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OpenTrials
Completed

NCT Number: NCT02346604

Pulmonary Gas Exchange Abnormalities in Patients With Mild COPD

People with mild chronic obstructive pulmonary disease (COPD) can have significant physiological abnormalities and breathing inefficiency which become more pronounced during the stress of exercise, leading to intolerable breathing discomfort (dyspnea). To better understand the mechanisms of respiratory symptoms and exercise limitation in mild COPD, we will examine detailed lung function tests and other important measurements during rest and exercise in people with mild COPD compared with healthy non-smokers. This will be the first study to uncover the fundamental causes of breathing inefficiency and the related shortness of breath during physical exertion in patients with mild COPD. We hope to demonstrate that one simple measurement during exercise [the relation (ratio) between the total amount of air breathed (ventilation) and the amount of carbon dioxide breathed out] gives meaningful information about the extent of damage to the small airways and blood vessels in mild COPD and the overall gas exchanging function of the lungs, without the need for an arterial blood sample.

This is a case-controlled observational study not involving an intervention. Participants will complete 2 visits approximately 1 week apart, each conducted at the same time of day. Visit 1 will consiste of screening for iligibility, symptom and activity assessments, pulmonary function tests and an incremental cycle cardiopulmonary exercise test (CPET) for familiarization purposes. Visit 2 will include spirometry followed by an incremental cycle CPET with detailed measures of ventilatory, gas exchange, sensory-perceptual and arterial blood gas responses.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Respiratory Investigation Unit at 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

  • Stable symptomatic patients with GOLD grade 1B mild COPD;
  • at least 50 years of age;
  • a cigarette smoking history ≥20 pack-years;
  • a Baseline Dyspnea Index focal score ≤9;
  • post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥80 %predicted and an FEV1/forced vital capacity (FVC) ratio <0.7 and < lower limit of normal.

Exclusion criteria

  • clinically significant comorbidities;
  • contraindications to exercise testing;
  • history/clinical evidence of asthma;
  • body mass index <18.5 or >30 kg/m2;
  • use of supplemental oxygen.

Treatment and study plan

Primary outcomes

  1. ventilatory equivalent for carbon dioxide (VE/VCO2)

    Time frame: Measured at its nadir during an exercise test. Participants will be followed for the amount of time taken to complete 2 study visits, an expected average duration between 1 and 2 weeks.

    Exercise will consist of a symptom-limited incremental test on a cycle ergometer

Secondary outcomes

  1. dead space to tidal volume ratio (VD/VT)

    Time frame: Measured at standardized work rates during exercise

  2. arterial blood gas measurements

    Time frame: Measured at standardized work rates during exercise

    Measurements will include arterial oxygen tension (PaO2), arterial carbon dioxide tension (PaCO2), pH, hydrogen ion (H+), plasma bicarbonate (HCO3-) and lactate.

  3. dyspnea intensity measured using the modified 10-point Borg scale

    Time frame: Measured at standardized work rates during exercise

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Ontario Lung Association

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 27, 2015
Registry last updated
Nov 20, 2015

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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