NCT02235025

Asymptomatic Versus Symptomatic Mild COPD: Comparisons at Rest and at Exercise

Ventilatory Constraints During Exercise in Asymptomatic Versus Symptomatic Patients With Mild COPD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The current definition of chronic obstructive pulmonary disease (COPD) is based on the presence of persistent airflow obstruction assessed by spirometry. About half of the subjects with mild COPD (i.e. reduced forced expiratory volume in one second (FEV1) on forced vital capacity (FVC) ratio along with normal FEV1\] are asymptomatic. Subjects with symptomatic mild COPD have reduced exercise tolerance and abnormal dynamic ventilatory mechanics compared to healthy subjects. The physiological and perceptual responses to exercise of subjects with asymptomatic mild COPD are currently unknown. The purpose of this study is to assess exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea in asymptomatic mild COPD subjects undergoing incremental cycle cardiopulmonary exercise testing (CPET) to the limit of tolerance compared with symptomatic mild COPD and healthy controls.

Detailed description

Subjects attend one single visit. If needed, COPD subjects are asked to stop any respiratory related medication such as short and long acting bronchodilators 72 hours prior to the visit. Subjects are asked to arrive early in the morning. After informed consent and appropriate screening of medical history, all subjects complete the mMRC scale. A complete medical history is collected. Subjects thereafter complete pulmonary function testing pre- and 30-min post-bronchodilator. Subjects are given a normal mixed meal and are asked not to drink alcohol or coffee. A symptom-limited incremental cycle exercise test is performed on the same day, at least 6 hours after the bronchodilator test and at least 4 hours after the meal. After a steady-state resting period, a 3-min warm-up is conducted at about 20% of individually estimated maximal work load (Wmax), and the load is increased every minute in such a way that the test duration is \>8 and \<12 min. The following data are obtained breath by breath and expressed as 30-s averages: V'O2 and carbon dioxide production (V'CO2); minute ventilation (V'E); tidal volume (VT); respiratory rate; and ventilatory equivalents for oxygen and carbon dioxide. Blood pressure is measured every minute by a sphygmomanometer. Blood samples are withdrawn from the arterialized earlobe at rest and at near-maximal exercise. Tests are terminated at the point of symptom limitation (peak exercise). Upon exercise cessation, subjects are asked to verbalize their main reason for stopping exercise (breathing discomfort, leg discomfort or both).

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
OTHER	Cardio-pulmonary exercise testing

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-08-01
• Completion: 2014-05-01
• First posted: 2014-09-09
• Last updated: 2014-09-09

Locations

1 site across 1 country: France