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NCT Number: NCT00975403

Pathophysiological Mechanisms of Dyspnea and Activity-limitation in Mild Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a growing cause of death, disability and health care costs in Canada. Nevertheless, COPD remains largely under-diagnosed and under-treated, particularly in its early stages. Patients with mild COPD have variable respiratory symptoms and often go unrecognized by their caregivers. Recent studies indicate that even smokers with near normal breathing test results can have extensive small airway disease/dysfunction at rest, which becomes more pronounced during the stress of exercise thus leading to unpleasant breathing difficulty. This study seeks to better understand the nature and causes of breathing discomfort and activity limitation in a group of patients with mild COPD. The investigators will compare detailed tests of small airway function and conduct an evaluation of several key physiological parameters during the stress of exercise in patients with mild COPD and in healthy, age-matched, non-smoking control subjects. The investigators will also compare detailed physiological responses to exercise under conditions of chemical loading and mechanical unloading of the respiratory system in patients with mild COPD.

The proposed study will be the first to systematically test the hypothesis that pathophysiological abnormalities in ventilatory demand, pulmonary gas exchange, small airway function, dynamic ventilatory mechanics and respiratory muscle function contribute significantly to exertional dyspnea and activity-limitation in patients with mild COPD. This study will be the first to determine if these abnormalities can be manipulated.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respiratory Investigation Unit, Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Post-bronchodilator forced expiratory volume in 1 sec (FEV1) ≥ 80%predicted and a FEV1/forced vital capacity (FVC) ratio < 0.70;
  • Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospitalizations in the preceding 6 weeks;
  • A cigarette smoking history ≥ 20 pack-yrs;
  • Body mass index between 18.5 and 30 kg/m2;
  • Able to perform all study procedures and provide informed consent.

Exclusion criteria

  • A diffusing capacity of the lung for carbon monoxide (DLCO) < 40 %predicted;
  • Presence of active cardiopulmonary disease (or comorbidities) other than COPD that could contribute to dyspnea and exercise limitation;
  • Clinical diagnosis of sleep disordered breathing;
  • History or clinical evidence of asthma;
  • Presence of important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s);
  • Use of daytime oxygen or exercise-induced arterial oxygen desaturation to <80% on room air.

Treatment and study plan

Dead space breathing

Device

Chemical loading by adding a deadspace (600ml) to the breathing circuit during a single cycle exercise test

Room air breathing

Device

Sham comparator (vs deadspace) during a single cycle exercise test will entail breathing room air on the same circuit without the rebreathe valves

Primary outcomes

  1. Dyspnea intensity measured by the 10-point Borg scale during cycle exercise

    Time frame: Standardized time during exercise

Secondary outcomes

  1. Cycle exercise endurance time

    Time frame: During exercise testing at study visits

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Canadian Lung Association

Registry information

Official study title

Pathophysiological Mechanisms of Dyspnea and Activity-Limitation in Mild COPD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 11, 2009
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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