Clinical trial NCT01655199: Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Moderate Chronic Obstructive Pulmonary Disease
Severe Chronic Obstructive Pulmonary Disease
Dyspnea
Keywords: Chronic Obstructive Pulmonary Disease
Lung function
Exertional dyspnea
Exercise capacity
Pulmonary function
Pleural pressures
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Université de Montréal
First posted: 2012-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Symptom perception
timeFrame: change from baseline in Borg Scale at 3 min of exercise
Secondary outcomes:
measure: Cardiac and ventilatory outcomes
timeFrame: Change from baseline at 3 minutes of exercise
measure: Inspiratory capacity
timeFrame: Change from baseline at the end of the exercise.
measure: Respiratory pressures and diaphragm EMG
timeFrame: Change from baseline at 1, 2 and 3 minutes of exercise
measure: Pulmonary function
timeFrame: At baseline and 60-min after the nebulization of either placebo and bronchodilator
measure: Maximal oxygen consumption
timeFrame: Change from baseline at 1, 2 and 3 minutes of exercise
measure: Maximal inspiratory pressure (PImax)
timeFrame: Change from baseline after 3 minutes of exercise
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal Chest Institute - McGill University
state: Quebec
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
state: Quebec
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: François Maltais, M.D
role: PRINCIPAL_INVESTIGATOR
References: