| Primary | Morning Peak Expiratory Flow (mPEF) | Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period) | 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. | Posted | | Mean | Standard Deviation | L/min | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| | Units | Counts |
|---|
| Participants | - OG00095
- OG00189
- OG00292
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000346.42± 132.70(-245 to 334)
- OG001362.54± 134.69(-131 to 213)
- OG002352.87± 124.22(-158 to 219)
|
|
| |
| Secondary | Evening Peak Expiratory Flow (ePEF) | Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period) | 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. | Posted | | Mean | Standard Deviation | L/min | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |
| Secondary | Morning Forced Expiratory Volume in 1 Second (mFEV1) | Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period) | 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. | Posted | | Mean | Standard Deviation | L | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |
| Secondary | Evening Forced Expiratory Volume in 1 Second (eFEV1) | Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period) | 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. | Posted | | Mean | Standard Deviation | L | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |
| Secondary | Total Use of Reliever | Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period) | 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. | Posted | | Mean | Standard Deviation | Number of inhalations per day | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |
| Secondary | Night-time Asthma Symptom Score | 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). | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |
| Secondary | Day-time Asthma Symptom Score | 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). | 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. | Posted | | Mean | Standard Deviation | Scores on a scale | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |
| Secondary | Awakenings | Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period) | 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. | Posted | | Mean | Standard Deviation | Percentage of days | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |
| Secondary | Asthma Control Day | 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. | 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. | Posted | | Mean | Standard Deviation | Percentage of days | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
|
| Secondary | Symptom Free Day | 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. | 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. | Posted | | Mean | Standard Deviation | Percentage of days | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |
| Secondary | Reliever Free Day | 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. | 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. | Posted | | Mean | Standard Deviation | Percentage of days | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) at the Clinic | Mean FEV1 during the treatment period (mean value at Week 4) | 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. | Posted | | Mean | Standard Deviation | L | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |
| Secondary | Forced Vital Capacity (FVC) at the Clinic | Mean FVC during the treatment period (mean value at Week 4) | 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. | Posted | | Mean | Standard Deviation | L | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |
| Secondary | Asthma Control Questionnaire 5 Items (ACQ5) | Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control). | 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. | Posted | | Mean | Full Range | Scores on a scale | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |
| Secondary | Adverse Event (AE) | Number of patients reporting at least one event | | Posted | | Number | | Participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | AZD1981 50 mg Twice Daily (Bid) | AZD1981 oral tablet 50 mg, twice daily | | OG001 | AZD1981 400 mg Twice Daily (Bid) | AZD1981 oral tablet 400 mg, twice daily | | OG002 | AZD1981 1000 mg Twice Daily (Bid) | AZD1981 oral tablet 1000 mg, twice daily | | OG003 | Placebo | placebo oral tablet, twice daily |
| |