Trial Outcomes & Findings for A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma. (NCT NCT01704495)
NCT ID: NCT01704495
Last Updated: 2016-03-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1147 participants
Primary outcome timeframe
From start of treatment up to 6 months
Results posted on
2016-03-01
Participant Flow
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.
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.
Participant milestones
| Measure |
AZD5069 45 mg BID
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
AZD5069 oral capsules self-administered twice daily
|
Placebo
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Subjects Randomized
STARTED
|
162
|
156
|
160
|
162
|
|
Subjects Randomized
COMPLETED
|
140
|
141
|
144
|
145
|
|
Subjects Randomized
NOT COMPLETED
|
22
|
15
|
16
|
17
|
|
Optional Safety Extension
STARTED
|
116
|
121
|
114
|
116
|
|
Optional Safety Extension
COMPLETED
|
87
|
88
|
83
|
85
|
|
Optional Safety Extension
NOT COMPLETED
|
29
|
33
|
31
|
31
|
Reasons for withdrawal
| Measure |
AZD5069 45 mg BID
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
AZD5069 oral capsules self-administered twice daily
|
Placebo
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Subjects Randomized
Other Reason
|
3
|
2
|
3
|
2
|
|
Subjects Randomized
Discontinuation criteria met
|
4
|
2
|
2
|
0
|
|
Subjects Randomized
Adverse Event
|
8
|
2
|
0
|
7
|
|
Subjects Randomized
Withdrawal by Subject
|
5
|
5
|
5
|
5
|
|
Subjects Randomized
Protocol Violation
|
1
|
1
|
2
|
0
|
|
Subjects Randomized
Eligibility criteria not fulfilled
|
1
|
3
|
4
|
3
|
|
Optional Safety Extension
Adverse Event
|
0
|
4
|
0
|
1
|
|
Optional Safety Extension
Other reason
|
27
|
29
|
30
|
28
|
|
Optional Safety Extension
Withdrawal by Subject
|
2
|
0
|
1
|
2
|
Baseline Characteristics
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
Baseline characteristics by cohort
| Measure |
AZD5069 45 mg BID
n=162 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=160 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=162 Participants
Placebo oral capsules self-administred twice daily
|
Total
n=640 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
52 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
53 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
54 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
52 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
444 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
196 Participants
n=21 Participants
|
|
FEV1 pre-bronchodilator
|
63.74 percentage of predicted normal
n=5 Participants
|
66.35 percentage of predicted normal
n=7 Participants
|
65.76 percentage of predicted normal
n=5 Participants
|
61.58 percentage of predicted normal
n=4 Participants
|
64.93 percentage of predicted normal
n=21 Participants
|
|
FEV1 post-bronchodilator
|
74.34 percentage of predicted normal
n=5 Participants
|
77.95 percentage of predicted normal
n=7 Participants
|
76.31 percentage of predicted normal
n=5 Participants
|
72.19 percentage of predicted normal
n=4 Participants
|
75.22 percentage of predicted normal
n=21 Participants
|
|
Reversibility
|
18.73 percentage change
STANDARD_DEVIATION 20.617 • n=5 Participants
|
16.05 percentage change
STANDARD_DEVIATION 15.580 • n=7 Participants
|
18.41 percentage change
STANDARD_DEVIATION 20.574 • n=5 Participants
|
18.45 percentage change
STANDARD_DEVIATION 16.342 • n=4 Participants
|
17.93 percentage change
STANDARD_DEVIATION 18.438 • n=21 Participants
|
PRIMARY outcome
Timeframe: From start of treatment up to 6 monthsPopulation: Full analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=161 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=153 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=159 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Rate of Severe Asthma Exacerbations During 6 Months
|
0.31 Exacerbations per 6 month
Interval 0.2 to 0.5
|
0.31 Exacerbations per 6 month
Interval 0.19 to 0.49
|
0.26 Exacerbations per 6 month
Interval 0.16 to 0.42
|
0.20 Exacerbations per 6 month
Interval 0.12 to 0.33
|
SECONDARY outcome
Timeframe: From start of treatment up to 6 monthsOutcome measures
| Measure |
AZD5069 45 mg BID
n=161 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=153 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=159 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months
|
0.04 Exacerbations per 6 month
Interval 0.01 to 0.14
|
0.02 Exacerbations per 6 month
Interval 0.0 to 0.09
|
0.02 Exacerbations per 6 month
Interval 0.02 to 0.09
|
0.02 Exacerbations per 6 month
Interval 0.01 to 0.09
|
SECONDARY outcome
Timeframe: From start of treatment up to 6 monthsPopulation: Full analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=161 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=153 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=159 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions
|
0.54 Days
Interval 0.26 to 1.12
|
0.82 Days
Interval 0.38 to 1.77
|
0.00 Days
Interval 0.0 to 0.01
|
0.08 Days
Interval 0.03 to 0.23
|
SECONDARY outcome
Timeframe: From start of treatment up to 6 monthsPopulation: Full analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=161 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=153 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=159 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms
|
2.38 Days
Interval 1.33 to 4.26
|
2.43 Days
Interval 1.33 to 4.45
|
2.74 Days
Interval 1.42 to 5.29
|
1.55 Days
Interval 0.8 to 3.0
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 2 weeks after Day 0Population: Full analysis set
Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis
Outcome measures
| Measure |
AZD5069 45 mg BID
n=155 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=145 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=149 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=155 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1
|
0.13 L
Interval 0.06 to 0.2
|
0.07 L
Interval 0.0 to 0.14
|
0.09 L
Interval 0.02 to 0.16
|
0.12 L
Interval 0.05 to 0.19
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 1 month after Day 0Only patients with both a non-missing value at baseline and visit at one month are included in the analysis
Outcome measures
| Measure |
AZD5069 45 mg BID
n=153 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=146 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=146 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=153 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1
|
0.14 L
Interval 0.07 to 0.21
|
0.08 L
Interval 0.01 to 0.16
|
0.09 L
Interval 0.02 to 0.16
|
0.09 L
Interval 0.02 to 0.16
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 2 months after Day 0Population: Full analysis set
Only patients with both a non-missing value at baseline and visit at two months are included in the analysis
Outcome measures
| Measure |
AZD5069 45 mg BID
n=150 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=143 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=145 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=150 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1
|
0.13 L
Interval 0.06 to 0.2
|
0.08 L
Interval 0.01 to 0.16
|
0.07 L
Interval -0.01 to 0.14
|
0.12 L
Interval 0.05 to 0.19
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 3 months after Day 0Population: Full analysis set
Only patients with both a non-missing value at baseline and visit at three months are included in the analysis
Outcome measures
| Measure |
AZD5069 45 mg BID
n=146 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=142 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=145 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=149 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1
|
0.10 L
Interval 0.03 to 0.18
|
0.11 L
Interval 0.04 to 0.18
|
0.06 L
Interval -0.02 to 0.13
|
0.06 L
Interval -0.01 to 0.13
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 4 months after Day 0Population: Full analysis set
Only patients with both a non-missing value at baseline and visit at four months are included in the analysis
Outcome measures
| Measure |
AZD5069 45 mg BID
n=148 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=142 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=146 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=148 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1
|
0.17 L
Interval 0.09 to 0.24
|
0.17 L
Interval 0.09 to 0.24
|
0.14 L
Interval 0.06 to 0.21
|
0.16 L
Interval 0.08 to 0.23
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 6 months after Day 0Population: Full Analysis set
Only patients with both a non-missing value at baseline and visit at six months are included in the analysis
Outcome measures
| Measure |
AZD5069 45 mg BID
n=144 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=140 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=145 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=149 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1
|
0.14 L
Interval 0.06 to 0.21
|
0.09 L
Interval 0.01 to 0.16
|
0.10 L
Interval 0.03 to 0.18
|
0.11 L
Interval 0.04 to 0.18
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 2 weeks after Day 0Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis
Outcome measures
| Measure |
AZD5069 45 mg BID
n=146 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=139 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=143 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=146 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1
|
0.06 L
Interval 0.01 to 0.11
|
0.05 L
Interval -0.01 to 0.1
|
0.03 L
Interval -0.02 to 0.09
|
0.03 L
Interval -0.02 to 0.09
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 1 month after Day 0Population: Full Analysis set
Only patients with both a non-missing value at baseline and visit at one month are included in the analysis
Outcome measures
| Measure |
AZD5069 45 mg BID
n=144 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=140 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=141 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=142 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1
|
0.06 L
Interval 0.01 to 0.12
|
0.05 L
Interval 0.0 to 0.11
|
0.03 L
Interval -0.03 to 0.09
|
0.03 L
Interval -0.03 to 0.08
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 2 months after Day 0Population: Full Analysis set
Only patients with both a non-missing value at baseline and visit at two months are included in the analysis
Outcome measures
| Measure |
AZD5069 45 mg BID
n=142 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=138 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=141 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=142 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1
|
0.03 L
Interval -0.02 to 0.09
|
0.04 L
Interval -0.02 to 0.1
|
0.01 L
Interval -0.05 to 0.07
|
0.02 L
Interval -0.04 to 0.08
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 3 months after Day 0Population: Full Analysis set
Only patients with both a non-missing value at baseline and visit at three months are included in the analysis
Outcome measures
| Measure |
AZD5069 45 mg BID
n=138 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=136 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=141 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=143 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1
|
0.04 L
Interval -0.02 to 0.1
|
0.04 L
Interval -0.02 to 0.1
|
-0.00 L
Interval -0.06 to 0.06
|
-0.01 L
Interval -0.07 to 0.05
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 4 months after Day 0Population: Full Analysis set
Only patients with both a non-missing value at baseline and visit at four months are included in the analysis
Outcome measures
| Measure |
AZD5069 45 mg BID
n=141 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=136 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=141 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=141 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1
|
0.06 L
Interval 0.0 to 0.12
|
0.06 L
Interval 0.0 to 0.13
|
0.03 L
Interval -0.03 to 0.1
|
0.03 L
Interval -0.03 to 0.1
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 6 months after Day 0Population: Full Analysis set
Only patients with both a non-missing value at baseline and visit at six months are included in the analysis
Outcome measures
| Measure |
AZD5069 45 mg BID
n=139 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=136 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=142 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=145 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1
|
0.06 L
Interval 0.01 to 0.12
|
0.02 L
Interval -0.03 to 0.08
|
0.04 L
Interval -0.02 to 0.1
|
-0.01 L
Interval -0.07 to 0.05
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)Population: Full Analysis set
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).
Outcome measures
| Measure |
AZD5069 45 mg BID
n=154 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=149 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=149 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=156 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score
|
-0.68 Units on a scale]
Interval -0.83 to -0.52
|
-0.66 Units on a scale]
Interval -0.82 to -0.51
|
-0.64 Units on a scale]
Interval -0.8 to -0.48
|
-0.70 Units on a scale]
Interval -0.86 to -0.55
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 6 months after Day 0Population: Full Analysis set
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).
Outcome measures
| Measure |
AZD5069 45 mg BID
n=133 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=134 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=134 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=141 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)
|
72 Participants with improvement
|
88 Participants with improvement
|
73 Participants with improvement
|
69 Participants with improvement
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Treatment Period (1,3, and 6 months)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.
Outcome measures
| Measure |
AZD5069 45 mg BID
n=152 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=145 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=145 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=153 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score
|
0.50 Overall Score
Interval 0.36 to 0.65
|
0.46 Overall Score
Interval 0.31 to 0.61
|
0.52 Overall Score
Interval 0.37 to 0.67
|
0.52 Overall Score
Interval 0.38 to 0.67
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and 6 months after Day 0Population: Full Analysis set
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.
Outcome measures
| Measure |
AZD5069 45 mg BID
n=132 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=132 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=131 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=139 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score
|
62 Participants with improvement
|
68 Participants with improvement
|
69 Participants with improvement
|
62 Participants with improvement
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)Population: Full Analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=160 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=153 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=159 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days
|
-0.4 Asthma symptom free days
Interval -3.4 to 2.7
|
1.6 Asthma symptom free days
Interval -1.5 to 4.6
|
1.2 Asthma symptom free days
Interval -2.0 to 4.3
|
1.1 Asthma symptom free days
Interval -1.9 to 4.1
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)Population: Full Analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=158 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=148 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=152 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=155 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days
|
0.2 symptom free days
Interval -4.3 to 4.7
|
2.6 symptom free days
Interval -2.0 to 7.1
|
3.4 symptom free days
Interval -1.2 to 8.1
|
3.1 symptom free days
Interval -1.4 to 7.6
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)Population: Full Analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=155 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=146 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=149 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=154 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days
|
1.4 symptom free days
Interval -3.4 to 6.3
|
4.3 symptom free days
Interval -0.6 to 9.3
|
3.0 symptom free days
Interval -2.1 to 8.0
|
4.0 symptom free days
Interval -0.9 to 8.9
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)Population: Full Analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=152 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=145 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=148 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=151 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days
|
2.6 symptom free days
Interval -2.5 to 7.8
|
5.6 symptom free days
Interval 0.5 to 10.7
|
3.9 symptom free days
Interval -1.3 to 9.2
|
4.4 symptom free days
Interval -0.7 to 9.5
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)Population: Full Analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=160 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=153 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=159 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days
|
-1.1 asthma control days
Interval -3.9 to 1.6
|
1.7 asthma control days
Interval -1.1 to 4.6
|
1.2 asthma control days
Interval -1.7 to 4.1
|
0.9 asthma control days
Interval -1.8 to 3.7
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)Population: Full Analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=158 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=148 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=151 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=155 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days
|
-0.1 asthma control days
Interval -4.2 to 4.0
|
3.5 asthma control days
Interval -0.7 to 7.7
|
2.7 asthma control days
Interval -4.2 to 4.0
|
2.8 asthma control days
Interval -1.4 to 6.9
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)Population: Full Analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=155 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=146 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=149 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=154 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days
|
0.9 asthma control days
Interval -3.8 to 5.6
|
4.7 asthma control days
Interval 0.0 to 9.4
|
3.2 asthma control days
Interval -1.6 to 8.1
|
2.9 asthma control days
Interval -1.8 to 7.6
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 monthsPopulation: Full Analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=152 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=145 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=148 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=151 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days
|
1.4 asthma control days
Interval -3.4 to 6.2
|
5.7 asthma control days
Interval 0.9 to 10.5
|
3.9 asthma control days
Interval -1.0 to 8.8
|
2.4 asthma control days
Interval -2.3 to 7.2
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)Population: Full analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=160 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=153 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=159 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days
|
4.0 rescue medication free days
Interval -0.6 to 8.6
|
8.3 rescue medication free days
Interval 3.6 to 13.0
|
6.8 rescue medication free days
Interval 2.0 to 11.5
|
9.5 rescue medication free days
Interval 4.9 to 14.1
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)Population: Full Analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=158 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=148 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=150 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=155 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days
|
10.7 rescue medication free days
Interval 4.6 to 16.8
|
17.6 rescue medication free days
Interval 11.4 to 23.8
|
15.4 rescue medication free days
Interval 9.1 to 21.8
|
16.4 rescue medication free days
Interval 10.3 to 22.6
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)Outcome measures
| Measure |
AZD5069 45 mg BID
n=155 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=146 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=147 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=153 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days
|
12.3 rescue medication free days
Interval 5.7 to 18.9
|
19.2 rescue medication free days
Interval 12.6 to 25.9
|
19.8 rescue medication free days
Interval 13.0 to 26.6
|
18.7 rescue medication free days
Interval 12.1 to 25.3
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)Population: Full Analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=152 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=145 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=147 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=150 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days
|
15.8 rescue medication free days
Interval 9.0 to 22.7
|
23.1 rescue medication free days
Interval 16.2 to 29.9
|
21.2 rescue medication free days
Interval 14.2 to 28.2
|
20.0 rescue medication free days
Interval 13.2 to 26.8
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)Population: Full analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=161 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=153 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=159 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms
|
-10.1 night time awakenings
Interval -14.6 to -5.5
|
-11.1 night time awakenings
Interval -15.7 to -6.5
|
-11.3 night time awakenings
Interval -16.0 to -6.6
|
-8.9 night time awakenings
Interval -13.4 to -4.3
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)Population: Full Analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=158 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=148 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=152 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=156 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms
|
-15.2 night time awakenings
Interval -20.7 to -9.8
|
-19.0 night time awakenings
Interval -24.5 to -13.5
|
-18.2 night time awakenings
Interval -23.8 to -12.6
|
-15.2 night time awakenings
Interval -20.7 to -9.7
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)Population: full analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=155 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=146 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=149 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=154 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms
|
-17.6 night time awakenings
Interval -23.2 to -11.9
|
-19.8 night time awakenings
Interval -25.5 to -14.0
|
-22.1 night time awakenings
Interval -27.9 to -16.2
|
-16.7 night time awakenings
Interval -22.4 to -11.0
|
SECONDARY outcome
Timeframe: Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)Population: Full analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=153 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=145 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=148 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=152 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms
|
-22.8 night time awakenings
Interval -28.7 to -17.0
|
-25.5 night time awakenings
Interval -31.3 to -19.6
|
-25.3 night time awakenings
Interval -31.3 to -19.3
|
-21.8 night time awakenings
Interval -27.7 to -16.0
|
SECONDARY outcome
Timeframe: Last 2 weeks before randomizationOutcome measures
| Measure |
AZD5069 45 mg BID
n=160 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=153 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=159 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Number of Participants With Well Controlled Asthma Weeks at Baseline
0 Well-controlled asthma weeks Baseline
|
154 participants
|
152 participants
|
150 participants
|
152 participants
|
|
Number of Participants With Well Controlled Asthma Weeks at Baseline
1 Well-controlled asthma weeks Baseline
|
6 participants
|
1 participants
|
4 participants
|
7 participants
|
|
Number of Participants With Well Controlled Asthma Weeks at Baseline
2 Well-controlled asthma weeks Baseline
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 1to end of the 6 months treatment periodPopulation: Full Analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=162 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=160 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=158 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Number of Well Controlled Asthma Weeks During Treatment
|
1.7 well controlled asthma weeks
Standard Deviation 4.38
|
1.9 well controlled asthma weeks
Standard Deviation 4.78
|
2.4 well controlled asthma weeks
Standard Deviation 5.38
|
2.3 well controlled asthma weeks
Standard Deviation 5.27
|
SECONDARY outcome
Timeframe: Last 2 weeks before randomizationPopulation: Full analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=160 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=153 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=158 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline
2 uncontrolled persistent asthma weeks
|
97 participants
|
96 participants
|
96 participants
|
95 participants
|
|
Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline
0 uncontrolled persistent asthma weeks
|
23 participants
|
18 participants
|
26 participants
|
27 participants
|
|
Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline
1 uncontrolled persistent asthma weeks
|
40 participants
|
39 participants
|
34 participants
|
36 participants
|
SECONDARY outcome
Timeframe: Day 1 to end of the 6 months treatment periodPopulation: Full analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=162 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=156 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=160 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=157 Participants
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Number of Uncontrolled Persistent Asthma Weeks During Treatment
|
11.0 uncontrolled persistent asthma weeks
Standard Deviation 10.0
|
10.7 uncontrolled persistent asthma weeks
Standard Deviation 10.02
|
10.4 uncontrolled persistent asthma weeks
Standard Deviation 9.84
|
10.9 uncontrolled persistent asthma weeks
Standard Deviation 9.89
|
SECONDARY outcome
Timeframe: Day 7Population: PK analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=159 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=147 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=144 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Mean Plasma Concentration of AZD5069 at Day 7
|
235.0 (nmol/L)
Geometric Coefficient of Variation 1525.49
|
69.9 (nmol/L)
Geometric Coefficient of Variation 717.83
|
25.4 (nmol/L)
Geometric Coefficient of Variation 511.02
|
—
|
SECONDARY outcome
Timeframe: at 1 monthPopulation: PK analysis set
Outcome measures
| Measure |
AZD5069 45 mg BID
n=148 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=135 Participants
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=139 Participants
AZD5069 oral capsules self-administered twice daily
|
Placebo
Placebo oral capsules self-administred twice daily
|
|---|---|---|---|---|
|
Mean Plasma Concentration of AZD5069 at 1 Month
|
152.2 (nmol/L)
Geometric Coefficient of Variation 11200.64
|
76.4 (nmol/L)
Geometric Coefficient of Variation 788.17
|
25.8 (nmol/L)
Geometric Coefficient of Variation 449.02
|
—
|
Adverse Events
AZD5069 45 mg BID
Serious events: 14 serious events
Other events: 86 other events
Deaths: 0 deaths
AZD5069 15 mg BID
Serious events: 8 serious events
Other events: 68 other events
Deaths: 0 deaths
AZD5069 5 mg BID
Serious events: 7 serious events
Other events: 74 other events
Deaths: 0 deaths
Placebo
Serious events: 13 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD5069 45 mg BID
n=161 participants at risk
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=153 participants at risk
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=156 participants at risk
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=159 participants at risk
Placebo oral capsules self-administered twice daily
|
|---|---|---|---|---|
|
Infections and infestations
PNEUMONIA
|
1.9%
3/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.00%
0/156 • 12 months
|
1.3%
2/159 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.62%
1/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.62%
1/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Infections and infestations
HELICOBACTER GASTRITIS
|
0.00%
0/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.62%
1/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION BACTERIAL
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.64%
1/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Infections and infestations
SALMONELLOSIS
|
0.00%
0/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Infections and infestations
STREPTOCOCCAL SEPSIS
|
0.00%
0/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.62%
1/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Infections and infestations
ACUTE TONSILLITIS
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Nervous system disorders
CRITICAL ILLNESS POLYNEUROPATHY
|
0.00%
0/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.62%
1/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
1.3%
2/159 • 12 months
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Vascular disorders
PERIPHERAL EMBOLISM
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.64%
1/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
2.5%
4/161 • 12 months
|
2.0%
3/153 • 12 months
|
2.6%
4/156 • 12 months
|
1.9%
3/159 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMATIC CRISIS
|
0.00%
0/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Gastrointestinal disorders
BARRETTS OESOPHAGUS
|
0.00%
0/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Gastrointestinal disorders
GASTRITIS
|
0.62%
1/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.00%
0/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.64%
1/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.62%
1/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Congenital, familial and genetic disorders
PSEUDOHYPOPARATHYROIDISM
|
0.00%
0/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.64%
1/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
0.62%
1/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.00%
0/156 • 12 months
|
0.00%
0/159 • 12 months
|
Other adverse events
| Measure |
AZD5069 45 mg BID
n=161 participants at risk
AZD5069 oral capsules self-administered twice daily
|
AZD5069 15 mg BID
n=153 participants at risk
AZD5069 oral capsules self-administered twice daily
|
AZD5069 5 mg BID
n=156 participants at risk
AZD5069 oral capsules self-administered twice daily
|
Placebo
n=159 participants at risk
Placebo oral capsules self-administered twice daily
|
|---|---|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
11.2%
18/161 • 12 months
|
8.5%
13/153 • 12 months
|
11.5%
18/156 • 12 months
|
19.5%
31/159 • 12 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.2%
2/161 • 12 months
|
2.6%
4/153 • 12 months
|
0.64%
1/156 • 12 months
|
3.8%
6/159 • 12 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.62%
1/161 • 12 months
|
1.3%
2/153 • 12 months
|
1.3%
2/156 • 12 months
|
1.3%
2/159 • 12 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.2%
2/161 • 12 months
|
2.6%
4/153 • 12 months
|
2.6%
4/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Gastrointestinal disorders
NAUSEA
|
1.9%
3/161 • 12 months
|
2.0%
3/153 • 12 months
|
1.3%
2/156 • 12 months
|
1.9%
3/159 • 12 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.5%
4/161 • 12 months
|
0.00%
0/153 • 12 months
|
1.3%
2/156 • 12 months
|
1.3%
2/159 • 12 months
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
2.5%
4/161 • 12 months
|
0.00%
0/153 • 12 months
|
0.64%
1/156 • 12 months
|
0.63%
1/159 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.62%
1/161 • 12 months
|
1.3%
2/153 • 12 months
|
1.9%
3/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Nervous system disorders
HEADACHE
|
7.5%
12/161 • 12 months
|
7.8%
12/153 • 12 months
|
3.8%
6/156 • 12 months
|
9.4%
15/159 • 12 months
|
|
Infections and infestations
BRONCHITIS
|
4.3%
7/161 • 12 months
|
3.9%
6/153 • 12 months
|
0.64%
1/156 • 12 months
|
6.3%
10/159 • 12 months
|
|
Infections and infestations
PHARYNGITIS
|
1.9%
3/161 • 12 months
|
2.6%
4/153 • 12 months
|
3.2%
5/156 • 12 months
|
3.1%
5/159 • 12 months
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
3.7%
6/161 • 12 months
|
2.0%
3/153 • 12 months
|
1.9%
3/156 • 12 months
|
1.3%
2/159 • 12 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.9%
3/161 • 12 months
|
1.3%
2/153 • 12 months
|
3.8%
6/156 • 12 months
|
1.9%
3/159 • 12 months
|
|
Infections and infestations
INFLUENZA
|
1.9%
3/161 • 12 months
|
2.0%
3/153 • 12 months
|
2.6%
4/156 • 12 months
|
1.9%
3/159 • 12 months
|
|
Infections and infestations
PNEUMONIA
|
2.5%
4/161 • 12 months
|
1.3%
2/153 • 12 months
|
0.64%
1/156 • 12 months
|
1.9%
3/159 • 12 months
|
|
Infections and infestations
RHINITIS
|
1.2%
2/161 • 12 months
|
2.6%
4/153 • 12 months
|
0.64%
1/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Infections and infestations
SINUSITIS
|
1.9%
3/161 • 12 months
|
0.65%
1/153 • 12 months
|
1.9%
3/156 • 12 months
|
3.1%
5/159 • 12 months
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
2.5%
4/161 • 12 months
|
0.65%
1/153 • 12 months
|
0.64%
1/156 • 12 months
|
1.9%
3/159 • 12 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.9%
3/161 • 12 months
|
2.0%
3/153 • 12 months
|
0.00%
0/156 • 12 months
|
1.3%
2/159 • 12 months
|
|
Infections and infestations
GASTROENTERITIS
|
0.62%
1/161 • 12 months
|
1.3%
2/153 • 12 months
|
0.64%
1/156 • 12 months
|
1.3%
2/159 • 12 months
|
|
Infections and infestations
Other
|
0.00%
0/161 • 12 months
|
0.65%
1/153 • 12 months
|
2.6%
4/156 • 12 months
|
0.00%
0/159 • 12 months
|
|
Nervous system disorders
Other
|
3.1%
5/161 • 12 months
|
1.3%
2/153 • 12 months
|
1.9%
3/156 • 12 months
|
1.9%
3/159 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
3.1%
5/161 • 12 months
|
3.3%
5/153 • 12 months
|
0.64%
1/156 • 12 months
|
4.4%
7/159 • 12 months
|
|
Gastrointestinal disorders
Other
|
5.0%
8/161 • 12 months
|
2.6%
4/153 • 12 months
|
0.64%
1/156 • 12 months
|
4.4%
7/159 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Other
|
3.1%
5/161 • 12 months
|
1.3%
2/153 • 12 months
|
3.2%
5/156 • 12 months
|
3.1%
5/159 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
2.5%
4/161 • 12 months
|
2.0%
3/153 • 12 months
|
2.6%
4/156 • 12 months
|
1.9%
3/159 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60