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Pulmonary Gas Exchange Abnormalities in Patients With Mild COPD

Pulmonary Gas Exchange Abnormalities in Patients With Mild COPD

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02346604
Enrollment
22
Registered
2015-01-27
Start date
2013-07-31
Completion date
2015-01-31
Last updated
2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

exercise

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.

Interventions

None listed

Sponsors

Ontario Lung Association
CollaboratorOTHER
Queen's University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
ventilatory equivalent for carbon dioxide (VE/VCO2)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

MeasureTime frameDescription
dead space to tidal volume ratio (VD/VT)Measured at standardized work rates during exercise
arterial blood gas measurementsMeasured at standardized work rates during exerciseMeasurements 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 scaleMeasured at standardized work rates during exercise

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026