Study to Evaluate the Effects of Tiotropium Bromide on Chronic Obstructive Pulmonary Disease (COPD) During Exercise

NCT00412204 | Completed Phase 4

• 1 other identifier: 205.371
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

COPD

Keywords

double-blind; placebo-controlled; crossover; effects of tiotropium bromide; gas exchange; Chronic Obstructive Pulmonary Disease; exercise.

Outcome Measures

Primary Outcomes (1)

• Efficiency of gas exchange Ve/VO2 and Ve/VCO2 before and after 3 weeks treatment with tiotropium compared to placebo.

  Before and after 3 weeks treatment with tiotropium compared to placebo.

Secondary Outcomes (10)

• Intensity of dyspnea

  Before and after 3 weeks treatment with tiotropium compared to placebo.

• Effort during incremental and steady state exercise

  Before and after 3 weeks treatment with tiotropium compared to placebo.

• Exercise endurance capacity

  Before and after 3 weeks treatment with tiotropium compared to placebo.

• Dyspnea and leg effort

  Before and after 3 weeks treatment with tiotropium compared to placebo.

• Ventilatory capacity

  Before and after 3 weeks treatment with tiotropium compared to placebo.

Study Arms (2)

1

ACTIVE COMPARATOR

Tiotropium

Drug: tiotropium bromide

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

tiotropium bromide DRUG

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.

Also known as: tiotropium bromide (Spiriva)

1

Placebo OTHER

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Boehringer Ingelheim: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Gail Gauvreau, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Keiran Killian, MD

  McMaster University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2006
• First Posted: December 15, 2006
• Study Start: June 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: October 21, 2009

Record last verified: 2009-10