Trial Outcomes & Findings for Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients (NCT NCT01197794)
NCT ID: NCT01197794
Last Updated: 2013-11-06
Results Overview
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
COMPLETED
PHASE2
1144 participants
Twelve week treatment period
2013-11-06
Participant Flow
1144 participants were randomized. The first participant was enrolled on 19 October 2010 and the last participant completed the study on 16 February 2012.
Participants were screened for a period of 31 days out of which 17 days for enrollment and 2 weeks for run-in period.
Participant milestones
| Measure |
AZD1981 400 mg
AZD1981 400 mg twice daily
|
AZD1981 200 mg
AZD1981 200 mg once daily
|
AZD1981 100 mg
AZD1981 100 mg twice daily
|
AZD1981 80 mg
AZD1981 80 mg once daily
|
AZD1981 40 mg
AZD1981 40 mg twice daily
|
AZD1981 10 mg
AZD1981 10 mg twice daily
|
Placebo
Placebo
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
164
|
161
|
166
|
164
|
163
|
163
|
163
|
|
Overall Study
COMPLETED
|
148
|
146
|
153
|
152
|
149
|
144
|
142
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
13
|
12
|
14
|
19
|
21
|
Reasons for withdrawal
| Measure |
AZD1981 400 mg
AZD1981 400 mg twice daily
|
AZD1981 200 mg
AZD1981 200 mg once daily
|
AZD1981 100 mg
AZD1981 100 mg twice daily
|
AZD1981 80 mg
AZD1981 80 mg once daily
|
AZD1981 40 mg
AZD1981 40 mg twice daily
|
AZD1981 10 mg
AZD1981 10 mg twice daily
|
Placebo
Placebo
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
4
|
4
|
4
|
2
|
3
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Overall Study
Development of study withdrawal criteria
|
3
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Eligibility criteria not fulfilled
|
5
|
8
|
2
|
5
|
5
|
9
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
4
|
1
|
1
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Other
|
1
|
1
|
3
|
0
|
2
|
2
|
4
|
Baseline Characteristics
Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients
Baseline characteristics by cohort
| Measure |
AZD1981 400 mg
n=164 Participants
AZD1981 400 mg twice daily
|
AZD1981 200 mg
n=161 Participants
AZD1981 200 mg once daily
|
AZD1981 100 mg
n=166 Participants
AZD1981 100 mg twice daily
|
AZD1981 80 mg
n=164 Participants
AZD1981 80 mg once daily
|
AZD1981 40 mg
n=162 Participants
AZD1981 40 mg twice daily
|
AZD1981 10 mg
n=163 Participants
AZD1981 10 mg twice daily
|
Placebo
n=161 Participants
Placebo
|
Total
n=1141 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age Continuous
|
46.6 Years
STANDARD_DEVIATION 13.98 • n=5 Participants
|
46.7 Years
STANDARD_DEVIATION 12.84 • n=7 Participants
|
46.4 Years
STANDARD_DEVIATION 14.65 • n=5 Participants
|
45.4 Years
STANDARD_DEVIATION 13.22 • n=4 Participants
|
46.3 Years
STANDARD_DEVIATION 13.15 • n=21 Participants
|
44.5 Years
STANDARD_DEVIATION 13.76 • n=10 Participants
|
45.7 Years
STANDARD_DEVIATION 13.50 • n=115 Participants
|
45.9 Years
STANDARD_DEVIATION 13.58 • n=6 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
80 Participants
n=10 Participants
|
76 Participants
n=115 Participants
|
561 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
83 Participants
n=10 Participants
|
85 Participants
n=115 Participants
|
580 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
117 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
113 Participants
n=10 Participants
|
119 Participants
n=115 Participants
|
824 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
26 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Asian
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
195 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Other
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
94 Participants
n=6 Participants
|
|
Time since asthma diagnosis
|
18.6 Years
STANDARD_DEVIATION 13.87 • n=5 Participants
|
18.5 Years
STANDARD_DEVIATION 14.25 • n=7 Participants
|
18.6 Years
STANDARD_DEVIATION 14.74 • n=5 Participants
|
18.3 Years
STANDARD_DEVIATION 13.04 • n=4 Participants
|
18.0 Years
STANDARD_DEVIATION 14.35 • n=21 Participants
|
17.3 Years
STANDARD_DEVIATION 12.40 • n=10 Participants
|
17.5 Years
STANDARD_DEVIATION 13.27 • n=115 Participants
|
18.1 Years
STANDARD_DEVIATION 13.70 • n=6 Participants
|
|
Smoking status
Former smoker
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
144 Participants
n=6 Participants
|
|
Smoking status
Never
|
139 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
144 Participants
n=10 Participants
|
146 Participants
n=115 Participants
|
997 Participants
n=6 Participants
|
|
Pre-bronchodilator FEV1 percentage of predicted normal (PN) at randomization
|
70.03 Percentage of predicted normal
STANDARD_DEVIATION 10.544 • n=5 Participants
|
68.86 Percentage of predicted normal
STANDARD_DEVIATION 11.580 • n=7 Participants
|
68.86 Percentage of predicted normal
STANDARD_DEVIATION 11.774 • n=5 Participants
|
68.56 Percentage of predicted normal
STANDARD_DEVIATION 12.186 • n=4 Participants
|
67.28 Percentage of predicted normal
STANDARD_DEVIATION 11.732 • n=21 Participants
|
69.06 Percentage of predicted normal
STANDARD_DEVIATION 12.132 • n=10 Participants
|
68.52 Percentage of predicted normal
STANDARD_DEVIATION 11.319 • n=115 Participants
|
68.73 Percentage of predicted normal
STANDARD_DEVIATION 11.615 • n=6 Participants
|
|
Total daily dose of inhaled glucocorticosteroids (ICS)
|
406.31 µg
n=5 Participants
|
399.75 µg
n=7 Participants
|
413.70 µg
n=5 Participants
|
396.46 µg
n=4 Participants
|
405.56 µg
n=21 Participants
|
418.19 µg
n=10 Participants
|
410.99 µg
n=115 Participants
|
407.30 µg
n=6 Participants
|
PRIMARY outcome
Timeframe: Twelve week treatment periodPopulation: The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
Outcome measures
| Measure |
Arm 1 - AZD1981 400 mg
n=160 Participants
AZD1981 400 mg twice daily
|
Arm 2 - AZD1981 200 mg
n=156 Participants
AZD1981 200 mg once daily
|
Arm 3 - AZD1981 100 mg
n=162 Participants
AZD1981 100 mg twice daily
|
Arm 4 - AZD1981 80 mg
n=159 Participants
AZD1981 80 mg once daily
|
Arm 5 - AZD1981 40 mg
n=158 Participants
AZD1981 40 mg twice daily
|
Arm 6 - AZD1981 10 mg
n=157 Participants
AZD1981 10 mg twice daily
|
Arm7-Placebo
n=154 Participants
Placebo
|
|---|---|---|---|---|---|---|---|
|
Pre-bronchodilator FEV1 at the Clinic
|
0.16 Liters
Interval 0.1 to 0.21
|
0.19 Liters
Interval 0.14 to 0.25
|
0.19 Liters
Interval 0.13 to 0.24
|
0.15 Liters
Interval 0.1 to 0.21
|
0.20 Liters
Interval 0.15 to 0.26
|
0.15 Liters
Interval 0.1 to 0.21
|
0.14 Liters
Interval 0.08 to 0.19
|
SECONDARY outcome
Timeframe: Twelve week treatment periodPopulation: The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available morning (evening) PEF during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
Outcome measures
| Measure |
Arm 1 - AZD1981 400 mg
n=163 Participants
AZD1981 400 mg twice daily
|
Arm 2 - AZD1981 200 mg
n=159 Participants
AZD1981 200 mg once daily
|
Arm 3 - AZD1981 100 mg
n=164 Participants
AZD1981 100 mg twice daily
|
Arm 4 - AZD1981 80 mg
n=164 Participants
AZD1981 80 mg once daily
|
Arm 5 - AZD1981 40 mg
n=161 Participants
AZD1981 40 mg twice daily
|
Arm 6 - AZD1981 10 mg
n=162 Participants
AZD1981 10 mg twice daily
|
Arm7-Placebo
n=160 Participants
Placebo
|
|---|---|---|---|---|---|---|---|
|
Morning and Evening PEF
Morning PEF
|
5.80 Liters/minute
Interval -0.99 to 12.59
|
0.60 Liters/minute
Interval -6.26 to 7.47
|
4.70 Liters/minute
Interval -2.06 to 11.46
|
0.06 Liters/minute
Interval -6.7 to 6.82
|
9.36 Liters/minute
Interval 2.54 to 16.18
|
0.36 Liters/minute
Interval -6.44 to 7.16
|
-1.65 Liters/minute
Interval -8.49 to 5.18
|
|
Morning and Evening PEF
Evening PEF
|
0.78 Liters/minute
Interval -6.15 to 7.72
|
-1.51 Liters/minute
Interval -8.54 to 5.52
|
-0.20 Liters/minute
Interval -7.11 to 6.71
|
-5.34 Liters/minute
Interval -12.25 to 1.57
|
7.20 Liters/minute
Interval 0.21 to 14.19
|
-2.93 Liters/minute
Interval -9.88 to 4.02
|
0.27 Liters/minute
Interval -6.69 to 7.24
|
SECONDARY outcome
Timeframe: Twelve week treatment periodPopulation: The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint
The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. The minimal important difference is defined as a change in score of 0.5. Change from baseline: treatment period average minus baseline.
Outcome measures
| Measure |
Arm 1 - AZD1981 400 mg
n=156 Participants
AZD1981 400 mg twice daily
|
Arm 2 - AZD1981 200 mg
n=153 Participants
AZD1981 200 mg once daily
|
Arm 3 - AZD1981 100 mg
n=160 Participants
AZD1981 100 mg twice daily
|
Arm 4 - AZD1981 80 mg
n=157 Participants
AZD1981 80 mg once daily
|
Arm 5 - AZD1981 40 mg
n=155 Participants
AZD1981 40 mg twice daily
|
Arm 6 - AZD1981 10 mg
n=152 Participants
AZD1981 10 mg twice daily
|
Arm7-Placebo
n=148 Participants
Placebo
|
|---|---|---|---|---|---|---|---|
|
Asthma Control Questionnaire 5-item (ACQ5)
|
-0.88 Scores on scale
Interval -1.0 to -0.76
|
-0.88 Scores on scale
Interval -1.01 to -0.76
|
-0.87 Scores on scale
Interval -0.99 to -0.75
|
-0.90 Scores on scale
Interval -1.03 to -0.78
|
-0.98 Scores on scale
Interval -1.1 to -0.86
|
-0.83 Scores on scale
Interval -0.96 to -0.71
|
-0.78 Scores on scale
Interval -0.91 to -0.66
|
SECONDARY outcome
Timeframe: Twelve week treatment periodPopulation: All randomized participants who received at least one dose of study medication and from whom any data after randomization was available
Number of participants who had at least one adverse event during the randomized treatment period
Outcome measures
| Measure |
Arm 1 - AZD1981 400 mg
n=164 Participants
AZD1981 400 mg twice daily
|
Arm 2 - AZD1981 200 mg
n=159 Participants
AZD1981 200 mg once daily
|
Arm 3 - AZD1981 100 mg
n=164 Participants
AZD1981 100 mg twice daily
|
Arm 4 - AZD1981 80 mg
n=164 Participants
AZD1981 80 mg once daily
|
Arm 5 - AZD1981 40 mg
n=163 Participants
AZD1981 40 mg twice daily
|
Arm 6 - AZD1981 10 mg
n=163 Participants
AZD1981 10 mg twice daily
|
Arm7-Placebo
n=163 Participants
Placebo
|
|---|---|---|---|---|---|---|---|
|
Adverse Events
|
46 Participants
|
46 Participants
|
46 Participants
|
40 Participants
|
49 Participants
|
56 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Twelve week treatment periodPopulation: The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint
Severe asthma exacerbation defined as deterioration in asthma leading to either hospitalization/emergency room treatment or oral glucocorticosteroid treatment for at least 3 days
Outcome measures
| Measure |
Arm 1 - AZD1981 400 mg
n=164 Participants
AZD1981 400 mg twice daily
|
Arm 2 - AZD1981 200 mg
n=159 Participants
AZD1981 200 mg once daily
|
Arm 3 - AZD1981 100 mg
n=164 Participants
AZD1981 100 mg twice daily
|
Arm 4 - AZD1981 80 mg
n=164 Participants
AZD1981 80 mg once daily
|
Arm 5 - AZD1981 40 mg
n=162 Participants
AZD1981 40 mg twice daily
|
Arm 6 - AZD1981 10 mg
n=163 Participants
AZD1981 10 mg twice daily
|
Arm7-Placebo
n=161 Participants
Placebo
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Severe Asthma Exacerbation
|
4 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Twelve week treatment periodPopulation: The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint
Treatment failure is defined as a clinical need for additional inhaled corticosteroid use as judged by the investigator based on evaluations at the clinic.
Outcome measures
| Measure |
Arm 1 - AZD1981 400 mg
n=164 Participants
AZD1981 400 mg twice daily
|
Arm 2 - AZD1981 200 mg
n=159 Participants
AZD1981 200 mg once daily
|
Arm 3 - AZD1981 100 mg
n=164 Participants
AZD1981 100 mg twice daily
|
Arm 4 - AZD1981 80 mg
n=164 Participants
AZD1981 80 mg once daily
|
Arm 5 - AZD1981 40 mg
n=162 Participants
AZD1981 40 mg twice daily
|
Arm 6 - AZD1981 10 mg
n=163 Participants
AZD1981 10 mg twice daily
|
Arm7-Placebo
n=161 Participants
Placebo
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Treatment Failure
|
4 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
10 Participants
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Twelve week treatment periodPopulation: The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint
The ACQ5 consists of 5 questions, each assessed on a scale from 0-6, where 0 represents good asthma control and 6 represents poor asthma control. The overall score is the mean of the responses. Well-controlled asthma is defined as ACQ5\<=0.75 at the end of the 12-week treatment period.
Outcome measures
| Measure |
Arm 1 - AZD1981 400 mg
n=164 Participants
AZD1981 400 mg twice daily
|
Arm 2 - AZD1981 200 mg
n=159 Participants
AZD1981 200 mg once daily
|
Arm 3 - AZD1981 100 mg
n=164 Participants
AZD1981 100 mg twice daily
|
Arm 4 - AZD1981 80 mg
n=164 Participants
AZD1981 80 mg once daily
|
Arm 5 - AZD1981 40 mg
n=162 Participants
AZD1981 40 mg twice daily
|
Arm 6 - AZD1981 10 mg
n=163 Participants
AZD1981 10 mg twice daily
|
Arm7-Placebo
n=161 Participants
Placebo
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Well-controlled Asthma (ACQ5<=0.75)
|
34 Participants
|
33 Participants
|
34 Participants
|
34 Participants
|
36 Participants
|
30 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Twelve week treatment periodPopulation: The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint
The AQLQ(S) consists of 32 questions, each assessed on a scale from 1-7, with higher values indicating better health-related quality of life. Overall scores are calculated from the means of the individual scores. The minimal important difference is a change in score of 0.5. Change from baseline: treatment period average minus baseline.
Outcome measures
| Measure |
Arm 1 - AZD1981 400 mg
n=156 Participants
AZD1981 400 mg twice daily
|
Arm 2 - AZD1981 200 mg
n=152 Participants
AZD1981 200 mg once daily
|
Arm 3 - AZD1981 100 mg
n=160 Participants
AZD1981 100 mg twice daily
|
Arm 4 - AZD1981 80 mg
n=157 Participants
AZD1981 80 mg once daily
|
Arm 5 - AZD1981 40 mg
n=155 Participants
AZD1981 40 mg twice daily
|
Arm 6 - AZD1981 10 mg
n=152 Participants
AZD1981 10 mg twice daily
|
Arm7-Placebo
n=148 Participants
Placebo
|
|---|---|---|---|---|---|---|---|
|
Asthma Quality of Life Questionnaire (AQLQ(S))
|
0.73 Score on scale
Interval 0.6 to 0.85
|
0.73 Score on scale
Interval 0.61 to 0.86
|
0.75 Score on scale
Interval 0.63 to 0.87
|
0.80 Score on scale
Interval 0.68 to 0.92
|
0.82 Score on scale
Interval 0.69 to 0.94
|
0.72 Score on scale
Interval 0.59 to 0.84
|
0.65 Score on scale
Interval 0.53 to 0.78
|
SECONDARY outcome
Timeframe: Twelve week treatment periodPopulation: The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint
Asthma symptoms, measured in the morning and evening, based on a scale from 0-3 with higher scores indicating more severe asthma symptoms. Total asthma symptom score (0-6) is calculated by taking the sum of the morning and evening scores. Change from baseline: treatment period average minus baseline.
Outcome measures
| Measure |
Arm 1 - AZD1981 400 mg
n=164 Participants
AZD1981 400 mg twice daily
|
Arm 2 - AZD1981 200 mg
n=158 Participants
AZD1981 200 mg once daily
|
Arm 3 - AZD1981 100 mg
n=164 Participants
AZD1981 100 mg twice daily
|
Arm 4 - AZD1981 80 mg
n=164 Participants
AZD1981 80 mg once daily
|
Arm 5 - AZD1981 40 mg
n=162 Participants
AZD1981 40 mg twice daily
|
Arm 6 - AZD1981 10 mg
n=163 Participants
AZD1981 10 mg twice daily
|
Arm7-Placebo
n=160 Participants
Placebo
|
|---|---|---|---|---|---|---|---|
|
Asthma Symptom Score
|
-0.30 Score on scale
Interval -0.42 to -0.18
|
-0.26 Score on scale
Interval -0.38 to -0.14
|
-0.28 Score on scale
Interval -0.4 to -0.16
|
-0.33 Score on scale
Interval -0.45 to -0.21
|
-0.34 Score on scale
Interval -0.46 to -0.22
|
-0.30 Score on scale
Interval -0.42 to -0.17
|
-0.27 Score on scale
Interval -0.39 to -0.15
|
SECONDARY outcome
Timeframe: Twelve week treatment periodPopulation: The full analysis set consist of all randomized participants who received at least one dose of study medication and contributed sufficient data for at least the primary or secondary efficacy endpoint
Reliever medication use (number of inhalations), measured in the morning and evening. Total reliever medication use is calculated by taking the sum of the number of daytime and evening inhalations of reliever medication. Change from baseline: treatment period average minus baseline.
Outcome measures
| Measure |
Arm 1 - AZD1981 400 mg
n=164 Participants
AZD1981 400 mg twice daily
|
Arm 2 - AZD1981 200 mg
n=158 Participants
AZD1981 200 mg once daily
|
Arm 3 - AZD1981 100 mg
n=164 Participants
AZD1981 100 mg twice daily
|
Arm 4 - AZD1981 80 mg
n=164 Participants
AZD1981 80 mg once daily
|
Arm 5 - AZD1981 40 mg
n=162 Participants
AZD1981 40 mg twice daily
|
Arm 6 - AZD1981 10 mg
n=163 Participants
AZD1981 10 mg twice daily
|
Arm7-Placebo
n=160 Participants
Placebo
|
|---|---|---|---|---|---|---|---|
|
Total Reliever Medication Use
|
-0.51 Number of inhalations
Interval -0.72 to -0.31
|
-0.22 Number of inhalations
Interval -0.43 to -0.01
|
-0.38 Number of inhalations
Interval -0.58 to -0.17
|
-0.39 Number of inhalations
Interval -0.59 to -0.18
|
-0.37 Number of inhalations
Interval -0.58 to -0.17
|
-0.37 Number of inhalations
Interval -0.58 to -0.17
|
-0.35 Number of inhalations
Interval -0.56 to -0.15
|
Adverse Events
AZD1981 400 mg
AZD1981 200 mg
AZD1981 100 mg
AZD1981 80 mg
AZD1981 40 mg
AZD1981 10 mg
Placebo
Serious adverse events
| Measure |
AZD1981 400 mg
n=164 participants at risk
AZD1981 400 mg twice daily
|
AZD1981 200 mg
n=159 participants at risk
AZD1981 200 mg once daily
|
AZD1981 100 mg
n=164 participants at risk
AZD1981 100 mg twice daily
|
AZD1981 80 mg
n=164 participants at risk
AZD1981 80 mg once daily
|
AZD1981 40 mg
n=163 participants at risk
AZD1981 40 mg twice daily
|
AZD1981 10 mg
n=163 participants at risk
AZD1981 10 mg twice daily
|
Placebo
n=163 participants at risk
Placebo
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Epilepsy
|
0.00%
0/164
|
0.00%
0/159
|
0.61%
1/164
|
0.00%
0/164
|
0.00%
0/163
|
0.00%
0/163
|
0.00%
0/163
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/164
|
0.63%
1/159
|
0.00%
0/164
|
0.00%
0/164
|
0.00%
0/163
|
0.00%
0/163
|
0.00%
0/163
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/164
|
0.00%
0/159
|
0.61%
1/164
|
0.00%
0/164
|
0.00%
0/163
|
0.00%
0/163
|
0.00%
0/163
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/164
|
0.00%
0/159
|
0.00%
0/164
|
0.61%
1/164
|
0.00%
0/163
|
0.00%
0/163
|
0.00%
0/163
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/164
|
0.00%
0/159
|
0.00%
0/164
|
0.00%
0/164
|
0.00%
0/163
|
0.00%
0/163
|
0.61%
1/163
|
|
Nervous system disorders
Syncope
|
0.00%
0/164
|
0.00%
0/159
|
0.61%
1/164
|
0.00%
0/164
|
0.00%
0/163
|
0.00%
0/163
|
0.00%
0/163
|
|
Vascular disorders
Vasculitis
|
0.00%
0/164
|
0.63%
1/159
|
0.00%
0/164
|
0.00%
0/164
|
0.00%
0/163
|
0.00%
0/163
|
0.00%
0/163
|
Other adverse events
| Measure |
AZD1981 400 mg
n=164 participants at risk
AZD1981 400 mg twice daily
|
AZD1981 200 mg
n=159 participants at risk
AZD1981 200 mg once daily
|
AZD1981 100 mg
n=164 participants at risk
AZD1981 100 mg twice daily
|
AZD1981 80 mg
n=164 participants at risk
AZD1981 80 mg once daily
|
AZD1981 40 mg
n=163 participants at risk
AZD1981 40 mg twice daily
|
AZD1981 10 mg
n=163 participants at risk
AZD1981 10 mg twice daily
|
Placebo
n=163 participants at risk
Placebo
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.4%
4/164
|
6.3%
10/159
|
4.3%
7/164
|
5.5%
9/164
|
3.1%
5/163
|
6.1%
10/163
|
3.7%
6/163
|
|
Infections and infestations
Bronchitis
|
0.61%
1/164
|
2.5%
4/159
|
1.2%
2/164
|
0.61%
1/164
|
3.1%
5/163
|
3.1%
5/163
|
3.1%
5/163
|
|
Infections and infestations
Pharyngitis
|
1.2%
2/164
|
1.3%
2/159
|
2.4%
4/164
|
2.4%
4/164
|
1.8%
3/163
|
1.8%
3/163
|
0.61%
1/163
|
|
Infections and infestations
Influenza
|
0.61%
1/164
|
0.00%
0/159
|
0.00%
0/164
|
1.2%
2/164
|
1.8%
3/163
|
3.1%
5/163
|
2.5%
4/163
|
|
Infections and infestations
Respiratory Tract Infection
|
0.61%
1/164
|
0.63%
1/159
|
0.61%
1/164
|
0.00%
0/164
|
0.61%
1/163
|
3.1%
5/163
|
1.2%
2/163
|
|
Nervous system disorders
Headache
|
1.2%
2/164
|
4.4%
7/159
|
4.3%
7/164
|
2.4%
4/164
|
1.8%
3/163
|
1.2%
2/163
|
1.2%
2/163
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.2%
2/164
|
0.00%
0/159
|
2.4%
4/164
|
1.8%
3/164
|
1.2%
2/163
|
2.5%
4/163
|
1.8%
3/163
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/164
|
0.00%
0/159
|
0.61%
1/164
|
0.00%
0/164
|
0.61%
1/163
|
2.5%
4/163
|
0.00%
0/163
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60