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

Phase 2

Completed

• Conditions: Moderate to Severe COPD
• Interventions: Drug: Placebo; Drug: AZD1981

• Registration Number: NCT00690482
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-04
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2013-07-01
• Results First Submitted QC: 2013-10-11
• Status Verified: 2013-12
• Results First Posted: 2013-12-06
• Last Update Submitted: 2013-12-13
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• FEV1 between 30 and 80% of predicted normal value post-bronchodilator (GOLD stages 2 and 3)
• Clinical diagnosis of COPD

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Exclusion Criteria

• Other clinically relevant disease or disorders
• Exacerbation of COPD within 30 days

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Oral tablet, twice daily
AZD1981	AZD1981	AZD1981 Oral tablet, twice daily

Primary Outcome Measures

Name	Time	Method
Clinical COPD Questionnaire	Baseline and Week 4	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).
FEV1	Baseline and Week 4	Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing)

Secondary Outcome Measures

Name	Time	Method
Slow Vital Capacity	Baseline and Week 4	Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing)
FEF25%-75%	Baseline and Week 4	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)
COPD Symptom Sleep Score	Baseline and 4-week treatment period average	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).
Inspiratory Capacity	Baseline and Week 4	Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing)
COPD Symptom Breathing Score	Baseline and 4-week treatment period average	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).
COPD Symptom Cough Score	Baseline and 4-week treatment period average	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).
COPD Symptom Sputum Score	Baseline and 4-week treatment period average	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).
PEF (Peak Expiratory Flow) Morning	Baseline and 4-week treatment period average	Mean change in PEF morning from baseline to treatment period average (calculated using all available data after randomisation for each patient).
PEF (Peak Expiratory Flow) Evening	Baseline and 4-week treatment period average	Mean change in PEF evening from baseline to treatment period average (calculated using all available data after randomisation for each patient).
Total Use of Reliever	Baseline and 4-week treatment period average	Mean change in Total use of reliever from baseline to treatment period average (calculated using all available data after randomisation for each patient).
Forced Vital Capacity	Baseline and Week 4	Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing)
Adverse Event	Up to 4 Weeks	The number of participants that experienced at least one adverse event.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden