Effect of Tiotropium on Inflammation and Exacerbations in COPD - Full Text View

Sponsors and Collaborators:	Royal Free and University College Medical School Boehringer Ingelheim Pharmaceuticals
Information provided by:	Royal Free and University College Medical School
ClinicalTrials.gov Identifier:	NCT00405236

Purpose

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	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: tiotropium	Phase IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium Tiotropium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Royal Free and University College Medical School:

Primary Outcome Measures:

sputum IL-6

Secondary Outcome Measures:

sputum IL-8
sputum MPO
serum IL-6
serum CRP
exacerbation frequency
FEV1
FVC

Estimated Enrollment:	220
Study Start Date:	October 2002
Estimated Study Completion Date:	January 2005

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

Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405236

Locations

United Kingdom
London Chest Hospital
London, United Kingdom

Sponsors and Collaborators

Royal Free and University College Medical School

Boehringer Ingelheim Pharmaceuticals

Investigators

Principal Investigator:

Jadwiga A Wedzicha, MD

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

More Information

Study ID Numbers:	205.270
Study First Received:	November 27, 2006
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00405236
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Royal Free and University College Medical School:

inflammation
exacerbations

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Tiotropium
Inflammation
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Parasympatholytics
Respiratory System Agents
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Cholinergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009