One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids.

Official Title
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A Double-blind, Randomised, Parallel Group, Multicentre Phase IIb, Placebo-Controlled, 1 Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids

Conditions
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Asthma

Intervention / Treatment
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* Drug: AZD1981
* Drug: AZD1981
* Drug: AZD1981
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Other clinically relevant disease or disorders History of smoking of more than 10 pack years Respiratory infection within 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD1981 50 mg<br>AZD1981 50 mg Twice Daily (Bid) | Drug: AZD1981<br>* Oral tablet, 50 mg twice daily<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |
| Experimental: AZD1981 400 mg<br>AZD1981 400 mg Twice Daily (Bid) | Drug: AZD1981<br>* Oral tablet, 400 mg twice daily<br>|
| Experimental: AZD1981 1000 mg<br>AZD1981 1000 mg Twice Daily (Bid) | Drug: AZD1981<br>* Oral tablet, 1000 mg twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning Peak Expiratory Flow (mPEF) | Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period) | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evening Peak Expiratory Flow (ePEF) | Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period) | Week 4 | 
| Morning Forced Expiratory Volume in 1 Second (mFEV1) | Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period) | Week 4 | 
| Evening Forced Expiratory Volume in 1 Second (eFEV1) | Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period) | Week 4 | 
| Total Use of Reliever | Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period) | Week 4 | 
| 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). | Week 4 | 
| 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). | Week 4 | 
| Awakenings | Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period) | Week 4 | 
| 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. | Week 4 | 
| 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. | Week 4 | 
| 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. | Week 4 | 
| Forced Expiratory Volume in 1 Second (FEV1) at the Clinic | Mean FEV1 during the treatment period (mean value at Week 4) | Week 4 | 
| Forced Vital Capacity (FVC) at the Clinic | Mean FVC during the treatment period (mean value at Week 4) | Week 4 | 
| 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). | Week 4 | 
| Adverse Event (AE) | Number of patients reporting at least one event | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma