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REVErsing Airway Remodelling With Tezepelumab
Sponsor: University Hospital, Montpellier
Summary
The aim of this protocol is to perform a first randomized controlled trial evaluating how Tezepelumab affects the bronchial morphology (and computed tomographic variables in general) of asthmatic patients. In parallel, the investigators also hope to reproduce clinical benefits and perform a transcriptomic study that will juxtapose changes in genetic expression with changes in bronchial morphology and inflammatory signatures. The general hypothesis is that tezepelumab treatment is capable of at least partially reversing bronchial remodelling as detected on computed-tomographic (CT) scans. The investigators also expect such reversal to occur within a unique physiological repair environment that will be reflected by transcriptomic profiles
Official title: REVErsing Airway Remodelling With Tezepelumab : a Protocol for a Double-blind Randomized Controlled Trial for Patients With Asthma
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-03-27
Completion Date
2026-06-01
Last Updated
2024-02-28
Healthy Volunteers
No
Conditions
Interventions
Tezepelumab
Tezepelumab is supplied as a sterile, single-use, preservation-free, clear, colourless to slightly yellow liquid for subcutaneous administration in accessorized pre-filled syringes (APFS). Injections will be performed by study staff (doctors or nurses) during face-to-face study visits in participating centres. Subcutaneous injections are performed in a different body-part following the suggested rotation diagram.
placebo
APFS containing analogous placebo identical in appearance: Injections will be performed by study staff (doctors or nurses) during face-to-face study visits in participating centres. Subcutaneous injections are performed in a different body-part following the suggested rotation diagram.
Locations (12)
CHU Dijon
Dijon, France
CHU Grenoble Alpes La Tronche
Grenoble, France
APHP Bicêtre
Le Kremlin-Bicêtre, France
CHRU Lille
Lille, France
Hôpital de la Croix Rousse
Lyon, France
Hôpital Nord Marseille
Marseille, France
CHU de Montpelier
Montpellier, France
APHP Bichat
Paris, France
Hôpital Foch
Paris, France
Hôpital Haut-Lévêque
Pessac, France
CHRU Strasbourg
Strasbourg, France
CHU Toulouse
Toulouse, France