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

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).

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Measurement of VOC in exhaled air

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with exacerbation of COPD and Healthy volonteers

Description

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

Exclusion Criteria of non COPD group:

• Chronic inflammatory disease
• Any respiratory disease
• Oral corticosteroid treatment during the last month

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spectrum of VOC measured with a portable mass spectrometer system	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.	Day 1 (within 48 hours after hospital admission for exacerbation of COPD)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation in VOC spectrum in COPD patients measured with a portable mass spectrometer system	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.	3 months after hospital discharge

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Aide à la Recherche Médicale Ondaine et Environs
• Investigators: Principal Investigator: Frédéric COSTES, MD PhD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2014
• Primary Completion (Actual): October 17, 2017
• Study Completion (Actual): October 17, 2017

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (Estimate): August 20, 2015

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease; Exacerbation; Volatile Organic Compounds
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 1208090; 2012-A01072-41 (Other Identifier: ANSM)