Effect of Tiotropium on Inflammation and Exacerbations in COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-01-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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inflammation exacerbations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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tiotropium

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jadwiga A Wedzicha, MD

Role: PRINCIPAL_INVESTIGATOR

Academic Unit of Respiratory Medicine, Royal Free and University College Medical School

Locations

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London Chest Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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205.270

Identifier Type: -

Identifier Source: org_study_id