NCT06825013 Bronchodilators and Lung Mechanics During Exercise in COPD
| NCT ID | NCT06825013 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Dr. J. Alberto Neder |
| Condition | COPD |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-11-10 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 25 participants in total. It began in 2024-11-10 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
J Alberto Neder, MD, PhD
PRINCIPAL INVESTIGATOR
Queen's University
Frequently Asked Questions
Who can join the NCT06825013 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06825013 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06825013 currently recruiting?
Yes, NCT06825013 is actively recruiting participants. Contact the research team at nederalb@gmail.com for enrollment information.
Where is the NCT06825013 trial being conducted?
This trial is being conducted at Kingston, Canada.
Who is sponsoring the NCT06825013 clinical trial?
NCT06825013 is sponsored by Dr. J. Alberto Neder. The principal investigator is J Alberto Neder, MD, PhD at Queen's University. The trial plans to enroll 25 participants.
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