Confidence Interval)
Unit of Measure: L
0.06
(0.01 to 0.11)
0.05
(-0.01 to 0.10)
0.03
(-0.02 to 0.09)
0.03
(-0.02 to 0.09)
12.Secondary Outcome
Title Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1
Hide Description Only patients with both a non-missing value at baseline and visit at one month are included in the analysis
Time Frame Baseline (Day 0) and 1 month after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 144 140 141 142
Least Squares Mean (90% Confidence Interval)
Unit of Measure: L
0.06
(0.01 to 0.12)
0.05
(0.00 to 0.11)
0.03
(-0.03 to 0.09)
0.03
(-0.03 to 0.08)
13.Secondary Outcome
Title Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1
Hide Description Only patients with both a non-missing value at baseline and visit at two months are included in the analysis
Time Frame Baseline (Day 0) and 2 months after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 142 138 141 142
Least Squares Mean (90% Confidence Interval)
Unit of Measure: L
0.03
(-0.02 to 0.09)
0.04
(-0.02 to 0.10)
0.01
(-0.05 to 0.07)
0.02
(-0.04 to 0.08)
14.Secondary Outcome
Title Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1
Hide Description Only patients with both a non-missing value at baseline and visit at three months are included in the analysis
Time Frame Baseline (Day 0) and 3 months after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 138 136 141 143
Least Squares Mean (90% Confidence Interval)
Unit of Measure: L
0.04
(-0.02 to 0.10)
0.04
(-0.02 to 0.10)
-0.00
(-0.06 to 0.06)
-0.01
(-0.07 to 0.05)
15.Secondary Outcome
Title Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1
Hide Description Only patients with both a non-missing value at baseline and visit at four months are included in the analysis
Time Frame Baseline (Day 0) and 4 months after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 141 136 141 141
Least Squares Mean (90% Confidence Interval)
Unit of Measure: L
0.06
(-0.00 to 0.12)
0.06
(0.00 to 0.13)
0.03
(-0.03 to 0.10)
0.03
(-0.03 to 0.10)
16.Secondary Outcome
Title Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1
Hide Description Only patients with both a non-missing value at baseline and visit at six months are included in the analysis
Time Frame Baseline (Day 0) and 6 months after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 139 136 142 145
Least Squares Mean (90% Confidence Interval)
Unit of Measure: L
0.06
(0.01 to 0.12)
0.02
(-0.03 to 0.08)
0.04
(-0.02 to 0.10)
-0.01
(-0.07 to 0.05)
17.Secondary Outcome
Title Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score
Hide Description The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
Time Frame Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 154 149 149 156
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Units on a scale]
-0.68
(-0.83 to -0.52)
-0.66
(-0.82 to -0.51)
-0.64
(-0.80 to -0.48)
-0.70
(-0.86 to -0.55)
18.Secondary Outcome
Title Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)
Hide Description The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
Time Frame Baseline (Day 0) and 6 months after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 133 134 134 141
Measure Type: Number
Unit of Measure: Participants with improvement
72 88 73 69
19.Secondary Outcome
Title Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score
Hide Description The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
Time Frame Baseline (Day 0), Treatment Period (1,3, and 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 152 145 145 153
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Overall Score
0.50
(0.36 to 0.65)
0.46
(0.31 to 0.61)
0.52
(0.37 to 0.67)
0.52
(0.38 to 0.67)
20.Secondary Outcome
Title Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score
Hide Description The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
Time Frame Baseline (Day 0) and 6 months after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 132 132 131 139
Measure Type: Number
Unit of Measure: Participants with improvement
62 68 69 62
21.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 160 153 156 159
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Asthma symptom free days
-0.4
(-3.4 to 2.7)
1.6
(-1.5 to 4.6)
1.2
(-2.0 to 4.3)
1.1
(-1.9 to 4.1)
22.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)
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Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 158 148 152 155
Least Squares Mean (90% Confidence Interval)
Unit of Measure: symptom free days
0.2
(-4.3 to 4.7)
2.6
(-2.0 to 7.1)
3.4
(-1.2 to 8.1)
3.1
(-1.4 to 7.6)
23.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)
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Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 155 146 149 154
Least Squares Mean (90% Confidence Interval)
Unit of Measure: symptom free days
1.4
(-3.4 to 6.3)
4.3
(-0.6 to 9.3)
3.0
(-2.1 to 8.0)
4.0
(-0.9 to 8.9)
24.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)
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Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 152 145 148 151
Least Squares Mean (90% Confidence Interval)
Unit of Measure: symptom free days
2.6
(-2.5 to 7.8)
5.6
(0.5 to 10.7)
3.9
(-1.3 to 9.2)
4.4
(-0.7 to 9.5)
25.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)
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Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 160 153 156 159
Least Squares Mean (90% Confidence Interval)
Unit of Measure: asthma control days
-1.1
(-3.9 to 1.6)
1.7
(-1.1 to 4.6)
1.2
(-1.7 to 4.1)
0.9
(-1.8 to 3.7)
26.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)
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Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 158 148 151 155
Least Squares Mean (90% Confidence Interval)
Unit of Measure: asthma control days
-0.1
(-4.2 to 4.0)
3.5
(-0.7 to 7.7)
2.7
(-4.2 to 4.0)
2.8
(-1.4 to 6.9)
27.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 155 146 149 154
Least Squares Mean (90% Confidence Interval)
Unit of Measure: asthma control days
0.9
(-3.8 to 5.6)
4.7
(-0.0 to 9.4)
3.2
(-1.6 to 8.1)
2.9
(-1.8 to 7.6)
28.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 152 145 148 151
Least Squares Mean (90% Confidence Interval)
Unit of Measure: asthma control days
1.4
(-3.4 to 6.2)
5.7
(0.9 to 10.5)
3.9
(-1.0 to 8.8)
2.4
(-2.3 to 7.2)
29.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)
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Hide Analysis Population Description
Full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 160 153 156 159
Least Squares Mean (90% Confidence Interval)
Unit of Measure: rescue medication free days
4.0
(-0.6 to 8.6)
8.3
(3.6 to 13.0)
6.8
(2.0 to 11.5)
9.5
(4.9 to 14.1)
30.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)
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Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 158 148 150 155
Least Squares Mean (90% Confidence Interval)
Unit of Measure: rescue medication free days
10.7
(4.6 to 16.8)
17.6
(11.4 to 23.8)
15.4
(9.1 to 21.8)
16.4
(10.3 to 22.6)
31.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 155 146 147 153
Least Squares Mean (90% Confidence Interval)
Unit of Measure: rescue medication free days
12.3
(5.7 to 18.9)
19.2
(12.6 to 25.9)
19.8
(13.0 to 26.6)
18.7
(12.1 to 25.3)
32.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 152 145 147 150
Least Squares Mean (90% Confidence Interval)
Unit of Measure: rescue medication free days
15.8
(9.0 to 22.7)
23.1
(16.2 to 29.9)
21.2
(14.2 to 28.2)
20.0
(13.2 to 26.8)
33.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)
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Hide Analysis Population Description
Full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 161 153 156 159
Least Squares Mean (90% Confidence Interval)
Unit of Measure: night time awakenings
-10.1
(-14.6 to -5.5)
-11.1
(-15.7 to -6.5)
-11.3
(-16.0 to -6.6)
-8.9
(-13.4 to -4.3)
34.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)
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Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 158 148 152 156
Least Squares Mean (90% Confidence Interval)
Unit of Measure: night time awakenings
-15.2
(-20.7 to -9.8)
-19.0
(-24.5 to -13.5)
-18.2
(-23.8 to -12.6)
-15.2
(-20.7 to -9.7)
35.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)
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Hide Analysis Population Description
full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 155 146 149 154
Least Squares Mean (90% Confidence Interval)
Unit of Measure: night time awakenings
-17.6
(-23.2 to -11.9)
-19.8
(-25.5 to -14.0)
-22.1
(-27.9 to -16.2)
-16.7
(-22.4 to -11.0)
36.Secondary Outcome
Title Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms
Hide Description [Not Specified]
Time Frame Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 153 145 148 152
Least Squares Mean (90% Confidence Interval)
Unit of Measure: night time awakenings
-22.8
(-28.7 to -17.0)
-25.5
(-31.3 to -19.6)
-25.3
(-31.3 to -19.3)
-21.8
(-27.7 to -16.0)
37.Secondary Outcome
Title Number of Participants With Well Controlled Asthma Weeks at Baseline
Hide Description [Not Specified]
Time Frame Last 2 weeks before randomization
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 160 153 156 159
Measure Type: Number
Unit of Measure: participants
0 Well-controlled asthma weeks Baseline 154 152 150 152
1 Well-controlled asthma weeks Baseline 6 1 4 7
2 Well-controlled asthma weeks Baseline 0 0 2 0
38.Secondary Outcome
Title Number of Well Controlled Asthma Weeks During Treatment
Hide Description [Not Specified]
Time Frame Day 1to end of the 6 months treatment period
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Full Analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 162 156 160 158
Mean (Standard Deviation)
Unit of Measure: well controlled asthma weeks
1.7  (4.38) 1.9  (4.78) 2.4  (5.38) 2.3  (5.27)
39.Secondary Outcome
Title Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline
Hide Description [Not Specified]
Time Frame Last 2 weeks before randomization
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Full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 160 153 156 158
Measure Type: Number
Unit of Measure: participants
0 uncontrolled persistent asthma weeks 23 18 26 27
1 uncontrolled persistent asthma weeks 40 39 34 36
2 uncontrolled persistent asthma weeks 97 96 96 95
40.Secondary Outcome
Title Number of Uncontrolled Persistent Asthma Weeks During Treatment
Hide Description [Not Specified]
Time Frame Day 1 to end of the 6 months treatment period
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Full analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 162 156 160 157
Mean (Standard Deviation)
Unit of Measure: uncontrolled persistent asthma weeks
11.0  (10.0) 10.7  (10.02) 10.4  (9.84) 10.9  (9.89)
41.Secondary Outcome
Title Mean Plasma Concentration of AZD5069 at Day 7
Hide Description [Not Specified]
Time Frame Day 7
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PK analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 159 147 144 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (nmol/L)
235.0
(1525.49%)
69.9
(717.83%)
25.4
(511.02%)
42.Secondary Outcome
Title Mean Plasma Concentration of AZD5069 at 1 Month
Hide Description [Not Specified]
Time Frame at 1 month
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PK analysis set
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description:
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
AZD5069 oral capsules self-administered twice daily
Placebo oral capsules self-administred twice daily
Overall Number of Participants Analyzed 148 135 139 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: (nmol/L)
152.2
(11200.64%)
76.4
(788.17%)
25.8
(449.02%)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Hide Arm/Group Description AZD5069 oral capsules self-administered twice daily AZD5069 oral capsules self-administered twice daily AZD5069 oral capsules self-administered twice daily Placebo oral capsules self-administered twice daily
All-Cause Mortality
AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/161 (8.70%)   8/153 (5.23%)   7/156 (4.49%)   13/159 (8.18%) 
Blood and lymphatic system disorders         
NEUTROPENIA   0/161 (0.00%)  1/153 (0.65%)  0/156 (0.00%)  0/159 (0.00%) 
Cardiac disorders         
ATRIAL FIBRILLATION   1/161 (0.62%)  0/153 (0.00%)  0/156 (0.00%)  2/159 (1.26%) 
CORONARY ARTERY DISEASE   0/161 (0.00%)  0/153 (0.00%)  0/156 (0.00%)  1/159 (0.63%) 
Congenital, familial and genetic disorders         
PSEUDOHYPOPARATHYROIDISM   0/161 (0.00%)  0/153 (0.00%)  1/156 (0.64%)  0/159 (0.00%) 
Gastrointestinal disorders         
BARRETTS OESOPHAGUS   0/161 (0.00%)  1/153 (0.65%)  0/156 (0.00%)  0/159 (0.00%) 
GASTRITIS   1/161 (0.62%)  0/153 (0.00%)  0/156 (0.00%)  0/159 (0.00%) 
HIATUS HERNIA   0/161 (0.00%)  1/153 (0.65%)  0/156 (0.00%)  0/159 (0.00%) 
ABDOMINAL HERNIA   0/161 (0.00%)  0/153 (0.00%)  0/156 (0.00%)  1/159 (0.63%) 
INGUINAL HERNIA   0/161 (0.00%)  0/153 (0.00%)  0/156 (0.00%)  1/159 (0.63%) 
Hepatobiliary disorders         
CHOLECYSTITIS CHRONIC   0/161 (0.00%)  0/153 (0.00%)  1/156 (0.64%)  1/159 (0.63%) 
CHOLELITHIASIS   0/161 (0.00%)  1/153 (0.65%)  0/156 (0.00%)  0/159 (0.00%) 
Infections and infestations         
PNEUMONIA   3/161 (1.86%)  1/153 (0.65%)  0/156 (0.00%)  2/159 (1.26%) 
ABDOMINAL ABSCESS   1/161 (0.62%)  0/153 (0.00%)  0/156 (0.00%)  0/159 (0.00%) 
HELICOBACTER GASTRITIS   0/161 (0.00%)  1/153 (0.65%)  0/156 (0.00%)  0/159 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION   1/161 (0.62%)  0/153 (0.00%)  0/156 (0.00%)  0/159 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION BACTERIAL   0/161 (0.00%)  0/153 (0.00%)  1/156 (0.64%)  0/159 (0.00%) 
SALMONELLOSIS   0/161 (0.00%)  1/153 (0.65%)  0/156 (0.00%)  0/159 (0.00%) 
STREPTOCOCCAL SEPSIS   0/161 (0.00%)  1/153 (0.65%)  0/156 (0.00%)  0/159 (0.00%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION   1/161 (0.62%)  0/153 (0.00%)  0/156 (0.00%)  0/159 (0.00%) 
ACUTE TONSILLITIS   0/161 (0.00%)  0/153 (0.00%)  0/156 (0.00%)  1/159 (0.63%) 
Injury, poisoning and procedural complications         
PATELLA FRACTURE   1/161 (0.62%)  0/153 (0.00%)  0/156 (0.00%)  0/159 (0.00%) 
Investigations         
ALANINE AMINOTRANSFERASE INCREASED   0/161 (0.00%)  1/153 (0.65%)  0/156 (0.00%)  0/159 (0.00%) 
Musculoskeletal and connective tissue disorders         
ARTHRALGIA   0/161 (0.00%)  1/153 (0.65%)  0/156 (0.00%)  0/159 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
RENAL CANCER   1/161 (0.62%)  0/153 (0.00%)  0/156 (0.00%)  1/159 (0.63%) 
LUNG NEOPLASM MALIGNANT   0/161 (0.00%)  0/153 (0.00%)  0/156 (0.00%)  1/159 (0.63%) 
UTERINE LEIOMYOMA   0/161 (0.00%)  0/153 (0.00%)  0/156 (0.00%)  1/159 (0.63%) 
Nervous system disorders         
CRITICAL ILLNESS POLYNEUROPATHY   0/161 (0.00%)  1/153 (0.65%)  0/156 (0.00%)  0/159 (0.00%) 
ISCHAEMIC STROKE   0/161 (0.00%)  0/153 (0.00%)  0/156 (0.00%)  1/159 (0.63%) 
Renal and urinary disorders         
CALCULUS URETERIC   0/161 (0.00%)  0/153 (0.00%)  0/156 (0.00%)  1/159 (0.63%) 
Reproductive system and breast disorders         
OVARIAN CYST   1/161 (0.62%)  0/153 (0.00%)  0/156 (0.00%)  0/159 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
ASTHMA   4/161 (2.48%)  3/153 (1.96%)  4/156 (2.56%)  3/159 (1.89%) 
ASTHMATIC CRISIS   0/161 (0.00%)  1/153 (0.65%)  0/156 (0.00%)  0/159 (0.00%) 
Vascular disorders         
PERIPHERAL EMBOLISM   0/161 (0.00%)  0/153 (0.00%)  1/156 (0.64%)  0/159 (0.00%) 
HYPERTENSION   0/161 (0.00%)  0/153 (0.00%)  0/156 (0.00%)  1/159 (0.63%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
AZD5069 45 mg BID AZD5069 15 mg BID AZD5069 5 mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   86/161 (53.42%)   68/153 (44.44%)   74/156 (47.44%)   96/159 (60.38%) 
Gastrointestinal disorders         
ABDOMINAL PAIN UPPER   2/161 (1.24%)  4/153 (2.61%)  4/156 (2.56%)  1/159 (0.63%) 
NAUSEA   3/161 (1.86%)  3/153 (1.96%)  2/156 (1.28%)  3/159 (1.89%) 
DIARRHOEA   4/161 (2.48%)  0/153 (0.00%)  2/156 (1.28%)  2/159 (1.26%) 
GASTROOESOPHAGEAL REFLUX DISEASE   4/161 (2.48%)  0/153 (0.00%)  1/156 (0.64%)  1/159 (0.63%) 
Other   8/161 (4.97%)  4/153 (2.61%)  1/156 (0.64%)  7/159 (4.40%) 
Infections and infestations         
NASOPHARYNGITIS   18/161 (11.18%)  13/153 (8.50%)  18/156 (11.54%)  31/159 (19.50%) 
BRONCHITIS   7/161 (4.35%)  6/153 (3.92%)  1/156 (0.64%)  10/159 (6.29%) 
PHARYNGITIS   3/161 (1.86%)  4/153 (2.61%)  5/156 (3.21%)  5/159 (3.14%) 
VIRAL UPPER RESPIRATORY TRACT INFECTION   6/161 (3.73%)  3/153 (1.96%)  3/156 (1.92%)  2/159 (1.26%) 
UPPER RESPIRATORY TRACT INFECTION   3/161 (1.86%)  2/153 (1.31%)  6/156 (3.85%)  3/159 (1.89%) 
INFLUENZA   3/161 (1.86%)  3/153 (1.96%)  4/156 (2.56%)  3/159 (1.89%) 
PNEUMONIA   4/161 (2.48%)  2/153 (1.31%)  1/156 (0.64%)  3/159 (1.89%) 
RHINITIS   2/161 (1.24%)  4/153 (2.61%)  1/156 (0.64%)  0/159 (0.00%) 
SINUSITIS   3/161 (1.86%)  1/153 (0.65%)  3/156 (1.92%)  5/159 (3.14%) 
LOWER RESPIRATORY TRACT INFECTION   4/161 (2.48%)  1/153 (0.65%)  1/156 (0.64%)  3/159 (1.89%) 
URINARY TRACT INFECTION   3/161 (1.86%)  3/153 (1.96%)  0/156 (0.00%)  2/159 (1.26%) 
GASTROENTERITIS   1/161 (0.62%)  2/153 (1.31%)  1/156 (0.64%)  2/159 (1.26%) 
Other   0/161 (0.00%)  1/153 (0.65%)  4/156 (2.56%)  0/159 (0.00%) 
Musculoskeletal and connective tissue disorders         
BACK PAIN   2/161 (1.24%)  4/153 (2.61%)  1/156 (0.64%)  6/159 (3.77%) 
ARTHRALGIA   1/161 (0.62%)  2/153 (1.31%)  2/156 (1.28%)  2/159 (1.26%) 
Other   5/161 (3.11%)  2/153 (1.31%)  5/156 (3.21%)  5/159 (3.14%) 
Nervous system disorders         
HEADACHE   12/161 (7.45%)  12/153 (7.84%)  6/156 (3.85%)  15/159 (9.43%) 
Other   5/161 (3.11%)  2/153 (1.31%)  3/156 (1.92%)  3/159 (1.89%) 
Respiratory, thoracic and mediastinal disorders         
COUGH   1/161 (0.62%)  2/153 (1.31%)  3/156 (1.92%)  0/159 (0.00%) 
Other   5/161 (3.11%)  5/153 (3.27%)  1/156 (0.64%)  7/159 (4.40%) 
ASTHMA   4/161 (2.48%)  3/153 (1.96%)  4/156 (2.56%)  3/159 (1.89%) 
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Medical Science Director Bengt Larsson
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01704495     History of Changes
Other Study ID Numbers: D3551C00001
2012-001869-33
First Submitted: October 9, 2012
First Posted: October 11, 2012
Results First Submitted: June 30, 2015
Results First Posted: March 1, 2016
Last Update Posted: March 1, 2016