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Trial record 34 of 150 for:    Ipratropium OR atrovent

Sensitivity of New Exercise Tests in Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00807534
Recruitment Status : Completed
First Posted : December 12, 2008
Last Update Posted : February 9, 2011
McGill University
Boehringer Ingelheim
Information provided by:
Laval University

Brief Summary:

This study was designed to test the following hypothesis:

The 3-min constant rate step test and the 3-min constant rate shuttle walk test will be sensitive to detect improvement in exertional dyspnea following acute bronchodilation in patients with COPD.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: ipratropium bromide Drug: placebo Behavioral: constant rate step test Behavioral: constant rate shuttle walk test Not Applicable

Detailed Description:

BACKGROUND: Cycle and/or treadmill exercise modalities may not adequately reflect the constraints of the physical activities of daily living and may not easily transfer to the primary care setting. Thus, alternatives need to be considered. The use of a continuous shuttle walk test at one or several specified constant walking paces for the assessment of exertional dyspnea has not yet been developed. Since walking is the basic movement for locomotion in everyday life, it seems appropriate to examine the use of a walking test. In addition to walking, one of the most frequent exercise constraints of everyday life lies in the fact of climbing stairs. The step testing methodology has however not specifically focused on the measurement of exertional dyspnea and has not been carried out in patients with COPD. There is a good rationale for the development of a step test for evaluation of exertional dyspnea and exercise tolerance in the primary care setting: (i) simple, inexpensive equipment that requires very little storage space, (ii) ability to externally dictate the work intensity by use of a timing device such as a metronome to regulate the stepping speed, (iii) exercise that is consistent with everyday activity known to be an important dyspnea stimulus (i.e. stair climbing, hill walking), (iv) use of large muscle groups which ensures that ventilation is increased to support the working muscles, with a resultant increase in dyspnea in patients with reduced ventilatory capacity.

GENERAL OBJECTIVE: The general purpose of this investigator-driven initiative is to develop simple exercise tests to assess the effects of pharmacological and rehabilitation interventions on exertional dyspnea in the primary care setting.

METHODS: The study will require five visits at the research centre. The first visit will include pulmonary function testing and an incremental shuttle walking test to characterize the functional capacity of the participants. Patients will also be familiarized to both exercise tests (stepping and walking). 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. During the following four visits, patients will complete a total of four exercise tests: two 3-min constant rate step tests and two 3-min constant rate shuttle walks. Each test will be preceded by the nebulization of either a placebo or 500 ug of ipratropium bromide (Atrovent). The placebo or medication will be administered 1 hour prior to the beginning of each test. The study will follow a crossover design, such that each patient will serve as his/her own control. The order of the endurance tests (stepping or walking) will be randomized. Finally, the medication (placebo or ipratropium) will be administered in a randomized, double-blind fashion. The exercise test will be supervised by someone who is unaware of the medication that was administered in order to maintain blinding of the study.

Data analysis: Responsiveness will be evaluated by the change in dyspnea Borg score at completion of the 3-min constant rate stepping test and the 3-min constant rate walking test between the placebo and ipratropium bromide exercises. Paired t tests will be used to evaluate the difference in end-exercise dyspnea between the ipratropium and the placebo conditions for the two forms of exercise. We will also calculate the Standardized Response Mean (SRM), e.g., the mean change in dyspnea Borg score divided by standard deviation (SD) of mean change. A SRM value of 0.5 or more suggests a large change. Bronchodilator-induced changes in E, O2, CO2, and heart rate will be compared between the 3-min constant rate stepping test and the 3-min constant rate walking test. Comparisons will be done using a repeated measure design (ANOVA). Significance level will be set at a p value of 0.05.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Measurement of Exertional Dyspnea in the Primary Care Setting in Patients With COPD, Phase 2: Sensitivity of the Step Test and Shuttle Walk to Detect Improvement in Dyspnea Following Bronchodilation in Patients With COPD
Study Start Date : October 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: ipratropium bromide
acute bronchodilation: ipratropium bromide
Drug: ipratropium bromide
ipratropium bromide nebulization
Other Name: Atrovent

Behavioral: constant rate step test
nebulization of 500ug
Other Name: Atrovent

Behavioral: constant rate shuttle walk test
nebulization of 500ug
Other Name: Atrovent

Placebo Comparator: placebo
placebo nebulization
Drug: placebo
placebo nebulization

Behavioral: constant rate step test
nebulization of 500ug
Other Name: Atrovent

Behavioral: constant rate shuttle walk test
nebulization of 500ug
Other Name: Atrovent

Primary Outcome Measures :
  1. Dyspnea at the end of the 3-minute walking and stepping exercises [ Time Frame: at the end of the 3-minute exercises ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age > 50 years
  • smoking history > 10 packs/year
  • post-bronchodilator FEV1 between 30 and 80% predicted and FEV1/FVC < 70% as assessed in previous pulmonary function test (GOLD stage II and III)

Exclusion Criteria:

  • respiratory exacerbation within the preceding 2 months
  • history of asthma
  • significant O2 desaturation (SaO2 < 85%) at rest or during exercise
  • presence of another pathology that could influence exercise tolerance

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 identifier (NCT number): NCT00807534

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Canada, Quebec
Hélène Perrault
Montreal, Quebec, Canada
François Maltais
Quebec City, Quebec, Canada, G1V4G5
Sponsors and Collaborators
Laval University
McGill University
Boehringer Ingelheim
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Principal Investigator: François Maltais, MD Laval University
Principal Investigator: Hélène Perrault, Ph.D. McGill University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: François Maltais, Laval University Identifier: NCT00807534     History of Changes
Other Study ID Numbers: BI 244.2513
First Posted: December 12, 2008    Key Record Dates
Last Update Posted: February 9, 2011
Last Verified: May 2010
Keywords provided by Laval University:
Chronic Obstructive Pulmonary Disease (COPD)
3-min constant rate stepping test
3-min constant rate walking test
Ipratropium bromide
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action