Inhaled Bronchodilators and Breathing During Exercise in COPD
Tests inhaled bronchodilators against placebo in adults with COPD during exercise.
Key facts
- Who runs it
- Dr. J. Alberto Neder
- Where
- Kingston, CanadaSee the site
- Trial code
- Registry title
- Bronchodilators and Lung Mechanics During Exercise in COPD
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 25 people, planned
- Started
- 10 Nov 2024
- Expected to end
- Jan 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Bronchodilators inhalation
- Placebo
- Record updated
- 13 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older with COPD who are current or former smokers and are clinically stable. It tests whether a short-acting bronchodilator helps breathing during exercise compared with placebo.
- Age
- 40 years or older
- Sex
- Men and women
- Disease stage
- COPD with a lower than normal FEV1/FVC ratio, breathlessness score (modified Medical Research Council scale) of 2 or more, and no flare-ups in the past 6 weeks.
- Biomarker or test result
- Smoking history of at least 20 pack-years (current or former smokers). Lung function tests: FVC rises by at least 10% predicted after 400 mcg inhaled salbutamol; functional residual capacity at least 120% predicted and/or above the upper limit of normal.
Main reasons for not taking part
- Major heart or lung disease other than COPD (asthma, interstitial lung disease, pulmonary hypertension, heart failure)
- Nerve, muscle or bone disease
- Daytime oxygen use, or oxygen level falling below 80% on room air during exercise
- Any other condition that may cause breathlessness or poor exercise tolerance
- Any reason that makes heart and lung exercise testing unsafe
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Use of daytime oxygen or exercise induced O2 desaturation to < 80% on room air
- Any contraindication to cardiopulmonary exercise testing
Where in Canada
- Respiratory Investigation Unit, Kingston Health Sciences CenterKingston, CanadaContact: J Alberto Neder Serafini, MD, PhdTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- BronchodilatorExisting treatment, for comparison
Participants will receive a combination short-acting bronchodilator (Salbutamol sulphate (2.5 mg) + ipratropium bromide (0.5 mg)) via nebulizer.
Treatment: Bronchodilators inhalation
- PlaceboPlacebo, for comparison
Participants will receive normal saline via nebulizer.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Bronchodilators and Dynamic Lung Mechanics During Exercise in COPD: Protocol for a Randomised, Placebo-controlled Crossover Trial
- Plain-language title
- Inhaled Bronchodilators and Breathing During Exercise in COPDGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 13 February 2025