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

Royal Free and University College Medical School1 site in 1 country220 target enrollmentOctober 2002

ConditionsChronic Obstructive Pulmonary Disease

Drugstiotropium

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Royal Free and University College Medical School
Enrollment: 220
Locations: 1
Primary Endpoint: sputum IL-6
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

Patients with COPD will be randomised to tiotropium or placebo in addition to their usual medication. They will be followed prospectively over 1 year and provide sputum for quantification of IL-6 and IL-8 at baseline and at 3 monthly intervals.Serum IL-6 will also be quantified at baseline and over the year. Changes in inflammatory markers will be assessed by analysis of area under the curve of log transformed data. Exacerbation frequency will be calculated from patient diary cards using a previously validated symptom-based exacerbation definition.

Registry

clinicaltrials.gov

Start Date

October 2002

End Date

January 2005

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel