Sensitivity of New Exercise Tests in Chronic Obstructive Pulmonary Disease (COPD)
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
1 other identifier
interventional
44
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease
Started Oct 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 10, 2008
CompletedFirst Posted
Study publicly available on registry
December 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFebruary 9, 2011
May 1, 2010
1.2 years
December 10, 2008
February 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dyspnea at the end of the 3-minute walking and stepping exercises
at the end of the 3-minute exercises
Study Arms (2)
ipratropium bromide
ACTIVE COMPARATORacute bronchodilation: ipratropium bromide
placebo
PLACEBO COMPARATORplacebo nebulization
Interventions
nebulization of 500ug
nebulization of 500ug
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
- McGill Universitycollaborator
- Boehringer Ingelheimcollaborator
Study Sites (2)
Hélène Perrault
Montreal, Quebec, Canada
François Maltais
Québec, Quebec, G1V4G5, Canada
Related Publications (1)
Sava F, Perrault H, Brouillard C, Darauay C, Hamilton A, Bourbeau J, Maltais F. Detecting improvements in dyspnea in COPD using a three-minute constant rate shuttle walking protocol. COPD. 2012 Aug;9(4):395-400. doi: 10.3109/15412555.2012.674164. Epub 2012 Apr 18.
PMID: 22509905DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François Maltais, MD
Laval University
- PRINCIPAL INVESTIGATOR
Hélène Perrault, Ph.D.
McGill University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 10, 2008
First Posted
December 12, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2009
Study Completion
June 1, 2010
Last Updated
February 9, 2011
Record last verified: 2010-05