Study to Evaluate the Effects of Tiotropium Bromide on COPD During Exercise - Full Text View

Sponsors and Collaborators:	Hamilton Health Sciences Boehringer Ingelheim Pharmaceuticals
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00412204

Purpose

The purpose of this study is to determine the effect of treatment with tiotropium bromide on efficiency of gas exchange and exercise performance in COPD subjects during exercise.

Condition	Intervention	Phase
COPD	Drug: tiotropium bromide Other: Placebo	Phase IV

MedlinePlus related topics: Exercise and Physical Fitness Gas

Drug Information available for: Tiotropium Tiotropium bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effects of Tiotropium Bromide on Gas Exchange in Subjects With COPD During Exercise

Further study details as provided by McMaster University:

Primary Outcome Measures:

Efficiency of gas exchange Ve/VO2 and Ve/VCO2 before and after 3 weeks treatment with tiotropium compared to placebo. [ Time Frame: Before and after 3 weeks treatment with tiotropium compared to placebo. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intensity of dyspnea [ Time Frame: Before and after 3 weeks treatment with tiotropium compared to placebo. ] [ Designated as safety issue: No ]
Effort during incremental and steady state exercise [ Time Frame: Before and after 3 weeks treatment with tiotropium compared to placebo. ] [ Designated as safety issue: No ]
Exercise endurance capacity [ Time Frame: Before and after 3 weeks treatment with tiotropium compared to placebo. ] [ Designated as safety issue: No ]
Dyspnea and leg effort [ Time Frame: Before and after 3 weeks treatment with tiotropium compared to placebo. ] [ Designated as safety issue: No ]
Ventilatory capacity [ Time Frame: Before and after 3 weeks treatment with tiotropium compared to placebo. ] [ Designated as safety issue: No ]
Alveolar volume [ Time Frame: Before and after 3 weeks treatment with tiotropium compared to placebo. ] [ Designated as safety issue: No ]
Kco [ Time Frame: Before and after 3 weeks treatment with tiotropium compared to placebo. ] [ Designated as safety issue: No ]
Cardiac output at rest and during steady state exercise before and after 3 weeks treatment with tiotropium compared to placebo. [ Time Frame: Before and after 3 weeks treatment with tiotropium compared to placebo. ] [ Designated as safety issue: No ]
Ventilation/perfusion before and after 3 weeks treatment with tiotropium compared to placebo [ Time Frame: Before and after 3 weeks treatment with tiotropium compared to placebo. ] [ Designated as safety issue: No ]
Ventilation during incremental and steady state exercise before and after 3 weeks treatment with tiotropium compared to placebo. [ Time Frame: Before and after 3 weeks treatment with tiotropium compared to placebo. ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	June 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Tiotropium	Drug: tiotropium bromide Subjects will be randomized to treatment with tiotropium or placebo. Double-blind medication will be dispensed in HandiHalers to be taken once daily in the morning for 22 days.
2: Placebo Comparator Placebo	Other: Placebo Subjects will be randomized to treatment with tiotropium or placebo. Double-blind medication will be dispensed in HandiHalers to be taken once daily in the morning for 22 days.

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Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be current or ex-smokers with a cigarette smoking history of > 10 pack years.
All patients must have a diagnosis of COPD.
Patients maintained on a daily dose of inhaled corticosteroids need to be at a constant dose at 4 weeks prior to study entry.

Exclusion Criteria:

Patients with significant diseases other than COPD.
Patients with a history of a recent (i.e. six months or less) myocardial infarction.
Patients with unstable or life threatening cardiac arrhythmias including any patient with a newly diagnosed, clinically relevant arrhythmia on the ECG performed on Visit 1.
Patients who have been hospitalized for heart failure (NYHA class III or IV) within the past year.
Patients with a history of life threatening pulmonary obstruction, or history of cystic fibrosis or clinically evident bronchiectasis.
Patients who have undergone thoracotomy with pulmonary resection.
Patients with any respiratory infection or exacerbation in the six weeks prior to Visit 1.
Patients who regularly use daytime oxygen therapy for more than one hour per day and who in the investigator's opinion, will be unable to abstain from the use of oxygen therapy during testing.
Patients who are currently in a pulmonary rehabilitation program or who have completed a pulmonary rehabilitation program within four weeks of Visit 1.
Patients with known active tuberculosis.
Patients with a history of cancer within the past five years.
Pregnant or breastfeeding women or women of childbearing potential not using a medically approved means of contraception.
Patients with known hypersensitivity to anti-cholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
Patients with a history of significant alcohol or drug abuse in the previous year.
Patients with have taken an investigational drug within 30 days or 6 half lives (whichever is greater) prior to Visit 1.
Patients using oral corticosteroid medication and unstable doses (i.e. less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg prednisone per day or 20 mg every other day.
Patients who use rescue medication (Salbutamol) more than 8 puffs/day.
Patients who have used tiotropium (Spiriva) within 4 weeks prior to Visit 1.
Patients who have frequent exacerbations which could be expected to interfere with participation in the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412204

Contacts

Contact: Gail Gauvreau, PhD	905-525-9140 ext 22791	gauvreau@mcmaster.ca
Contact: Keiran Killian, MD	905-521-2100 ext 76228	killiank@mcmaster.ca

Locations

Canada, Ontario
Hamilton Health Sciences McMaster University	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Principal Investigator: Gail Gauvreau, PhD

Sponsors and Collaborators

Hamilton Health Sciences

Boehringer Ingelheim Pharmaceuticals

Investigators

Principal Investigator:	Gail Gauvreau, PhD	McMaster University
Study Director:	Keiran Killian, MD	McMaster University

More Information

Responsible Party:	McMaster University ( Gail Gauvreau )
Study ID Numbers:	205.371
Study First Received:	December 14, 2006
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00412204
Health Authority:	Canada: Health Canada

Keywords provided by McMaster University:

double-blind
placebo-controlled
crossover
effects of tiotropium bromide

gas exchange
Chronic Obstructive Pulmonary Disease
exercise.

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides

Lung Diseases
Tiotropium
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Parasympatholytics
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
Central Nervous System Agents
Bronchodilator Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009