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

NCT01655199 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-09-18

No results posted yet for this study

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.

Conditions

  • Moderate Chronic Obstructive Pulmonary Disease
  • Severe Chronic Obstructive Pulmonary Disease
  • Dyspnea

Interventions

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.

Sponsors & Collaborators

  • Université de Montréal

    collaborator OTHER

  • Laval University

    lead OTHER

Principal Investigators

  • François Maltais, M.D · Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01655199 on ClinicalTrials.gov