Actively Recruiting
REVErsing Airway Remodelling With Tezepelumab
Led by University Hospital, Montpellier · Updated on 2024-02-28
90
Participants Needed
12
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
REVErsing Airway Remodelling With Tezepelumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Able to perform inspiratory and expiratory thoracic CT scans and a nasal CT scan
- Stable condition suitable for CT scanning
- Physician-diagnosed asthma according to GINA criteria
- At least 1 severe or 2 moderate asthma exacerbations in the previous 12 months despite standard care
- Receiving maximal inhaled therapy including high-dose inhaled corticosteroids and at least one other controller
- Post-bronchodilator FEV1 between 25% and 90% of predicted values
- Asthma Control Questionnaire 6 (ACQ6) score greater than 1.5
- Oral corticosteroid maintenance therapy dose of 7.5 mg/day or less if used
- Average percentage wall area index on CT scan at B1 and B8 bronchi greater than 65%
You will not qualify if you...
- CT scan abnormalities suggesting respiratory conditions other than asthma
- Treatment regimen not aligned with best practices
- Pulmonary diseases other than asthma requiring treatment in the past 12 months
- Smoking history of more than 20 pack years
- Use of biologic or investigational agents within specified washout periods prior to randomization
- Prior participation in tezepelumab studies
- Lack of signed consent or non-beneficiary of French social security
- Any physical, psychological, or other condition hindering study participation
- Unavailability or unwillingness to attend future visits
- Participation in other clinical studies that may interfere
- Protected populations under French public health code
- Patients seeking to conceive or fertile women and men not using contraception
- Pregnant, breastfeeding, or lactating women
- Recent or serious infections requiring antibiotics or antivirals within 2 weeks before randomization
- Untreated or unresponsive helminth parasitic infection within 6 months
- Use of vaping products
- Bronchial thermoplasty within 12 months prior to screening
- History of immune complex disease following biologic therapy
- Known immunodeficiency including HIV or use of antiretroviral medications
- Use of T2 cytokine inhibitor Suplatast tosilate within 15 days prior to randomization
- Recent treatment with systemic immunosuppressive or immunomodulating drugs within 12 weeks prior to randomization
- Receipt of immunoglobulin or blood products within 30 days prior to randomization
- Unstable or changing allergen immunotherapy within 30 days prior to randomization
AI-Screening
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Trial Site Locations
Total: 12 locations
1
CHU Dijon
Dijon, France
Actively Recruiting
2
CHU Grenoble Alpes La Tronche
Grenoble, France
Actively Recruiting
3
APHP Bicêtre
Le Kremlin-Bicêtre, France
Actively Recruiting
4
CHRU Lille
Lille, France
Withdrawn
5
Hôpital de la Croix Rousse
Lyon, France
Actively Recruiting
6
Hôpital Nord Marseille
Marseille, France
Actively Recruiting
7
CHU de Montpelier
Montpellier, France
Actively Recruiting
8
APHP Bichat
Paris, France
Actively Recruiting
9
Hôpital Foch
Paris, France
Actively Recruiting
10
Hôpital Haut-Lévêque
Pessac, France
Actively Recruiting
11
CHRU Strasbourg
Strasbourg, France
Actively Recruiting
12
CHU Toulouse
Toulouse, France
Actively Recruiting
Research Team
A
Arnaud Bourdin, MD
CONTACT
F
Fanny Cardon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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