LAVOLEX: Identification of Volatile Organic Compounds in Exhaled Air During Exacerbation of Chronic Obstructive Pulmonary Disease

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Terminated

CT.gov ID

NCT02529891

Collaborator

Aide à la Recherche Médicale Ondaine et Environs (Other)

Enrollment

Location

38.3

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Exacerbations of the disease are a hallmark of Chronic Obstructive Pulmonary Disease (COPD), affecting the decline of pulmonary function, quality of life and increasing morbidity. The use of validated biomarkers could help to identify the etiology of exacerbation and to prescribe antibiotherapy when indicated.

The analysis of exhaled air allows measuring different volatile organic compounds (VOC) which reflect local or systemic inflammation and oxidative stress. The relationship between the presence of some of these compounds and the exacerbation of COPD has never been studied.

The aim of this study is to identify a cluster of VOC in COPD patients during an acute exacerbation of the disease, compared to a stable condition (3 months after discharge). Investigators also will seek for a relationship between VOC and the etiology of exacerbation (bacterial, viral, inflammatory).

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Other: Measurement of VOC in exhaled air

Study Design

Study Type:

Observational

Actual Enrollment :

19 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Identification of Volatile Organic Compounds in Exhaled Air During Exacerbation of Chronic Obstructive Pulmonary Disease

Actual Study Start Date :

Aug 8, 2014

Actual Primary Completion Date :

Oct 17, 2017

Actual Study Completion Date :

Oct 17, 2017

Arms and Interventions

Arm	Intervention/Treatment
COPD Patients Patients with COPD, within 48h after hospital admission for exacerbation.	Other: Measurement of VOC in exhaled air Measurement of VOC in exhaled air during 10 min (tidal breathing) with a portable mass spectrometer
non-COPD patients Healthy person of the entourage of COPD patients.	Other: Measurement of VOC in exhaled air Measurement of VOC in exhaled air during 10 min (tidal breathing) with a portable mass spectrometer

Arm

Intervention/Treatment

COPD Patients

Patients with COPD, within 48h after hospital admission for exacerbation.

Other: Measurement of VOC in exhaled air

Measurement of VOC in exhaled air during 10 min (tidal breathing) with a portable mass spectrometer

non-COPD patients

Healthy person of the entourage of COPD patients.

Other: Measurement of VOC in exhaled air

Measurement of VOC in exhaled air during 10 min (tidal breathing) with a portable mass spectrometer

Outcome Measures

Primary Outcome Measures

Spectrum of VOC measured with a portable mass spectrometer system [Day 1 (within 48 hours after hospital admission for exacerbation of COPD)]
Spectrum of VOC in exhaled air in patients with COPD compared to those of control subjects. It is measured with a portable mass spectrometer system.

Secondary Outcome Measures

Variation in VOC spectrum in COPD patients measured with a portable mass spectrometer system [3 months after hospital discharge]
Variation in VOC spectrum in COPD patients during exacerbation and in stable condition (3 months later). It is measured with a portable mass spectrometer system.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria of COPD group:

COPD stages 2 and 3 of GOLD score (30 ≤ forced expiratory volume at one second (FEV1) < 80% of predicted value),
exacerbation confirmed clinically (increased dyspnea, cough or expectorations > 48 hours)

Inclusion Criteria of non COPD group:

No smoker (<100 cigarettes/year)

Exclusion Criteria of COPD group:

Diagnosis of COPD not confirmed.
Instable clinical status with respiratory failure and indication of mechanical ventilation.
Bronchodilator treatment changed
Antibiotic treatment started in the 10 last days before admission