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Taking people in CanadaPhase 4

Inhaled Bronchodilators and Breathing During Exercise in COPD

Tests inhaled bronchodilators against placebo in adults with COPD during exercise.

Plain-language title generated from the registry record
Registry title: Bronchodilators and Lung Mechanics During Exercise in COPD

Key facts

Where
Kingston, CanadaSee the site
Phase
Phase 4

Where in Canada

  • Respiratory Investigation Unit, Kingston Health Sciences CenterKingston, CanadaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Dr. J. Alberto Neder
Trial code
NCT06825013
Record updated
13 February 2025
Original description
Bronchodilators are medications that open the bronchi to help patients with COPD to breathe better. It is still not known exactly how this effect improves shortness of breath in people with COPD. The goal of this clinical trial is to determine whether bronchodilators lower resistance in the smallest airways in the lungs, and whether this will improve the feeling of breathlessness in these patients.Read full original descriptionShow less

Bronchodilators and Dynamic Lung Mechanics During Exercise in COPD: Protocol for a Randomised, Placebo-controlled Crossover Trial

Bronchodilators are medications that open the bronchi to help patients with COPD to breathe better. It is still not known exactly how this effect improves shortness of breath in people with COPD. The goal of this clinical trial is to determine whether bronchodilators lower resistance in the smallest airways in the lungs, and whether this will improve the feeling of breathlessness in these patients.

The main questions the investigators attempt to answer are:

* In patients with COPD, does treatment with a short-acting bronchodilator improve small airway resistance during exercise? * In patients with COPD, does acute treatment with short-acting bronchodilator improve breathlessness and exercise endurance?

The investigators will compare short-acting bronchodilators to placebo (a substance that contains no drug) to see if the bronchodilator medications improve small airway resistance and breathlessness during exercise.

Participants will:

* Visit the research laboratory 3 visits to complete tests of lung function and exercise * Complete 2 identical visits (Visit 2 and 3), one in which the participant receives bronchodilator and one in which the participant receives placebo.

Inclusion: Diagnosis of COPD; Male or female ≥40-years-of-age; Current or former smokers with ≥20 pack-year history; Forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC)<lower limit of normal; Pre-Post Change of FVC ≥ 10% predicted after 400 mcg inhaled salbutamol; Functional residual capacity ≥120%predicted and/or the upper limit of normal; Modified Medical Research Council dyspnea scale ≥ 2; Clinically stable as defined by no exacerbations in the preceding 6 weeks; Ability to provide informed consent and perform all study procedures.

Exclusion: Major cardiopulmonary diseases other than COPD (asthma, interstitial lung disease, pulmonary hypertension, and congestive heart failure); Neuromuscular or musculoskeletal disease; Any other disorder that may contribute to exertional dyspnoea and/or exercise intolerance; Use of daytime oxygen or exercise induced O2 desaturation to < 80% on room air; Any contraindication to cardiopulmonary exercise testing.

ClinicalTrials.gov NCT06825013