Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease (CODEx)
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|ClinicalTrials.gov Identifier: NCT01655199|
Recruitment Status : Unknown
Verified September 2013 by Benoit Borel, Laval University.
Recruitment status was: Recruiting
First Posted : August 1, 2012
Last Update Posted : September 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Moderate Chronic Obstructive Pulmonary Disease Severe Chronic Obstructive Pulmonary Disease Dyspnea||Drug: Combination ipratropium/salbutamol or placebo (nebulization)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||July 2014|
Experimental: COPD group
Moderate and/or severe COPD patients, corresponding to GOLD stages II and III.
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)
- Symptom perception [ Time Frame: change from baseline in Borg Scale at 3 min of exercise ]Patients will be asked to score their dyspnea and leg discomfort perception using a 10-point Borg scale.
- Cardiac and ventilatory outcomes [ Time Frame: Change from baseline at 3 minutes of exercise ]Metabolic, cardiac and ventilatory parameters will be measured using a metabolic cart. Principal outcomes will be oxygen uptake (VO2), carbon dioxide output (VCO2), ventilation (VE), breathing frequency (BF), tidal volume (Vt) and heart rate (HR).
- Inspiratory capacity [ Time Frame: Change from baseline at the end of the exercise. ]Inspiratory capacity will be measured at rest and at the end of the 3-min step test (immediately following the assessment of dyspnea at 3 minutes).
- Respiratory pressures and diaphragm EMG [ Time Frame: Change from baseline at 1, 2 and 3 minutes of exercise ]Tidal excursion in pleural pressure will be measured using an oesophageal balloon-catheter system that will be positioned using standardized technique (n=40). Gastric and transdiaphragmatic pressures as well as the diaphragm electromyogram will be recorded in the 20 subjects studied at McGill University using a multipair esophageal electrode-balloon catheter.
- Pulmonary function [ Time Frame: At baseline and 60-min after the nebulization of either placebo and bronchodilator ]Pulmonary function will be measured by spirometry and plethysmography in the initial visit. In the subsequent visits, pulmonary function will be evaluated by spirometry before and 60-min after the nebulization of either placebo or bronchodilator.
- Maximal oxygen consumption [ Time Frame: Change from baseline at 1, 2 and 3 minutes of exercise ]Exercise capacity will be directly assessed following an incremental cycle exercise test. The exercise capacity was defined as the maximal oxygen consumption (VO2 peak, ml/kg/min) by direct measurements of gas exchanges.
- Maximal inspiratory pressure (PImax) [ Time Frame: Change from baseline after 3 minutes of exercise ]The maximum inspiratory pressure (PImax) will be measured during a sniff manoeuvre. These measurements will allow to construct the ratio of respiratory effort (tidal Pes/PImax) to thoracic displacement (VT/predicted VC), an index of neuromechanical coupling
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655199
|Contact: François Maltais, M.D||418-656-4747||Francois.Maltais@fmed.ulaval.ca|
|Contact: Benoit Borel, Ph.D||418-656-8711 ext email@example.com|
|Montreal Chest Institute - McGill University||Recruiting|
|Montréal, Quebec, Canada|
|Contact: Jean Bourbeau, M.D firstname.lastname@example.org|
|Contact: Hélène Perrault, Ph.D email@example.com|
|Sub-Investigator: Jean Bourbeau, M.D|
|Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval||Active, not recruiting|
|Québec, Quebec, Canada|
|Principal Investigator:||François Maltais, M.D||Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval|