REVErsing airway Remodelling with Tezepelumab (REVERT): a protocol for a double-blind randomized controlled trial for patients with asthma - REVERT

niversity Hospital of Montpellier0 个研究点目标入组 90 人开始时间: 2024年4月9日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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

•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

发起方

niversity Hospital of Montpellier