Effects of bronchodilators on breathing during exercise in COPD patients
Bronchodilators and Dynamic Lung Mechanics During Exercise in COPD: Protocol for a Randomised, Placebo-controlled Crossover Trial
This study tests if a new breathing medication can help people with COPD breathe easier and feel less short of breath while exercising.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Queen's University Academic / other |
| Locations | 1 site (Kingston, Ontario) |
| Trial ID | NCT06825013 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of short-acting bronchodilators on small airway resistance and breathlessness in patients with chronic obstructive pulmonary disease (COPD) during exercise. Participants will receive either the bronchodilator or a placebo in a controlled setting, with assessments made on their lung mechanics and exercise endurance. The study aims to clarify whether improved medication delivery to small airways can enhance breathing and reduce feelings of dyspnea during physical activity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with a diagnosis of COPD and a significant smoking history.
Not a fit: Patients with major cardiopulmonary diseases other than COPD or those with neuromuscular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of breathlessness and improved exercise capacity for COPD patients.
How similar studies have performed: Other studies have shown promising results with bronchodilator therapies in COPD, but this specific approach focusing on small airways is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Kingston, Ontario
- Respiratory Investigation Unit, Kingston Health Sciences Center — Kingston, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: J Alberto Neder, MD, PhD — Queen's University
- Study coordinator: J Alberto Neder Serafini, MD, PhD
- Email: nederalb@gmail.com
- Phone: 800-985-8891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.