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

Chronic Obstructive Pulmonary Disease Clinical Trial

— LAVOLEX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02529891
• Other study ID #: 1208090
• Secondary ID: 2012-A01072-41
• Status: Terminated
• Phase: N/A
• First received: August 19, 2015
• Last updated: October 17, 2017
• Start date: August 8, 2014
• Est. completion date: October 17, 2017

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: October 17, 2017
• Est. primary completion date: October 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Aide à la Recherche Médicale Ondaine et Environs

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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