REVErsing airway Remodelling with Tezepelumab (REVERT)

Phase 1

• Conditions: exacerbating asthma; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2022-002891-35-FR
• Lead Sponsor: niversity Hospital of Montpellier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Admitted to screening visit:
•Minimum age: 18
•Maximum age: 85
•Able to perform an inspiratory and expiratory thoracic computed tomography (CT) scan, plus a nasal CT
•Physician-diagnosed asthma according to GINA criteria
•Disease with clinical impact: at least 1 severe or 2 moderate exacerbations† in the previous 12 months despite treatment according to the best standards of care
•Maximal inhaled therapy comprising high dose ICS and at least a second controller according to GINA

Based on results of screening visit and run-in:
•Post-bronchodilator forced expiratory volume in 1 second (FEV1) predicted values must be at 25-90%
•Asthma Control Questionnaire 6 (ACQ6) > 1.5
•Oral corticosteroid maintenance therapy (if used) is ?7.5 mg/day
•In stable condition for the 4-week run-in period
•On CT scan, the average percentage wall area index at the B1 and B8 bronchi (generation 3) is >65%

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

•CT abnormalities evocative of any respiratory condition other than asthma‡
•Treatment regimen discordant with best practices
•Pulmonary disease other than asthma‡ requiring treatment during the previous 12 months
•A smoking history of >20 pack years
•Biological therapy§ during the past 3 months
•Absence of signed consent
•Non-beneficiary of the French social security, single-payer health insurance system
•Presence of any condition (physical, psychological or other) that might, in the investigator’s opinion, hinder study performance††
•The patient is unavailable or unwilling to participate in future visits
•Potential interference from other studies‡‡
•Protected populations according to the French public health code§§
•Male or female patients seeking to conceive a child

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified