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Pulmonary Gas Exchange Abnormalities in Patients With Mild COPD

Q

Queen's University

Status

Completed

Conditions

COPD

Study type

Observational

Funder types

Other

Identifiers

NCT02346604
DMED-1458-12

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

22 participants in 2 patient groups

Mild COPD
Description:
Symptomatic smokers with mild COPD
Healthy Control
Description:
Non-smokers, matched to mild COPD group for age (at least 50 years) and gender

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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