Pulmonary Gas Exchange Abnormalities in Patients With Mild COPD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02346604|
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : November 20, 2015
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|Observational Model:||Case Control|
|Official Title:||Pulmonary Gas Exchange Abnormalities in Patients With Mild COPD|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Symptomatic smokers with mild COPD
Non-smokers, matched to mild COPD group for age (at least 50 years) and gender
- 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
- dead space to tidal volume ratio (VD/VT) [ Time Frame: Measured at standardized work rates during exercise ]
- 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.
- dyspnea intensity measured using the modified 10-point Borg scale [ Time Frame: Measured at standardized work rates during exercise ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346604
|Respiratory Investigation Unit at Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 2V7|
|Principal Investigator:||Denis E O'Donnell, MD, FRCPC||Queen's University and Kingston General Hospital|