Sponsor study identifier
observational
22
1 country
1
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 2015
Actual (reported)January 2015
Actual (reported)January 7, 2015
Actual (reported)January 27, 2015
Actual (reported)ventilatory equivalent for carbon dioxide (VE/VCO2)
Exercise will consist of a symptom-limited incremental test on a cycle ergometer
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.
dead space to tidal volume ratio (VD/VT)
Measured at standardized work rates during exercise
arterial blood gas measurements
Measured at standardized work rates during exercise
dyspnea intensity measured using the modified 10-point Borg scale
Measured at standardized work rates during exercise
Symptomatic smokers with mild COPD
Non-smokers, matched to mild COPD group for age (at least 50 years) and gender
Patients fitting GOLD grade 1B criteria for mild COPD
Respiratory Investigation Unit at Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Denis E O'Donnell, MD, FRCPC
Queen's University and Kingston General Hospital
22 participants (actual enrollment reported by the registry).
First Submitted
January 7, 2015
First Posted
January 27, 2015
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
November 20, 2015
Record last verified: 2015-11
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Source: ClinicalTrials.gov.
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