Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Changes in Inflammatory Markers in Induced Sputum Following Treatment With Tiotropium Inhalation Capsules 18mcg Once Daily in Patients With Chronic Obstructive Pulmonary Disease
Patients with COPD experience exacerbations that are a major cause of morbidity. Exacerbations are associated with increased airway and systemic inflammation and those experiencing frequent exacerbations demonstrate increased inflammation in the stable state. Tiotropium has been shown to reduce exacerbation frequency and it might be postulated that this is due to a reduction in inflammation. The study will compare airway inflammation and exacerbation frequency in patients with COPD on tiotropium or placebo.
Status | Completed |
Enrollment | 220 |
Est. completion date | January 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - diagnosis of COPD, - FEV1 < 80% predicted, - minimum 10 pack year smoking history Exclusion Criteria: - asthma, - atopic disease, - eosinophilia, - history of malignancy, - history of clinically significant pulmonary disease |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | London Chest Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Royal Free and University College Medical School | Boehringer Ingelheim |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | sputum IL-6 | |||
Secondary | sputum IL-8 | |||
Secondary | sputum MPO | |||
Secondary | serum IL-6 | |||
Secondary | serum CRP | |||
Secondary | exacerbation frequency | |||
Secondary | FEV1 | |||
Secondary | FVC |
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