Effects of Tiotropium on Walking Capacity in Patients With COPD

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT01307189
First received: February 28, 2011
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

This study was designed to test the following hypothesis:

A) The acute and long-term (3 weeks) bronchodilator-induced changes in exercise tolerance and in the physiological response during the endurance shuttle walk will be greater with tiotropium compared to placebo in COPD patients.

B) Three weeks of bronchodilation will be associated with increase activity of daily living as evaluated using the London Chest Activity Daily Living scale.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Tiotropium
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Tiotropium on Walking Capacity in Patients With COPD

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Endurance time during an endurance shuttle walk [ Time Frame: acute response (2.5 hours) following the administration of the active and comparison drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the long-term bronchodilator-induced changes in exercise tolerance during the endurance shuttle walk [ Time Frame: three weeks ] [ Designated as safety issue: No ]
  • Evaluate the impact of long-term bronchodilation on activity of daily living evaluated using the London Chest Activity Daily Living scale [ Time Frame: three weeks ] [ Designated as safety issue: No ]
  • Cardio-respiratory responses during an endurance shutlle walk [ Time Frame: acute response following the administration of the study medication ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: April 2005
Study Completion Date: August 2010
Arms Assigned Interventions
Active Comparator: Tiotropium Drug: Tiotropium
Tiotropium diskus inhalation powder, 18ug, once daily
Other Name: Spiriva
Placebo Comparator: Placebo Drug: Placebo
Placebo diskus inhalation powder, once daily
Other Name: Placebo

Detailed Description:

Objectives:

The purpose of this study is to compare the acute bronchodilator-induced changes in exercise tolerance during the endurance shuttle walk between tiotropium and placebo in COPD patients. Also, it will evaluate the physiological response (VE, VO2, VCO2, and heart rate) during the endurance shuttle walk in patients with COPD patients. Finally, it will compare the long-term (3 weeks) bronchodilator-induced changes in exercise tolerance during the endurance shuttle walk between tiotropium and placebo in COPD patients and evaluate the impact of long-term (3 weeks) bronchodilation on activity of daily living evaluated using the London Chest Activity Daily Living scale.

Methods:

This will be a double-blind, randomized and parallel-group study. Due to the long action duration of tiotropium (up to 4 weeks), a cross-over design, as we used in our ipratropium versus placebo study, is not appropriate in the present study. The study will require five visits at the Centre de recherche de l'Hopital Laval. The first visit will include review of the consent form, pulmonary function testing, and a maximal incremental shuttle walk. The following two visits (Visit 2 and 3) will be used to familiarize the participants to the shuttle endurance walking test. Salbutamol and ipratropium bromide will be stopped 6 hours prior to these visits while the remaining medication allowed during the study period (see below) will be continued as prescribed. The goal of the familiarization will be to reduce the learning effect that typically occurs when an individual completes the same endurance test several times 3. On visit 4, patients will be randomized to receive one of the two treatments: placebo or tiotropium 18 ug (Spiriva) using the handihaler device. Pulmonary function testing will then be performed and the London Chest Activity Daily Living scale will be administered. Two hours following the inhalation of the first study dose, pulmonary function testing will be repeated and the patients will perform an endurance shuttle walk. They will be provided enough medication for the study duration and discharged. The same procedure as Visit 4 will be completed three weeks later, on visit 5.

Data analysis:

The main outcome will be endurance time at day 21. This variable will be compared between the two treatment arms using an unpaired t-test. The endurance time at day 0 will also be compared between the two treatment arms using the same procedure. The time course of the cardiorespiratory parameters and dyspnea over time will be compared between the two exercise modalities. Comparisons will be done using a repeated measure design (ANOVA). Significance level will be set at a p value of 0.05. The two familiarization endurance shuttle walk tests performed at day -10 and day -5 will be used to evaluate the test-retest variability of this procedure.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 50 years, smoking history > 10 packs/year, FEV1 < 70% of predicted and FEV1/FVC < 70%.

Exclusion Criteria:

  • respiratory exacerbation within the 2 months preceding the study, history of asthma, significant O2 desaturation (SaO2 < 85%) at rest or during exercise, presence of another pathology that could influence exercise tolerance.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01307189

Locations
Canada
Centre de recherche de l'IUCPQ
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Boehringer Ingelheim
Investigators
Principal Investigator: François Maltais, MD Laval University
  More Information

No publications provided

Responsible Party: Dr François Maltals, Laval University
ClinicalTrials.gov Identifier: NCT01307189     History of Changes
Other Study ID Numbers: CER1199
Study First Received: February 28, 2011
Last Updated: February 28, 2011
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
Chronic Obstructive Pulmonary Disease (COPD)
Exercise
Endurance shuttle walking test
Bronchodilation
Tiotropium

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014