One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids
- Conditions
- Asthma
- Interventions
- Drug: AZD1981Drug: Placebo
- Registration Number
- NCT00758589
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 368
- Six months history of asthma
- Daily use of inhaled glucocorticosteroids
- FEV1 40-85% of predicted normal
- Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator
- Other clinically relevant disease or disorders
- History of smoking of more than 10 pack years
- Respiratory infection within 30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZD1981 50 mg AZD1981 AZD1981 50 mg Twice Daily (Bid) Placebo Placebo Placebo AZD1981 400 mg AZD1981 AZD1981 400 mg Twice Daily (Bid) AZD1981 1000 mg AZD1981 AZD1981 1000 mg Twice Daily (Bid)
- Primary Outcome Measures
Name Time Method Morning Peak Expiratory Flow (mPEF) Week 4 Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)
- Secondary Outcome Measures
Name Time Method Evening Peak Expiratory Flow (ePEF) Week 4 Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period)
Morning Forced Expiratory Volume in 1 Second (mFEV1) Week 4 Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)
Evening Forced Expiratory Volume in 1 Second (eFEV1) Week 4 Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)
Total Use of Reliever Week 4 Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period)
Night-time Asthma Symptom Score Week 4 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).
Day-time Asthma Symptom Score Week 4 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).
Awakenings Week 4 Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period)
Asthma Control Day Week 4 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.
Symptom Free Day Week 4 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.
Reliever Free Day Week 4 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.
Forced Expiratory Volume in 1 Second (FEV1) at the Clinic Week 4 Mean FEV1 during the treatment period (mean value at Week 4)
Forced Vital Capacity (FVC) at the Clinic Week 4 Mean FVC during the treatment period (mean value at Week 4)
Asthma Control Questionnaire 5 Items (ACQ5) Week 4 Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control).
Adverse Event (AE) 4 weeks Number of patients reporting at least one event
Trial Locations
- Locations (1)
Research Site
🇵🇱Wroclaw, Poland