Effect of Tiotropium on Inflammation and Exacerbations in COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
tiotropium
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring inflammation, exacerbations
Eligibility 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
Sites / Locations
- London Chest Hospital
Outcomes
Primary Outcome Measures
sputum IL-6
Secondary Outcome Measures
sputum IL-8
sputum MPO
serum IL-6
serum CRP
exacerbation frequency
FEV1
FVC
Full Information
NCT ID
NCT00405236
First Posted
November 27, 2006
Last Updated
November 27, 2006
Sponsor
Royal Free and University College Medical School
Collaborators
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00405236
Brief Title
Effect of Tiotropium on Inflammation and Exacerbations in COPD
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 Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Free and University College Medical School
Collaborators
Boehringer Ingelheim
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
inflammation, exacerbations
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
220 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tiotropium
Primary Outcome Measure Information:
Title
sputum IL-6
Secondary Outcome Measure Information:
Title
sputum IL-8
Title
sputum MPO
Title
serum IL-6
Title
serum CRP
Title
exacerbation frequency
Title
FEV1
Title
FVC
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jadwiga A Wedzicha, MD
Organizational Affiliation
Academic Unit of Respiratory Medicine, Royal Free and University College Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Chest Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Effect of Tiotropium on Inflammation and Exacerbations in COPD
We'll reach out to this number within 24 hrs