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

NCT02235025 | Completed DMC

• 1 other identifier: BAL-1
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

mild COPD; dyspnea; exercise; respiratory mechanics

Outcome Measures

Primary Outcomes (1)

• Dyspnea intensity measured by the 10-point Borg scale during cycle exercise

  Dyspnea intensity is measured at rest and every two minutes thereafter. Dyspnea intensity at 80% of maximal predicted work rate is calculated by linear interpolation between adjacent measurement points for each subject

  up to 12 minutes

Secondary Outcomes (2)

• Inspiratory capacity

  up to 12 minutes

• Tidal volume as a function of minute ventilation

  up to 12 minutes

Study Arms (3)

Asymptomatic mild COPD

OTHER

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.

Other: Cardio-pulmonary exercise testing

Symptomatic mild COPD

OTHER

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.

Other: Cardio-pulmonary exercise testing

Healthy controls

OTHER

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.

Other: Cardio-pulmonary exercise testing

Interventions

Cardio-pulmonary exercise testing OTHER

Asymptomatic mild COPD; Healthy controls; Symptomatic mild COPD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Department of respiratory diseases

Besançon, 25000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Bruno Degano, MD, PhD

  CHU Besançon, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 9, 2014
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: May 1, 2014
• Last Updated: September 9, 2014

Record last verified: 2014-08

Locations

FR (1)