Effect of Tiotropium on Inflammation and Exacerbations in COPD

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Free and University College Medical School
• Collaborator: Boehringer Ingelheim
• Treatments: Tiotropium Bromide

Criteria

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