Recruiting

Bronchodilators

Sponsor:

Dr. J. Alberto Neder

Code:

NCT06825013

Conditions

COPD

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Bronchodilators inhalation

Placebo

Study Details

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.

Conditions

COPD

Study ID

NCT06825013

Start date

Nov 10, 2024

Status verified date

Feb, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Bronchodilators inhalation

Salbutamol sulphate (2.5 mg) + ipratropium bromide (0.5 mg)

Placebo

Nebulized saline

Primary outcome measure

  • Airway resistance [ Time Frame: At 2, 4, 6, 8, and 10 minutes from start of exercise ]

Central Contacts and Locations

Central contacts

J Alberto Neder Serafini, MD, PhD

800-985-8891nederalb@gmail.com

Locations

Respiratory Investigation Unit, Kingston Health Sciences Center

Recruiting

Kingston, Ontario, Canada, K7L 2V6

Contacts

J Alberto Neder Serafini, MD, Phd

800-549-6666nederalb@gmail.com

Principal Investigator:

J Alberto Neder Serafini, MD, PhD

More Information

Sponsor

Dr. J. Alberto Neder

Last update posted

Feb 13, 2025

Last verified

Feb, 2025

Keywords

  • Bronchodilators
  • Dyspnea
  • COPD
  • Exercise
  • Lung mechanics
  • Physiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. J. Alberto Neder on 2025-02-13.