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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Laval University
Sponsor:
Collaborator:
Université de Montréal
Information provided by (Responsible Party):
Benoit Borel, Laval University
ClinicalTrials.gov Identifier:
NCT01655199
First received: July 25, 2012
Last updated: September 17, 2013
Last verified: September 2013
  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 Blind (Subject, 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:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Cardiac and ventilatory outcomes [ Time Frame: Change from baseline at 3 minutes of exercise ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Benoit Borel, Postdoctoral fellow, Laval University
ClinicalTrials.gov Identifier: NCT01655199     History of Changes
Other Study ID Numbers: CODEX-20819
Study First Received: July 25, 2012
Last Updated: September 17, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Laval University:
Chronic Obstructive Pulmonary Disease
Lung function
Exertional dyspnea
Exercise capacity
Pulmonary function
Pleural pressures

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Dyspnea
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Ipratropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014