Trial Outcomes & Findings for One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids (NCT NCT00758589)
NCT ID: NCT00758589
Last Updated: 2014-02-26
Results Overview
Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)
COMPLETED
PHASE2
368 participants
Week 4
2014-02-26
Participant Flow
510 patients enrolled, 368 were allocated to treatment and 350 completed the study. First patient entered the study on 16 September 2008 and the last patient finished the study on 13 July 2009.
Participant milestones
| Measure |
AZD1981 50 mg Twice Daily (Bid)
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
95
|
90
|
92
|
91
|
|
Overall Study
COMPLETED
|
92
|
87
|
86
|
85
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
6
|
6
|
Reasons for withdrawal
| Measure |
AZD1981 50 mg Twice Daily (Bid)
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
1
|
|
Overall Study
Palm stopped to work
|
0
|
0
|
0
|
1
|
Baseline Characteristics
One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids
Baseline characteristics by cohort
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=91 Participants
placebo oral tablet, twice daily
|
Total
n=368 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.3 Years
n=5 Participants
|
43 Years
n=7 Participants
|
43.5 Years
n=5 Participants
|
45.7 Years
n=4 Participants
|
44.35 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
255 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=89 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=90 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Morning Peak Expiratory Flow (mPEF)
|
346.42 L/min
Standard Deviation 132.70 • Interval -245.0 to 334.0
|
362.54 L/min
Standard Deviation 134.69 • Interval -131.0 to 213.0
|
352.87 L/min
Standard Deviation 124.22 • Interval -158.0 to 219.0
|
329.75 L/min
Standard Deviation 140.14 • Interval -283.0 to 158.0
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period)
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=89 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=91 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Evening Peak Expiratory Flow (ePEF)
|
359.83 L/min
Standard Deviation 129.23 • Interval -192.0 to 315.0
|
378.98 L/min
Standard Deviation 134.54 • Interval -179.0 to 262.0
|
368.70 L/min
Standard Deviation 124.08 • Interval -149.0 to 225.0
|
348.87 L/min
Standard Deviation 142.92 • Interval -202.0 to 197.0
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=67 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=63 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=71 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=71 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Morning Forced Expiratory Volume in 1 Second (mFEV1)
|
2.45 L
Standard Deviation 0.99 • Interval -1.24 to 1.8
|
2.65 L
Standard Deviation 1.03 • Interval -1.41 to 1.04
|
2.53 L
Standard Deviation 0.97 • Interval -0.503 to 0.843
|
2.31 L
Standard Deviation 1.05 • Interval -2.21 to 1.12
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=66 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=66 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=73 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=72 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Evening Forced Expiratory Volume in 1 Second (eFEV1)
|
2.47 L
Standard Deviation 0.95 • Interval -0.834 to 1.17
|
2.72 L
Standard Deviation 1.02 • Interval -1.56 to 1.2
|
2.63 L
Standard Deviation 0.98 • Interval -0.765 to 2.03
|
2.43 L
Standard Deviation 1.06 • Interval -1.46 to 1.66
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period)
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=91 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Total Use of Reliever
|
2.870 Number of inhalations per day
Standard Deviation 2.475 • Interval -4.8 to 5.34
|
2.640 Number of inhalations per day
Standard Deviation 2.303 • Interval -6.36 to 6.59
|
2.569 Number of inhalations per day
Standard Deviation 2.210 • Interval -8.3 to 3.23
|
2.855 Number of inhalations per day
Standard Deviation 2.430 • Interval -6.79 to 2.84
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean night-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=91 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Night-time Asthma Symptom Score
|
0.998 Scores on a scale
Standard Deviation 0.633 • Interval -2.8 to 0.733
|
0.881 Scores on a scale
Standard Deviation 0.543 • Interval -1.36 to 0.786
|
0.912 Scores on a scale
Standard Deviation 0.594 • Interval -1.83 to 0.655
|
1.008 Scores on a scale
Standard Deviation 0.614 • Interval -2.12 to 0.714
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean day-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=91 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Day-time Asthma Symptom Score
|
1.037 Scores on a scale
Standard Deviation 0.609 • Interval -2.8 to 0.85
|
0.933 Scores on a scale
Standard Deviation 0.556 • Interval -1.0 to 1.04
|
0.995 Scores on a scale
Standard Deviation 0.552 • Interval -2.2 to 1.25
|
1.105 Scores on a scale
Standard Deviation 0.645 • Interval -2.0 to 1.62
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period)
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=91 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Awakenings
|
38.59 Percentage of days
Standard Deviation 40.25 • Interval -100.0 to 44.4
|
33.18 Percentage of days
Standard Deviation 38.93 • Interval -84.6 to 100.0
|
33.34 Percentage of days
Standard Deviation 37.68 • Interval -92.3 to 60.0
|
37.32 Percentage of days
Standard Deviation 39.51 • Interval -100.0 to 58.6
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean percentage of asthma control days during the treatment period (mean of the last 2 weeks of the treatment period). An asthma control day is defined as a symptom-free day with no use of reliever medication during day and night. A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=91 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Asthma Control Day
|
10.78 Percentage of days
Standard Deviation 25.79 • Interval -12.5 to 100.0
|
7.48 Percentage of days
Standard Deviation 20.71 • Interval -20.0 to 100.0
|
13.23 Percentage of days
Standard Deviation 26.24 • Interval -38.3 to 100.0
|
10.08 Percentage of days
Standard Deviation 22.36 • Interval -1.67 to 100.0
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean percentage of symptom free days during the treatment period (mean of the last 2 weeks of the treatment period). A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=91 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Symptom Free Day
|
17.33 Percentage of days
Standard Deviation 32.16 • Interval -49.2 to 100.0
|
13.95 Percentage of days
Standard Deviation 28.35 • Interval -52.3 to 100.0
|
15.56 Percentage of days
Standard Deviation 28.51 • Interval -72.3 to 100.0
|
14.31 Percentage of days
Standard Deviation 26.28 • Interval -23.8 to 100.0
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean percentage of reliever free days during the treatment period (mean of the last 2 weeks of the treatment period). A reliever free day is defined as a day and a night with no use of as-needed medication.
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=91 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Reliever Free Day
|
22.59 Percentage of days
Standard Deviation 34.57 • Interval -16.9 to 100.0
|
20.60 Percentage of days
Standard Deviation 32.01 • Interval -30.0 to 100.0
|
24.13 Percentage of days
Standard Deviation 32.12 • Interval -50.0 to 100.0
|
20.94 Percentage of days
Standard Deviation 32.97 • Interval -23.6 to 100.0
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean FEV1 during the treatment period (mean value at Week 4)
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=93 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=88 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) at the Clinic
|
2.653 L
Standard Deviation 1.051 • Interval -0.76 to 2.02
|
2.739 L
Standard Deviation 1.028 • Interval -0.73 to 2.16
|
2.628 L
Standard Deviation 1.057 • Interval -2.46 to 2.04
|
2.400 L
Standard Deviation 0.945 • Interval -0.74 to 1.26
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean FVC during the treatment period (mean value at Week 4)
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=93 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=88 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Forced Vital Capacity (FVC) at the Clinic
|
3.704 L
Standard Deviation 1.268 • Interval -1.48 to 2.21
|
3.892 L
Standard Deviation 1.295 • Interval -0.98 to 2.3
|
3.546 L
Standard Deviation 1.257 • Interval -1.03 to 2.68
|
3.563 L
Standard Deviation 1.215 • Interval -0.99 to 2.02
|
SECONDARY outcome
Timeframe: Week 4Population: The efficacy analysis is based on 368 total randomized patients with available data. However, not all patients will have valid, non-missing values for a given outcome measure.
Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control).
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=89 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=86 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=85 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Asthma Control Questionnaire 5 Items (ACQ5)
|
1.69 Scores on a scale
Full Range -2.40 • Interval 0.0 to 4.0
|
1.58 Scores on a scale
Full Range -2.40 • Interval 0.0 to 3.8
|
1.64 Scores on a scale
Full Range -3.20 • Interval 0.0 to 4.6
|
1.91 Scores on a scale
Full Range -2.60 • Interval 0.0 to 4.2
|
SECONDARY outcome
Timeframe: 4 weeksNumber of patients reporting at least one event
Outcome measures
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 Participants
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 Participants
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 Participants
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=91 Participants
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Adverse Event (AE)
|
28 Participants
|
22 Participants
|
33 Participants
|
24 Participants
|
Adverse Events
AZD1981 50 mg Twice Daily (Bid)
AZD1981 400 mg Twice Daily (Bid)
AZD1981 1000 mg Twice Daily (Bid)
Placebo
Serious adverse events
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 participants at risk
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 participants at risk
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 participants at risk
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=91 participants at risk
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/95
|
0.00%
0/90
|
1.1%
1/92
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/95
|
0.00%
0/90
|
0.00%
0/92
|
1.1%
1/91
|
Other adverse events
| Measure |
AZD1981 50 mg Twice Daily (Bid)
n=95 participants at risk
AZD1981 oral tablet 50 mg, twice daily
|
AZD1981 400 mg Twice Daily (Bid)
n=90 participants at risk
AZD1981 oral tablet 400 mg, twice daily
|
AZD1981 1000 mg Twice Daily (Bid)
n=92 participants at risk
AZD1981 oral tablet 1000 mg, twice daily
|
Placebo
n=91 participants at risk
placebo oral tablet, twice daily
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/95
|
2.2%
2/90
|
5.4%
5/92
|
3.3%
3/91
|
|
Nervous system disorders
Headache
|
2.1%
2/95
|
4.4%
4/90
|
3.3%
3/92
|
2.2%
2/91
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.1%
2/95
|
1.1%
1/90
|
3.3%
3/92
|
4.4%
4/91
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60