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
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 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 firstname.lastname@example.org|
|Montreal Chest Institute - McGill University||Recruiting|
|Montréal, Quebec, Canada|
|Contact: Jean Bourbeau, M.D email@example.com|
|Contact: Hélène Perrault, Ph.D firstname.lastname@example.org|
|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|