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

Laval University

Status: Unknown

Conditions: Dyspnea; Moderate Chronic Obstructive Pulmonary Disease; Severe Chronic Obstructive Pulmonary Disease

Treatments: Drug: Combination ipratropium/salbutamol or placebo (nebulization)

Study type: Interventional

Funder types: Other

Identifiers

NCT01655199

CODEX-20819

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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40 participants in 1 patient group

COPD group

Experimental group

Description:

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

Treatment:

Drug: Combination ipratropium/salbutamol or placebo (nebulization)