Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease (CODEx)
Tracking Information | |||||||||
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First Received Date ICMJE | July 25, 2012 | ||||||||
Last Updated Date | July 31, 2012 | ||||||||
Start Date ICMJE | September 2012 | ||||||||
Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Symptom perception [ Time Frame: change from baseline in Borg Scale at 3 min of exercise ] [ Designated as safety issue: No ] Patients will be asked to score their dyspnea and leg discomfort perception using a 10-point Borg scale. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01655199 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease | ||||||||
Official Title ICMJE | Measurement of Exertional Dyspnea in the Primary Care Setting in Patients With COPD, Phase III: Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With COPD | ||||||||
Brief Summary | During the previous phases of the project (Phase I and II), two new field tests have been designed and validated for an integration in a primary care setting in Chronic Obstructive Pulmonary Disease (COPD). These new field tests are 3-min paced-walk test (3MPWT) and 3-min paced step test (3MPST). If the validity and sensitivity of the TM3 could be highlighted, particularly by the reduction of dyspnea level following bronchodilatation, Phase II highlight that the 3MPST does not allow to detect this decrease of dyspnea after bronchodilatation. The use of too high step rates could explain these results through a hypothesis relative to neuromechanical coupling of dyspnea. The main objective of this trial is to follow the investigations on the sensitivity of 3MPST to detect the effects of pharmacological intervention on the exertional dyspnea in COPD patient. The hypothesis of this work is that the use of lower step rates cadences could allow to detect an improvement of exertional dyspnea following treatment-induced bronchodilatation, contrary to higher step rates. |
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Detailed Description | For this project, 40 patients with COPD will be recruited in 2 centres (in the Institute of Cardiology and Pneumology of Quebec and in the Chest Institute of Montreal). For each patient, three visits will be performed. During the first visit, baseline pulmonary function and maximal exercise capacity will be evaluated and the patients will be familiarized with step test proceedings. Between the different visits, a 3-7 days period will be respected. During the second and the third visits, 4 step tests will be performed at 4 different rates, following one of the two conditions (placebo or bronchodilatation). This project will propose two randomization levels. The first randomization will be relative to the choice of the condition used during the second visit (placebo ou bronchodilatation) and the second one for the rates order (14, 16, 20, 24 steps/min). During each performed exercise, cardiorespiratory and pulmonary parameters will be measured using a portable system. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | |||||||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Drug: Combination ipratropium/salbutamol or placebo (nebulization)
For the visit 2, COPD patients will be randomly assigned a combination of ipratropium/salbutamol or a placebo in a double-blind crossover design. For the visit 3, the other intervention drug will be assigned. The bronchodilation obtained with the medication will allow to determine if the 3-min step test is sensitive by detecting an improvement of exertional dyspnea following bronchodilation.
Other Name: Combivent or placebo (nebulization) |
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Study Arm (s) | Experimental: COPD group
Moderate and/or severe COPD patients, corresponding to GOLD stages II and III.
Intervention: Drug: Combination ipratropium/salbutamol or placebo (nebulization) |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE | 40 | ||||||||
Estimated Completion Date | July 2013 | ||||||||
Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 50 Years to 80 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Canada | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01655199 | ||||||||
Other Study ID Numbers ICMJE | CODEX-20819 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Benoit Borel, Laval University | ||||||||
Study Sponsor ICMJE | Laval University | ||||||||
Collaborators ICMJE | Université de Montréal | ||||||||
Investigators ICMJE |
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Information Provided By | Laval University | ||||||||
Verification Date | July 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |