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

NCT ID: NCT02235025

Last Updated: 2014-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-05-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Asymptomatic mild COPD

Subjects of this group have GOLD grade I COPD (post-bronchodilator FEV1 \> 80% predicted and FEV1/FVC \< 0.7). They also have a modified Medical Research Council (mMRC) score equal to zero and are free of respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze.

Group Type: OTHER

Cardio-pulmonary exercise testing

Intervention Type: OTHER

Symptomatic mild COPD

Subjects of this group have GOLD grade I COPD (post-bronchodilator FEV1 \> 80% predicted and FEV1/FVC \< 0.7). They also have a modified Medical Research Council (mMRC) score \> 0.

Group Type: OTHER

Cardio-pulmonary exercise testing

Intervention Type: OTHER

Healthy controls

Healthy controls have normal baseline spirometry (FEV1 \> 80% predicted, FEV1/FVC \> 0.7). They don't have any health problems, including cardiovascular, metabolic, neuromuscular, musculoskeletal, or respiratory diseases that could contribute to breathlessness or exercise limitation. They have a mMRC score equal to zero and do not complain any respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze and/or chronic respiratory related medication.

Group Type: OTHER

Cardio-pulmonary exercise testing

Intervention Type: OTHER

Interventions

Cardio-pulmonary exercise testing

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• For COPD groups: post-bronchodilator forced expiratory volume in 1 sec (FEV1) ≥ 80% predicted and a FEV1/forced vital capacity (FVC) ratio < 0.70
• For the "Asymptomatic mild COPD" group: modified Medical Research Council (mMRC) score equal to zero and absence of respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze.
• For the "Symptomatic mild COPD" group: mMRC) score > 0
• For the "Healthy controls" group: FEV1 > 80% predicted and FEV1/FVC > 0.7) and a mMRC score equal to zero and absence of respiratory symptoms including chronic cough and/or chronic expectoration and/or chronic wheeze
• Able to perform all study procedures and provide informed consent

Exclusion Criteria

• Presence of a medical condition other than COPD that could cause or contribute to breathlessness (i.e., a respiratory disease other than COPD and/or a metabolic and/or a cardiovascular disease)
• Presence of disorders other than COPD that could interfere with exercise testing, such as neuromuscular diseases or musculoskeletal problems
• History or clinical evidence of asthma
• Use of daytime oxygen or exercise-induced arterial oxygen desaturation to <80% on room air

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Degano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Besançon, France

Locations

Department of respiratory diseases

Besançon, , France

Countries

France

Other Identifiers

BAL-1

Identifier Type: -

Identifier Source: org_study_id