Recruiting

Observational Study

Sponsor:

Laval University

Code:

NCT01655199

Conditions

Moderate Chronic Obstructive Pulmonary Disease

Severe Chronic Obstructive Pulmonary Disease

Dyspnea

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Combination ipratropium/salbutamol or placebo (nebulization)

Study Details

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.

Conditions

Moderate Chronic Obstructive Pulmonary Disease

Severe Chronic Obstructive Pulmonary Disease

Dyspnea

Study ID

NCT01655199

Start date

Sep, 2012

Status verified date

Sep, 2013

Completion date

Jul, 2014

Anticipated

Primary completion date

Jul, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: COPD group

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

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.

Primary outcome measure

  • Symptom perception [ Time Frame: change from baseline in Borg Scale at 3 min of exercise ]

Central Contacts and Locations

Locations

Montreal Chest Institute - McGill University

Recruiting

Montréal, Quebec, Canada

Contacts

Jean Bourbeau, M.D

jean.bourbeau@mcgill.ca

Hélène Perrault, Ph.D

helene.perrault@mcgill.ca

More Information

Sponsor

Laval University

Last update posted

Sep 18, 2013

Last verified

Sep, 2013

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2013-09-18.