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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Respiratory Investigation Unit, Kingston Health Sciences Center
RECRUITING
Kingston
Contact Information
Primary
J Alberto Neder Serafini, MD, PhD
nederalb@gmail.com
800-985-8891
Time Frame
Start Date: 2024-11-10
Estimated Completion Date: 2027-01
Participants
Target number of participants: 25
Treatments
Active_comparator: Bronchodilator
Participants will receive a combination short-acting bronchodilator (Salbutamol sulphate (2.5 mg) + ipratropium bromide (0.5 mg)) via nebulizer.
Placebo_comparator: Placebo
Participants will receive normal saline via nebulizer.
Sponsors
Leads: Dr. J. Alberto Neder

This content was sourced from clinicaltrials.gov