Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

Official Title
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A 4 Week Double-blind, Placebo-controlled, Randomized, Parallel Group Phase IIa Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Moderate to Severe COPD

Intervention / Treatment
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* Drug: AZD1981
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FEV1 between 30 and 80% of predicted normal value post-bronchodilator (GOLD stages 2 and 3) Clinical diagnosis of COPD Exclusion Criteria: Other clinically relevant disease or disorders Exacerbation of COPD within 30 days

Ages Eligible for Study
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Minimum Age: 40 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<br>AZD1981 Oral tablet, twice daily | Drug: AZD1981<br>* Oral tablet, twice daily<br>|
| Placebo Comparator: Placebo<br>Placebo Oral tablet, twice daily | Drug: Placebo<br>* Placebo Oral tablet, twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 | Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing) | Baseline and Week 4 | 
| Clinical COPD Questionnaire | Mean change in Total CCQ from baseline to Week 4 (last measurement post dose used, if data missing). Scores for total CCQ range from 0 (low symptoms) to 6 (high symptoms). | Baseline and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Vital Capacity | Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing) | Baseline and Week 4 | 
| Slow Vital Capacity | Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing) | Baseline and Week 4 | 
| Inspiratory Capacity | Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing) | Baseline and Week 4 | 
| FEF25%-75% | Mean change in FEF25%-75% (forced expiratory flow between 25% and 75% of the FVC) from baseline to Week 4 (last measurement post dose used, if data missing) | Baseline and Week 4 | 
| COPD Symptom Sleep Score | Mean change in COPD symptom sleep score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sleep score range from 0 (no symptoms) to 4 (no sleep). | Baseline and 4-week treatment period average | 
| COPD Symptom Breathing Score | Mean change in COPD symptom breathing score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom breathing score range from 0 (none) to 4 (severe). | Baseline and 4-week treatment period average | 
| COPD Symptom Cough Score | Mean change in COPD symptom cough score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom cough score range from 0 (none) to 4 (almost constant). | Baseline and 4-week treatment period average | 
| COPD Symptom Sputum Score | Mean change in COPD symptom sputum score from baseline to treatment period average (calculated using all available data after randomisation for each patient). Scores for COPD symptom sputum score range from 0 (none) to 4 (severe). | Baseline and 4-week treatment period average | 
| PEF (Peak Expiratory Flow) Morning | Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient). | Baseline and 4-week treatment period average | 
| PEF (Peak Expiratory Flow) Evening | Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient). | Baseline and 4-week treatment period average | 
| Total Use of Reliever | Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient). | Baseline and 4-week treatment period average | 
| Adverse Event | The number of participants that experienced at least one adverse event. | Up to 4 Weeks | 

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