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OpenTrials
Completed

NCT Number: NCT00405236

Effect of Tiotropium on Inflammation and Exacerbations in COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Inflammation Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

London Chest Hospital

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tiotropium

Drug

Primary outcomes

  1. sputum IL-6

Secondary outcomes

  1. sputum IL-8

  2. sputum MPO

  3. serum IL-6

  4. serum CRP

  5. exacerbation frequency

  6. FEV1

  7. FVC

Sponsors and collaborators

Lead sponsor

Royal Free and University College Medical School

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2005
First posted
Nov 29, 2006
Registry last updated
Nov 29, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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