Evaluation of the Response to Monoclonal Antibody Therapy in Severe Asthma: Research of Predictive Biomarkers in Exhaled Air

NCT ID: NCT03988790

Last Updated: 2021-02-16

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2022-12-31

Brief Summary

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This study evaluates the change in the composition of Volatil Organic Compounds (VOC) in patients treated by monoclonal antibody for severe asthma.

Detailed Description

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At least one in two patients treated by monoclonal antibody for severe asthma doesn't have satisfying result after 6 months of treatment.

The evaluation of the answer, and even better the answer prediction, are fundamental issues for medico-economic plan as part of these innovative therapeutics.

The interest of the use of VOC as diagnostic or prognostic tool in patients with tumoral thoracic pathology or bronchial or pulmonary vascular diseases has been demonstrated.

VOC analysis will be performed using two different techniques: electronic nose and masse spectrometry. At each visit, in addition to the usual assessment, patients will have two non-invasives collections of exhaled air, one for electronic nose analysis and one for masse spectrometry analysis.

Conditions

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Asthma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignement
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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VOC analysis

VOC analysis in exhaled air in patients with severe asthma treated by monoclonal antibody

Group Type EXPERIMENTAL

VOC analysis

Intervention Type DEVICE

VOC analysis in exhaled air with e-noses and mass spectrometry.

Interventions

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VOC analysis

VOC analysis in exhaled air with e-noses and mass spectrometry.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patient aged \> 18 years old
* patient with severe asthma who respond to the indication of monoclonal antibody therapy according to SPC and management criteria fixed by Transparency Committee
* signed informed consent
* patient with healthcare insurance

Exclusion Criteria

* patient not responding to the criteria for the good use of monoclonal antibody in severe asthma
* contraindication to one of monoclonal antibody treatment according to SPC (hypersensitivity to one of compounds)
* patient unable to perform a slow vital capacity
* patient with long-term oxygen therapy , under invasive ventilation
* pregnant women
* patient deprived of liberty by judicial or administrative decision
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Devillier

Role: PRINCIPAL_INVESTIGATOR

Pneumology department

Locations

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Hôpital Foch

Suresnes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Elisabeth Hulier-Ammar

Role: CONTACT

+33 1 46 25 11 75

Facility Contacts

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Philippe Devillier

Role: primary

+ 33 1 46 25 27 91

Other Identifiers

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2018_0075

Identifier Type: -

Identifier Source: org_study_id

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