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Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease (CODEx)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified September 2013 by Benoit Borel, Laval University.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01655199

First Posted: August 1, 2012

Last Update Posted: September 18, 2013

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.

Collaborator:

Université de Montréal

Information provided by (Responsible Party):

Benoit Borel, Laval University

Purpose

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.

Condition	Intervention
Moderate Chronic Obstructive Pulmonary Disease Severe Chronic Obstructive Pulmonary Disease Dyspnea	Drug: Combination ipratropium/salbutamol or placebo (nebulization)


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Diagnostic
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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Breathing Problems COPD Lung Diseases

Drug Information available for: Albuterol Ipratropium bromide Levalbuterol hydrochloride Albuterol sulfate

U.S. FDA Resources

Further study details as provided by Benoit Borel, Laval University:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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


Estimated Enrollment:	40
Study Start Date:	September 2012
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Arms

Assigned Interventions

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)

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age higher than 50 years old
smoking history ≥ 10 packs/year
post-bronchodilator FEV1 between 30 and 80% of the predicted value and FEV1/FVC lesser than 70% as assessed in previous pulmonary function test (corresponding to GOLD stages II and III)

Exclusion Criteria:

respiratory exacerbation within the preceding 6 weeks
asthmatic condition
significant O2 desaturation (SaO2 < 85%) at rest or during exercise
presence of another pathology that could influence exercise tolerance or may prevent the realization of the step test
subject having a pacemaker

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01655199

Contacts


Contact: François Maltais, M.D	418-656-4747	Francois.Maltais@fmed.ulaval.ca
Contact: Benoit Borel, Ph.D	418-656-8711 ext 3995	benoit.borel@criucpq.ulaval.ca

Locations


Canada, Quebec
Montreal Chest Institute - McGill University	Recruiting
Montréal, Quebec, Canada
Contact: Jean Bourbeau, M.D jean.bourbeau@mcgill.ca
Contact: Hélène Perrault, Ph.D helene.perrault@mcgill.ca
Sub-Investigator: Jean Bourbeau, M.D
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval	Active, not recruiting
Québec, Quebec, Canada

Sponsors and Collaborators

Laval University

Université de Montréal

Investigators


Principal Investigator:	François Maltais, M.D	Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

More Information


Responsible Party:	Benoit Borel, Postdoctoral fellow, Laval University
ClinicalTrials.gov Identifier:	NCT01655199 History of Changes
Other Study ID Numbers:	CODEX-20819
First Submitted:	July 25, 2012
First Posted:	August 1, 2012
Last Update Posted:	September 18, 2013
Last Verified:	September 2013

Keywords provided by Benoit Borel, Laval University:


Chronic Obstructive Pulmonary Disease Lung function Exertional dyspnea	Exercise capacity Pulmonary function Pleural pressures

Additional relevant MeSH terms:


Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Dyspnea Respiratory Tract Diseases Respiration Disorders Signs and Symptoms, Respiratory Signs and Symptoms Albuterol Ipratropium Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Cholinergic Agents

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