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

Not Applicable

• Conditions: Asthma
• Interventions: Device: VOC analysis

• Registration Number: NCT03988790
• Lead Sponsor: Hopital Foch

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-12-04
• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-17
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-16
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change of Volatil Organic Compound (VOC) profiles predictive of clinically significant response	1 day	Clinically significant response defined by: * reduction of 50% of number of exacerbations treated by oral corticosteroids after 12 months of treatment compared to the number of exacerbation during the previous year AND/OR; * increase of 3 points (MCID according to Schartz and al 2009) of ACT score after 3 months of treatment and maintained at 6 months

Secondary Outcome Measures

Name	Time	Method
Decrease of residual volume	change from baseline profiles at 3, 6 and12 months post-baseline	Predictive variations of a clinically relevant response with decrease of residual volume (RV) at 3, 6 and 12 months
Volatil Organic Compound (VOC) profiles according to patients' phenotype	1 day	Volatil Organic Compound (VOC) profiles according to patients' phenotype at the inclusion
Change of FEV and FEV/CV	change from baseline profiles at 3, 6 and12 months post-baseline	Predictive variations of a clinically relevant response with improvement of FEV and FEV/CV at 3, 6 and 12 months
Change before and after treatment	change from baseline profiles at 12 months post-baseline	Change of Volatil Organic Compound (VOC) profiles before and after treatment whatever is the clinical answer
Decrease of the daily dose of oral corticosteroids	change from baseline profiles at 1, 3, 6 and12 months post-baseline	Predictive variations of a clinically relevant response with decrease of the daily dose of oral corticosteroids for corticosteroid-dependent patients at 1, 3, 6 and 12 months
Reduction in the number of exacerbations	change from baseline profiles at 1, 3, 6 and12 months post-baseline	50% reduction in the number of exacerbations treated with oral steroids after 6 months of treatment compared to the number of exacerbations in the previous year OR a 3 point increase in the ACT (Asthma Control Test) score after 3 months of treatment maintained at 6 months OR increase of GETE (global evaluation of treatment effectiveness) score at 1, 3, 6 and 12 months
Change according to administered antibody	1 day	Change of Volatil Organic Compound (VOC) profiles according to administered antibody

Trial Locations

Locations (1)

Hôpital Foch; 🇫🇷 Suresnes, France