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Trial record 59 of 667 for:    CARBON DIOXIDE AND arterial

Pulmonary Gas Exchange Abnormalities in Patients With Mild COPD

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ClinicalTrials.gov Identifier: NCT02346604
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
Ontario Lung Association
Information provided by (Responsible Party):
Dr. Denis O'Donnell, Queen's University

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.


Condition or disease
COPD

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Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case Control
Time Perspective: Prospective
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

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. dead space to tidal volume ratio (VD/VT) [ Time Frame: Measured at standardized work rates during exercise ]
  2. 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.

  3. dyspnea intensity measured using the modified 10-point Borg scale [ Time Frame: Measured at standardized work rates during exercise ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients fitting GOLD grade 1B criteria for mild COPD
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.

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Respiratory Investigation Unit at Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
Ontario Lung Association
Investigators
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Principal Investigator: Denis E O'Donnell, MD, FRCPC Queen's University and Kingston General Hospital

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Responsible Party: Dr. Denis O'Donnell, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT02346604     History of Changes
Other Study ID Numbers: DMED-1458-12
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Dr. Denis O'Donnell, Queen's University:
exercise
Additional relevant MeSH terms:
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Congenital Abnormalities