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

NCT06825013 Phase 4 RECRUITING

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.

Details

Lead sponsor	Dr. J. Alberto Neder
Phase	Phase 4
Status	RECRUITING
Enrolment	25
Start date	2024-11-10
Completion	2027-01

Conditions

• COPD

Interventions

• Bronchodilators inhalation
• Placebo

Primary outcomes

• Airway resistance — At 2, 4, 6, 8, and 10 minutes from start of exercise
  Primary objective is to measure airway resistance measured by impulse oscillometry at isotime (maximum exercise time achieved by all participants) during cardiopulmonary exercise testing (cycle ergometer).

Countries

Canada