Two Clinical Trials on Asthma Conducted by Sanofi Are Authorized in a Record Median Time of 6.7 Weeks at the CHUS, With the Support of the Fast Track Evaluation Service
Sanofi used CATALIS’ FAST TRACK Evaluation Service for two Phase II studies, AIRCULES and AIRLYMPUS, focusing on asthma.
The research team led by Dr. Simon Couillard of the Centre for Research at the Centre Hospitalier de l’Université de Sherbrooke (CRCHUS) obtained authorization for these two studies in record time: 6.8 weeks for the AIRCULES study and 6.6 weeks for the AIRLYMPUS study.
“Sanofi is proud to see the exceptional results achieved through the FAST TRACK Evaluation Service of CATALIS for our AIRCULES and AIRLYMPUS studies. With record authorization times of 6.8 and 6.6 weeks, respectively, this collaboration demonstrates the remarkable efficiency of the FAST TRACK evaluation process in Quebec. This strategic partnership not only accelerates the development of innovative treatments for asthma patients but also positions Quebec as a global leader in clinical asthma research.”
– Jean-François Léger, Site Partnership Manager, Clinical Research Unit, Sanofi Canada
“As a young clinical researcher, benefiting from the support and process of the CATALIS’ FAST TRACK Evaluation Service for the AIRCULES and AIRLYMPUS studies allowed me to maximize recruitment opportunities for patients. The CATALIS team was professional and efficient, and I now approach every potential clinical study with the request that it be supported by CATALIS.”
– Simon Couillard-Castonguay MD, Professor, Faculté de médecine et des sciences de la santé (FMSS), Université de Sherbrooke, Clinician-Researcher, CRCHUS, CIUSSS de l’Estrie – CHUS
Dr. Simon Couillard-Castonguay, who leads both studies with his team and aims to better diagnose and treat respiratory diseases, is a pulmonologist, clinician-researcher at CRCHUS, and director of the Respiratory Health Research Chair of the Quebec Lung Association. The chair he leads at CHUS is dedicated to advancing knowledge on the inflammation of respiratory diseases and enabling patients to benefit from new treatments.
“Asthma Canada is pleased with the success of CATALIS’ FAST TRACK Evaluation Service, which allowed a clinical trial to be authorized within an impressive six weeks. The unprecedented efficacy and speed with which this study was approved testify to the remarkable work carried out by the CATALIS team. As a member of the CATALIS patient organization Network, we encourage participation in clinical trials in Canada and fully support the work of the FAST TRACK Evaluation Service to make Quebec a leading and welcoming environment for studies on the global market.”
– Jeffrey Beach, President and CEO Asthma Canada
A Targeted Treatment With the Potential to Improve Asthma Control
Asthma is a chronic respiratory disease characterized by inflammation and narrowing of the pulmonary tract, which makes breathing difficult. These attacks may be triggered by allergens, exercise, stress or environmental irritants. In Quebec, the number of asthmatics is estimated to be 960,000, and this figure increases each year, due to the deterioration in air quality, by pollution, and climate changes that prolong the pollen season¹. The two Sanofi’s FAST TRACK studies address this growing issue.
The Phase II AIRCULES study², which plans to recruit 630 participants worldwide, including 4 at the CHUS, aims to determine the effects of an investigational drug in people who have moderate to severe asthma that is not well controlled.
The Phase II AIRLYMPUS study³, which plans to recruit 488 participants worldwide, including 3 at the CHUS, evaluates the effects of the same experimental drug as the AIRCULES study, but includes individuals with mild to moderate asthma, accompanied by recurrent exacerbations requiring more intensive treatment.
Innovation for the Benefit of Patients: The Catalis Network Reduces Clinical Trial Authorization Timelines
Thanks to the commitment of the CHUS and Sanofi, CATALIS and its Network of Partners are delighted to stimulate innovation in clinical research and reduce clinical trials’ authorization times by nearly 75%, with the goal of accelerating the development of innovative treatments that improve the lives of patients in Quebec.
CATALIS would like to thank all its public and private partners for their trust, their participation in developing innovative clinical research approval methods, and their commitment to implementing accelerated clinical trials in their institutions.
If you would like more information about the FAST TRACK Evaluation Service, please write to us at: info@catalisquebec.com.
- Association pulmonaire du Québec (2024). Asthme : diagnostic, traitements et gestion. Available on: https://poumonquebec.ca/maladie/asthme/
- ClinicalTrials.gov (n.d.). NCT06102005 Study. Available on: https://clinicaltrials.gov/study/NCT06102005?term=NCT06102005&rank=1
- ClinicalTrials.gov (n.d.). NCT06676319 Study. Availaible on: https://clinicaltrials.gov/study/NCT06676319?term=NCT06676319%20&rank=1
