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

NCT01655199 | Unknown DMC

• 1 other identifier: CODEX-20819
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Symptom perception

  Patients will be asked to score their dyspnea and leg discomfort perception using a 10-point Borg scale.

  change from baseline in Borg Scale at 3 min of exercise

Secondary Outcomes (6)

• Cardiac and ventilatory outcomes

  Change from baseline at 3 minutes of exercise

• Inspiratory capacity

  Change from baseline at the end of the exercise.

• Respiratory pressures and diaphragm EMG

  Change from baseline at 1, 2 and 3 minutes of exercise

• Pulmonary function

  At baseline and 60-min after the nebulization of either placebo and bronchodilator

• Maximal oxygen consumption

  Change from baseline at 1, 2 and 3 minutes of exercise

Study Arms (1)

COPD group

EXPERIMENTAL

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

Drug: Combination ipratropium/salbutamol or placebo (nebulization)

Interventions

Combination ipratropium/salbutamol or placebo (nebulization) 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.

Also known as: Combivent or placebo (nebulization)

COPD group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Université de Montréal: collaborator

Study Sites (2)

Montreal Chest Institute - McGill University

Montreal, Quebec, Canada

RECRUITING

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

Québec, Quebec, Canada

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Albuterol; Albuterol, Ipratropium Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Ipratropium; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• François Maltais, M.D

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François Maltais, M.D

CONTACT

418-656-4747; Francois.Maltais@fmed.ulaval.ca

Benoit Borel, Ph.D

CONTACT

418-656-8711; benoit.borel@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral fellow

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: August 1, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 18, 2013

Record last verified: 2013-09

Locations

CA (2)