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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    50
  • sponsor
    Hopital Foch
Updated on 21 February 2021

Summary

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

Description

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.

Details
Condition Asthma, Allergies & Asthma, Asthma (Pediatric), asthmatic, bronchial asthma
Treatment VOC analysis
Clinical Study IdentifierNCT03988790
SponsorHopital Foch
Last Modified on21 February 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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