Actively Recruiting

Phase 4
Age: 40Years +
All Genders
ID06825013

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

Led by Dr. J. Alberto Neder · Updated on 2025-02-13

25

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of short-acting bronchodilators on lung function and breathlessness in people with chronic obstructive pulmonary disease (COPD). The study aims to determine whether these bronchodilators reduce resistance in the smallest airways of the lungs during exercise, and if this leads to improvements in breathlessness and exercise ability. Small airway disease is a major cause of airway obstruction in COPD, and better medication delivery to these airways could help ease symptoms such as shortness of breath during activity. Participants will receive either a combination of short-acting bronchodilators (salbutamol sulfate and ipratropium bromide) or a placebo (normal saline) via nebulizer in a randomized, crossover design. The study includes three visits over 2 to 3 weeks. The first visit assesses eligibility and lung function, including spirometry and exercise capacity tests. The second and third visits involve exercise tests with either the bronchodilator or placebo, with detailed lung measurements taken before and after treatment. During the exercise visits, participants will pedal on a stationary bike while lung function and breathing mechanics are closely monitored using specialized equipment. Measurements include airway resistance, lung volumes, diaphragm electrical activity, and respiratory pressures. Breathlessness and leg fatigue will be assessed using a scale, and vital signs will be monitored throughout. The main outcome is airway resistance measured at multiple time points during exercise. The total participation time spans about 2 to 3 weeks.

CONDITIONS

Brief Title

Bronchodilators and Lung Mechanics During Exercise in COPD

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of COPD
  • Male or female aged 40 years or older
  • Current or former smokers with at least 20 pack-year history
  • Forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC) below lower limit of normal
  • Pre-post change of forced vital capacity (FVC) of at least 10% predicted after inhaled salbutamol
  • Functional residual capacity at least 120% predicted and/or above the upper limit of normal
  • Modified Medical Research Council dyspnea scale score of 2 or higher
  • Clinically stable with no exacerbations in the past 6 weeks
  • Ability to provide informed consent and perform study procedures
Not Eligible

You will not qualify if you...

  • Major heart or lung diseases other than COPD such as asthma, interstitial lung disease, pulmonary hypertension, or congestive heart failure
  • Neuromuscular or musculoskeletal diseases
  • Use of daytime oxygen or exercise-induced oxygen saturation below 80% on room air
  • Any other condition that may cause breathlessness or limit exercise
  • Any contraindication to cardiopulmonary exercise testing

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 to 3 weeks

Participants receive either a short-acting bronchodilator or placebo via nebulizer in a randomized crossover design to assess their effects on lung function and exercise tolerance.

3 visits (in-person) approximately 2 to 7 days apart

Trial Site Locations

Total: 1 location

1

Respiratory Investigation Unit, Kingston Health Sciences Center

Kingston, Ontario, Canada, K7L 2V6

Actively Recruiting

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Research Team

J

J Alberto Neder Serafini, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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