Pulmonary Gas Exchange Abnormalities in Patients With Mild COPD

NCT02346604 | Completed

• 1 other identifier: DMED-1458-12
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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

Study Arms (2)

Mild COPD

Symptomatic smokers with mild COPD

Healthy Control

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients fitting GOLD grade 1B criteria for mild COPD

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead
• Ontario Lung Association: collaborator

Study Sites (1)

Respiratory Investigation Unit at Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Denis E O'Donnell, MD, FRCPC

  Queen's University and Kingston General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 27, 2015
• Study Start: July 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

CA (1)