Bronchodilators and Lung Mechanics During Exercise in COPD

NCT06825013 | Recruiting Phase 4

• 1 other identifier: SOUND STUDY
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Bronchodilators; Dyspnea; COPD; Exercise; Lung mechanics; Physiology

Outcome Measures

Primary Outcomes (1)

• Airway resistance

  Primary objective is to measure airway resistance measured by impulse oscillometry at isotime (maximum exercise time achieved by all participants) during cardiopulmonary exercise testing (cycle ergometer).

  At 2, 4, 6, 8, and 10 minutes from start of exercise

Secondary Outcomes (7)

• Inspiratory neural drive

  At 2, 4, 6, 8, and 10 minutes from start of exercise

• Esophageal Pressure (Pes)

  At 2, 4, 6, 8, and 10 minutes from start of exercise

• Gastric Pressure (Pga)

  At 2, 4, 6, 8, and 10 minutes from start of exercise

• Trans-diaphragmatic Pressure (Pdi)

  At 2, 4, 6, 8, and 10 minutes from start of exercise

• Operating lung volumes

  At 2, 4, 6, 8, and 10 minutes from start of exercise

Study Arms (2)

Bronchodilator

ACTIVE COMPARATOR

Participants will receive a combination short-acting bronchodilator (Salbutamol sulphate (2.5 mg) + ipratropium bromide (0.5 mg)) via nebulizer.

Drug: Bronchodilators inhalation

Placebo

PLACEBO COMPARATOR

Participants will receive normal saline via nebulizer.

Drug: Placebo

Interventions

Bronchodilators inhalation DRUG

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

Bronchodilator

Placebo DRUG

Nebulized saline

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. J. Alberto Neder: lead

Study Sites (1)

Respiratory Investigation Unit, Kingston Health Sciences Center

Kingston, Ontario, K7L 2V6, Canada

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Behavior

Study Officials

• J Alberto Neder, MD, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J Alberto Neder Serafini, MD, PhD

CONTACT

800-985-8891; nederalb@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Alberto Neder, Professor, Dept. of Respirology, Queen's University

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 13, 2025
• Study Start: November 10, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will not be released until study completion (anticipated January 2027).
• Access Criteria: Data will be released on reasonable request after appropriate ethical approval, anonymization, and data sharing agreements to ensure data integrity and participant privacy.

Locations

CA (1)