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

NCT ID: NCT01655199

Last Updated: 2013-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-07-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

COPD group

Moderate and/or severe COPD patients, corresponding to GOLD stages II and III.

Group Type: EXPERIMENTAL

Combination ipratropium/salbutamol or placebo (nebulization)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Combivent or placebo (nebulization)

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Montréal

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Benoit Borel

Postdoctoral fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

François Maltais, M.D

Role: PRINCIPAL_INVESTIGATOR

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Locations

Montreal Chest Institute - McGill University

Montreal, Quebec, Canada

Site Status: RECRUITING

Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval

Québec, Quebec, Canada

Site Status: ACTIVE_NOT_RECRUITING

Countries

Canada

Central Contacts

François Maltais, M.D

Role: CONTACT

Phone: 418-656-4747

Email: Francois.Maltais@fmed.ulaval.ca

Benoit Borel, Ph.D

Role: CONTACT

Phone: 418-656-8711

Email: benoit.borel@criucpq.ulaval.ca

Facility Contacts

Jean Bourbeau, M.D

Role: primary

Hélène Perrault, Ph.D

Role: backup

Other Identifiers

CODEX-20819

Identifier Type: -

Identifier Source: org_study_id