Moderate to Severe COPD Clinical Trial
— ColumbusOfficial title:
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)
The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease
| Status | Completed |
| Enrollment | 118 |
| Est. completion date | December 2008 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Research Site | Pleven | |
| Bulgaria | Research Site | Russe | |
| Bulgaria | Research Site | Sofia | |
| Bulgaria | Research Site | Varna | |
| Denmark | Research Site | Arhus C | |
| Denmark | Research Site | Hellerup | |
| Denmark | Research Site | Hvidovre | |
| Denmark | Research Site | Vaerlose | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Ostrow Wielkopolski | |
| Poland | Research Site | Przemysl | |
| Poland | Research Site | Rzeszow | |
| Slovakia | Research Site | Bojnice | |
| Slovakia | Research Site | Liptovsky Hradok | |
| Slovakia | Research Site | Poprad | |
| Slovakia | Research Site | Spisska Nova Ves | |
| Slovakia | Research Site | Zilina | |
| Sweden | Research Site | Lund | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Bulgaria, Denmark, Poland, Slovakia, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | FEV1 | Mean change in FEV1 from baseline to Week 4 (last measurement post dose used, if data missing) | Baseline and Week 4 | No |
| Primary | 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 | No |
| Secondary | Forced Vital Capacity | Mean change in FVC from baseline to Week 4 (last measurement post dose used, if data missing) | Baseline and Week 4 | No |
| Secondary | Slow Vital Capacity | Mean change in SVC from baseline to Week 4 (last measurement post dose used, if data missing) | Baseline and Week 4 | No |
| Secondary | Inspiratory Capacity | Mean change in IC from baseline to Week 4 (last measurement post dose used, if data missing) | Baseline and Week 4 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Adverse Event | The number of participants that experienced at least one adverse event. | Up to 4 Weeks | No |