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

Asthma Clinical Trial

— Zina-VOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03988790
• Other study ID #: 2018_0075
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: Hopital Foch
• Contact: Elisabeth Hulier-Ammar
• Phone: +33 1 46 25 11 75
• Email: drci-promotion[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Volatil Organic Compound (VOC) profiles predictive of clinically significant response	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	1 day
Secondary	Change of FEV and FEV/CV	Predictive variations of a clinically relevant response with improvement of FEV and FEV/CV at 3, 6 and 12 months	change from baseline profiles at 3, 6 and12 months post-baseline
Secondary	Decrease of residual volume	Predictive variations of a clinically relevant response with decrease of residual volume (RV) at 3, 6 and 12 months	change from baseline profiles at 3, 6 and12 months post-baseline
Secondary	Decrease of the daily dose of oral corticosteroids	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	change from baseline profiles at 1, 3, 6 and12 months post-baseline
Secondary	Reduction in the number of exacerbations	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 from baseline profiles at 1, 3, 6 and12 months post-baseline
Secondary	Change before and after treatment	Change of Volatil Organic Compound (VOC) profiles before and after treatment whatever is the clinical answer	change from baseline profiles at 12 months post-baseline
Secondary	Change according to administered antibody	Change of Volatil Organic Compound (VOC) profiles according to administered antibody	1 day
Secondary	Volatil Organic Compound (VOC) profiles according to patients' phenotype	Volatil Organic Compound (VOC) profiles according to patients' phenotype at the inclusion	1 day