Evaluation of the Response to Monoclonal Antibody Therapy in Severe Asthma: Research of Predictive Biomarkers in Exhaled Air (Zina-VOC)

February 15, 2021 updated by: Hopital Foch

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: VOC analysis
VOC analysis in exhaled air in patients with severe asthma treated by monoclonal antibody
Device: VOC analysis
VOC analysis in exhaled air with e-noses and mass spectrometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Volatil Organic Compound (VOC) profiles predictive of clinically significant response
Time Frame: 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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of FEV and FEV/CV
Time Frame: 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 from baseline profiles at 3, 6 and12 months post-baseline
Decrease of residual volume
Time Frame: 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
change from baseline profiles at 3, 6 and12 months post-baseline
Decrease of the daily dose of oral corticosteroids
Time Frame: 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
change from baseline profiles at 1, 3, 6 and12 months post-baseline
Reduction in the number of exacerbations
Time Frame: 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 from baseline profiles at 1, 3, 6 and12 months post-baseline
Change before and after treatment
Time Frame: 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
change from baseline profiles at 12 months post-baseline
Change according to administered antibody
Time Frame: 1 day
Change of Volatil Organic Compound (VOC) profiles according to administered antibody
1 day
Volatil Organic Compound (VOC) profiles according to patients' phenotype
Time Frame: 1 day
Volatil Organic Compound (VOC) profiles according to patients' phenotype at the inclusion
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 4, 2018

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (ACTUAL)

June 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018_0075

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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