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Effect of Tiotropium on Inflammation and Exacerbations in COPD

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ClinicalTrials.gov Identifier: NCT00405236
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : November 29, 2006
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Royal Free and University College Medical School

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: tiotropium Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : October 2002
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. sputum IL-6

Secondary Outcome Measures :
  1. sputum IL-8
  2. sputum MPO
  3. serum IL-6
  4. serum CRP
  5. exacerbation frequency
  6. FEV1
  7. FVC


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405236


Locations
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United Kingdom
London Chest Hospital
London, United Kingdom
Sponsors and Collaborators
Royal Free and University College Medical School
Boehringer Ingelheim
Investigators
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Principal Investigator: Jadwiga A Wedzicha, MD Academic Unit of Respiratory Medicine, Royal Free and University College Medical School
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ClinicalTrials.gov Identifier: NCT00405236    
Other Study ID Numbers: 205.270
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: November 29, 2006
Last Verified: November 2006
Keywords provided by Royal Free and University College Medical School:
inflammation
exacerbations
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action