Below is an overview of the ongoing and terminated CRISALIS projects. You will also find on this page an access to the ELIGIBILITEST tool which allows to test the eligibility of severe asthmatic patients to ongoing trials.
ELIGIBILITEST
The ELIGIBILITEST tool has been developed by Dr Laurie Pahus, AP-HM Marseille.
It aims to facilitate the screening of severe asthmatic patients in clinical trials and registries open to recruitment.
A tab allows to test the eligibility from the main inclusion and exclusion criteria used for severe asthma studies (age, FEV1, reversibility to bronchodilators, smoking...). Access is then given to the detailed criteria of each study. You will also find the contact details of the CRISALIS centers if you have any questions about these studies.
This tool has been designed to boost recruitment in the studies supported by CRISALIS, particularly by facilitating the referral of patients seen in hospital centers outside the network and by freelance pulmonologists; do not hesitate to use it!
👉 Access the tool (V3.1, French) 👈 (Excel file to download, click 'Activate modifications' and 'Activate content')
Do not hesitate to give us feedback on the tool, by email (contact@crisalis-network.org) or using the contact form.
The file will be updated regularly through a solicitation of the network members concerning new studies or completion of others.
Ongoing projects
BENRAPRED
- Initiated by Prof Magnan (Nantes University Hospital, now Foch Hospital), coordinated by Prof Blanc (Nantes University Hospital)
- Multicenter, non-controlled, non-randomized Phase IV study
- Objective: To establish the value of a blood gene expression signature predictive of therapeutic response to Benralizumab in severe asthmatic patients
- Sponsor: Nantes University Hospital
- Funding: PHRC-N and AstraZeneca
- Regulatory approvals: obtained in 2020
- Centers: 16, among which 13 CRISALIS centers
- Recruitment ended (objective of 220 patients: unreached), patient follow-up is ongoing
BOA
- Initiated by Prof Guilleminault (Toulouse University Hospital)
- Phase IV multicenter, randomized, controlled study
- Objective: to study the effect of intragastric balloons on asthma control in uncontrolled severe obese asthmatic subjects
- Sponsor: Toulouse University Hospital
- Funding: PHRC-I
- Regulatory authorizations: obtained in 2022
- Centers: 4, among which 3 CRISALIS centers
- Ongoing study, open to recruitment
COBRA
- Initiated by Bordeaux University Hospital - coordinating investigator: Prof Maéva Zysman, CRISALIS referent investigator: Prof Patrick Berger
- Prospective national cohort of asthma and COPD patients, associated with a biobank, 10-year follow-up of patients
- Objective: to evaluate the evolution of biomarkers involved in the severity of asthma (proteomics) and to determine the genetic risk factors.
- Sponsor: INSERM
- INSERM mixed funding
- Regulatory authorizations: obtained
- Centers: 21, among which 13 CRISALIS centers
- Ongoing study, open to recruitment
PALOMB Asthme Sévère
- Initiated by CRISALIS coordinating investigator: Pr Raherison-Semjen (Bordeaux University Hospital, now Guadeloupe University Hospital)
- Observatory of patients with severe asthma
- Sponsor: Bordeaux University
- Funding: industrial
- Centers: 18, among which 3 CRISALIS centers (Toulouse, Bordeaux, Pointe-à-Pitre)
- Ongoing study, open to recruitment
- More info
PREDICTUMAB
- Multinational study initiated by Prof Pilette (UCL Louvain, Belgium)
for France: initiated by Prof Devouassoux (Lyon University Hospital) and Prof Bourdin (Montpellier University Hospital) - Phase IV, multinational, open-label, randomized, controlled study
- Objective: to compare the response to omalizumab and mepolizumab in severe asthmatic patients with allergic and eosinophilic phenotype
- International sponsor: UCL Leuven, Belgium
- Delegation of promotion in France: HCL
- Funding: IMI 3TR
- Regulatory authorizations: obtained in 2020
- Centers in France: the 16 CRISALIS centers
- Recruitment ended (objective of 340 patients: unreached), patient follow-up is ongoing
RAMSES
- Initiated by the CRISALIS coordinating investigator: Prof Taillé (APHP Bichat)
- Cohort / National prospective registry of adult patients with severe asthma
- Objective: To have longitudinal data allowing the realization of studies on the characteristics of the patients, the modalities of their management, the benefits and/or the associated risks
- Sponsor: APHP
- Learned society : SPLF
- Funding: industrial, academic, institutional
- Regulatory authorizations: obtained
- Centers: 40, among which 12 CRISALIS centers
- Recruitment ended (objective of 2000 patients: reached), patient follow-up is ongoing
REVERT
- Initiated by the CRISALIS coordinating investigator: Prof Bourdin (CHU Montpellier)
- Prospective multi-center Randomized, Controlled, Placebo-controlled, Double-blind Drug Study (Phase III)
- Objective: Evaluate the reversibility of airway remodeling under tezepelumab in severe asthmatics.
- Sponsor: University Hospital of Montpellier
- Funding: industrial
- Regulatory approvals: obtained in 2022
- Centers: 12 CRISALIS centers
- Recruitment ended (objective of 90 patients: reached), patient follow-up is ongoing
SHORTEN
- Initiated by the CRISALIS coordinating investigator: Prof Taillé (APHP, Bichat)
- Multicenter, open-label, randomized, controlled, non-inferiority Phase IV study in 2 parallel groups
- Objective: Impact of Omalizumab discontinuation after 3 years of treatment in well controlled severe allergic asthma
- Sponsor: APHP
- Funding: PHRC-N 2018
- Regulatory authorizations: obtained
- Centers: 41, among which 13 CRISALIS centers
- Ongoing study, open to recruitment
TEXAS
- Initiated by the CRISALIS coordinating investigator: Prof Chenivesse (CHRU Lille)
- RIPH2 study, multicenter, open label
- Objective: Evaluate the change in physical activity after 6 months of treatment with Mepolizumab in severe asthmatics.
- Sponsor: CHRU of Lille
- Funding: industrial
- Regulatory approvals: obtained in 2022
- Centers: 11, among which 9 CRISALIS centers
- Recruitment and follow-up ended, analysis is ongoing
WIDUSA
- Initiated by the CRISALIS coordinating investigator: Pr Guilleminault (Toulouse University Hospital)
- Non-inferiority randomized controlled trial
- Objective: to demonstrate the non-inferiority of stopping dupilumab versus continuing it in severe asthma patients who have been treated for at least 3 years
- Sponsor: Toulouse University Hospital
- Funding: PHRC-N 2023
- Regulatory approvals: obtained in January 2025
- Centers: 31, among which 14 CRISALIS centers
- Ongoing study, open to recruitment
Terminated projects
ASFAC
- Initiated by the CRISALIS coordinating investigator: Prof Guilleminault (Toulouse University Hospital), implemented in collaboration with the team of Prof Agnès Sommet (Pharmacoepidemiology, CIC 1436, Toulouse University Hospital-Inserm) and the UEME with the team of Dr Nadège Costa
- Epidemiological study on health data (SNDS, CépiDC)
- Objective: Describe the characteristics, the care pathway and the therapeutic management of asthma patients who died of asthma in France between 2013 and 2017
- Sponsor: Toulouse University Hospital
- Funding: AstraZeneca
- Regulatory authorizations: obtained
- Started in 2020, Analysis and Valorization in 2022
- Valorization: clinical publication & medico-economic publication
ASTHMIRINE
- Initiated by the CRISALIS coordinating investigator: Prof Taillé (APHP, Bichat)
- Phase IV multicenter, randomized, placebo-controlled study
- Objective: Interest of a prolonged treatment with aspirin in uncontrolled asthma
- Sponsor: APHP
- Financing: PHRC-N
- Regulatory authorizations: obtained
- Centers: CRISALIS + University Hospitals of Rouen and Nancy
- Recruitment suspended, study closed
CATAPLASTHMA
- Initiated by the CRISALIS Besançon center - scientific director: Dr Lucie Laurent, CRISALIS coordinating investigator: Pr Cindy Barnig
- Objective: characterize the psychological profile of severe asthma patients using questionnaires
- Sponsor: Besançon University Hospital
- Mixed funding
- Regulatory approvals: obtained in 2022
- Centers: 3 CRISALIS centers (Besançon, Reims, Bichat)
- Recruitment ended (objective of 230 patients: reached)
- Analysis in progress
ENQUÊTE 2nd SOUFFLE
- Initiated by the CRISALIS coordinating investigator: Prof Didier (Toulouse University Hospital)
- Prospective study on data collected through surveys
- Objective: Evaluation of the care pathway and the quality of life of patients suffering from severe asthma in France according to their phenotype
- Sponsor: Toulouse University Hospital
- Funding: AstraZeneca
- Regulatory authorizations: obtained in 2020
- Centers: 31 centers including CRISALIS centers + University Hospital + General Hospital + private individuals
- July 2020 - July 2021
- Recruitment ended (objective reached)
- Valorization: publication
ENQUÊTE TERRAIN - PASS, Parcours Asthme Sévère Sécurisé
- Initiated by the CRISALIS coordinating investigator: Prof Didier (Toulouse University Hospital)
- Field survey on site in partnership with Ed'Innov Santé
- Objectives: 1. to identify the care pathway of asthma patients going to the emergency room in all French health care institutions wishing to participate, highlighting in each center the strong points and areas for improvement 2. To model this pathway by summarizing the strengths and areas for improvement of this pathway after consultation.
- Sponsor: NA
- Institutional support: GSK
- Centers: initiated in 12 CRISALIS centers, extended to other voluntary health institutions
- July 2019 - December 2021
- Valorization: publication
PRESATHMA
- Initiated by the CRISALIS coordinating investigator: Prof Chenivesse (CHRU Lille)
- Observational study with questionnaires
- Objective: Identify the factors associated with the evolution of presenteeism under biotherapy in severe asthma
- Sponsor: Lille University Hospital
- Funding: industrial
- Regulatory authorizations: obtained
- Centers: 15, among which 10 CRISALIS centers
- Recruitment ended (objective reached)
- Valorization: publication
SECURE
- Initiated by the CRISALIS coordinating investigator: Prof Devouassoux (Lyon University Hospital)
- Phase IV, multicenter, open-label, randomized, controlled study (ex Cat RIPH 2 / - human drug / low intervention trial, European regulation)
- Objective: Evaluate symptom control and compliance with Mepolizumab treatment administered with different devices: compare self-injection via pre-filled syringe vs. self-injector pen vs. syringe administered by a nurse
- Sponsor: Lyon University Hospital (HCL)
- Funding: industrial
- Regulatory authorizations: obtained in 2022
- Centers in France: 8 CRISALIS centers
- Recruitment suspended, study closed
Participation in studies
For more information about any of our studies, you can contact us.
