Effect of Tiotropium on Inflammation and Exacerbations in COPD
Information source: Royal Free and University College Medical School
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: tiotropium (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Royal Free and University College Medical School Official(s) and/or principal investigator(s): Jadwiga A Wedzicha, MD, Principal Investigator, Affiliation: Academic Unit of Respiratory Medicine, Royal Free and University College Medical School
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: sputum IL-6
Secondary outcome: sputum IL-8sputum MPO serum IL-6 serum CRP exacerbation frequency FEV1 FVC
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
London Chest Hospital, London, United Kingdom
Additional Information
Starting date: October 2002
Last updated: November 27, 2006
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