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

NCT03988790 | Unknown

• 1 other identifier: 2018_0075
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change of FEV and FEV/CV

  change from baseline profiles at 3, 6 and12 months post-baseline

• Decrease of residual volume

  change from baseline profiles at 3, 6 and12 months post-baseline

• Decrease of the daily dose of oral corticosteroids

  change from baseline profiles at 1, 3, 6 and12 months post-baseline

• Reduction in the number of exacerbations

  change from baseline profiles at 1, 3, 6 and12 months post-baseline

• Change before and after treatment

  change from baseline profiles at 12 months post-baseline

Study Arms (1)

VOC analysis

EXPERIMENTAL

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

Device: VOC analysis

Interventions

VOC analysis DEVICE

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

VOC analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Philippe Devillier

  Pneumology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth Hulier-Ammar

CONTACT

+33 1 46 25 11 75; drci-promotion@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignement

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 17, 2019
• Study Start: December 4, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

FR (1)