Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— TOPOfficial title:
A 4-week Double-blind, Placebo-controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
Status | Completed |
Enrollment | 65 |
Est. completion date | August 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of COPD, with symptoms for more than 1 year - Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year) - Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator Exclusion Criteria: - Clinical suspicion of active tuberculosis - Any current clinically significant respiratory tract disorder other than COPD - History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina |
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 |
---|---|---|---|
Denmark | Research Site | Hvidovre | |
Denmark | Research Site | København Nv | |
Denmark | Research Site | Odense C | |
Finland | Research Site | Helsinki | |
Finland | Research Site | Preitilä | |
Finland | Research Site | Tampere | |
Netherlands | Research Site | Breda | |
Netherlands | Research Site | Groningen | |
Norway | Research Site | Elverum | |
Norway | Research Site | Oslo | |
Norway | Research Site | Trondheim | |
Sweden | Research Site | Lund |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Denmark, Finland, Netherlands, Norway, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients Experiencing Adverse Events | Number of patients who had an Adverse Event | At all study visits | No |
Secondary | Forced Expiratory Volume 1 (FEV1) | Change in (FEV1) from baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment | No |
Secondary | Forced Vital Capacity (FVC) | Change in FVC from baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment | No |
Secondary | Vital Capacity (VC) | Change in VC from baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment | No |
Secondary | Inspiratory Capacity (IC) | Change from IC baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment | No |
Secondary | Forced Expiratory Flow (FEF) 25%-75% | Change in FEF from baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment | No |
Secondary | Peak Expiratory Flow (PEF) Morning | Change from average during run-in to average during treatment | Daily during run-in and treatment | No |
Secondary | Peak Expiratory Flow (PEF) Evening | Change in PEF from average during run-in to average during treatment | Daily during run-in and treatment | No |
Secondary | The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total | Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited) | Before treatment and after 1, 2, 3 and 4 weeks of treatment | No |
Secondary | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe). | Daily during run-in and treatment | No |
Secondary | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe). | Daily during run-in and treatment | No |
Secondary | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe). | Daily during run-in and treatment | No |
Secondary | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score | Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe). | Daily during run-in and treatment | No |
Secondary | 6-minute Walk Test | Change from baseline to end of treatment | Before treatment and after 4 weeks of treatment | No |
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