NCT06825013RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 13 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 3 Feb 2025
- Start date
- 10 Nov 2024
- Primary completion date
- Jan 2027
- Lead sponsor
- Dr. J. Alberto Neder
- Diseases
- COPD
- NCT number
- NCT06825013
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 25
- From 10 Nov 2024 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Use of daytime oxygen or exercise induced O2 desaturation to \< 80% on room air;
- Any contraindication to cardiopulmonary exercise testing
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Respiratory Investigation Unit, Kingston Health Sciences Center Coordinator of this site? Confirm its status | Kingston | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.