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

NCT ID: NCT02529891

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-08

Study Completion Date

2017-10-17

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Chronic Obstructive Pulmonary Disease COPD Volatile Organic Compounds Exacerbation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD Patients

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

Measurement of VOC in exhaled air

Intervention Type OTHER

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.

Measurement of VOC in exhaled air

Intervention Type OTHER

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

Interventions

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Measurement of VOC in exhaled air

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aide à la Recherche Médicale Ondaine et Environs

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederic COSTES, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

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CHU de SAINT-ETIENNE

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2012-A01072-41

Identifier Type: OTHER

Identifier Source: secondary_id

1208090

Identifier Type: -

Identifier Source: org_study_id