RecruitingPhase 4NCT06825013

Bronchodilators and Lung Mechanics During Exercise in COPD

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


Sponsor

Dr. J. Alberto Neder

Enrollment

25 participants

Start Date

Nov 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 Years

Inclusion Criteria9

  • 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 Criteria5

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

Interventions

DRUGBronchodilators inhalation

Salbutamol sulphate (2.5 mg) + ipratropium bromide (0.5 mg)

DRUGPlacebo

Nebulized saline


Locations(1)

Respiratory Investigation Unit, Kingston Health Sciences Center

Kingston, Ontario, Canada

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NCT06825013


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