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

NCT02529891 | Terminated

• 2 other identifiers: 12080902012-A01072-41
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Volatile Organic Compounds; Exacerbation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Variation in VOC spectrum in COPD patients measured with a portable mass spectrometer system

  3 months after hospital discharge

Study Arms (2)

COPD Patients

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

Other: Measurement of VOC in exhaled air

non-COPD patients

Healthy person of the entourage of COPD patients.

Other: Measurement of VOC in exhaled air

Interventions

Measurement of VOC in exhaled air OTHER

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

COPD Patients; non-COPD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with exacerbation of COPD and Healthy volonteers

You may qualify if:

• 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)
• No smoker (\<100 cigarettes/year)

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Aide à la Recherche Médicale Ondaine et Environs: collaborator

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Frederic COSTES, MD PhD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 20, 2015
• Study Start: August 8, 2014
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

FR (1)