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

Moderate Chronic Obstructive Pulmonary Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Moderate Chronic Obstructive Pulmonary Disease

Severe Chronic Obstructive Pulmonary Disease

Dyspnea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Study Status

Unknown status

Start Date: September 2012

Completed Date: July 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Symptom perception

Secondary Outcome: Cardiac and ventilatory outcomes

Study sponsors, principal investigator, and references

Principal Investigator: François Maltais, M.D

Lead Sponsor: Laval University

Collaborator: Université de Montréal

More information:https://clinicaltrials.gov/show/NCT01655199

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