Pulmonary Gas Exchange Abnormalities in Patients With Mild COPD

NCT ID: NCT02346604

Last Updated: 2015-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

Conditions

COPD

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Mild COPD

Symptomatic smokers with mild COPD

No interventions assigned to this group

Healthy Control

Non-smokers, matched to mild COPD group for age (at least 50 years) and gender

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ontario Lung Association

OTHER

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Denis O'Donnell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denis E O'Donnell, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen's University and Kingston General Hospital

Locations

Respiratory Investigation Unit at Kingston General Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

DMED-1458-12

Identifier Type: -

Identifier Source: org_study_id