Pulmonary Gas Exchange Abnormalities in Patients With Mild COPD

COPD Clinical Trial

Official title:

Pulmonary Gas Exchange Abnormalities in Patients With Mild COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346604
• Other study ID #: DMED-1458-12
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: November 19, 2015
• Start date: July 2013
• Est. completion date: January 2015

Study information

• Verified date: November 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
Canada	Respiratory Investigation Unit at Kingston General Hospital	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Ontario Lung Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	dead space to tidal volume ratio (VD/VT)		Measured at standardized work rates during exercise	No
Secondary	arterial blood gas measurements	Measurements will include arterial oxygen tension (PaO2), arterial carbon dioxide tension (PaCO2), pH, hydrogen ion (H+), plasma bicarbonate (HCO3-) and lactate.	Measured at standardized work rates during exercise	No
Secondary	dyspnea intensity measured using the modified 10-point Borg scale		Measured at standardized work rates during exercise	No