An international clinical trial involving the University of Oxford which aims to use an innovative new approach to tackle moderate asthma has been launched thanks to a 10 million Canadian dollars grant from the biopharmaceutical company Sanofi and its partner Regeneron.
The HOTHOT trial, which will be led by the Université de Sherbrooke (UdeS) in Canada, involves Oxford scientists supported by the NIHR Oxford Biomedical Research Centre (BRC), as well as the Institute for Respiratory Health in Western Australia.
In the UK, the study will be led by Chief Investigator Professor Nayia Petousi, Associate Professor in the Nuffield Department of Medicine and Consultant Respiratory Physician specialising in severe asthma, supported by the Oxford BRC. The trial will also be supported by the Oxford Respiratory Trials Unit.
Professor Petousi commented: “This is tremendous news. We hope the trial will help shift thinking in the field, enabling early identification of high-risk disease and the use of impactful therapies earlier in the patient journey.”
The goal of the trial is to transform the treatment of moderate asthma, a disease that afflicts over 300 million people around the world.
The researchers will evaluate an anti-inflammatory drug called dupilumab (Dupixent®), developed by Sanofi and Regeneron. Dupilumab, an injectable biologic medication, has already been approved for a number of diseases caused by underlying type-2 inflammation, which is an overreaction of the immune system.
The goal is to recruit 150 patients – 50 each in the United Kingdom, Australia and Quebec – to see if their asthma can be induced into remission. While only 30% of severe-asthma patients who receive biologics experience remission, researchers hope that their strategy of treating moderate- to high-risk asthma cases early and proactively will raise this proportion to 50%.
It is hoped that the data, samples and results produced during the study will open other research avenues and allow greater understanding of this major disease.
The Principal Investigator for the trial is UdeS respiratory professor Simon Couillard, who is affiliated with the University of Oxford and has received support from the Oxford BRC.
He said: “The HOTHOT study is the culmination of long years of research to identify – and now treat – patients with high-risk reactive airway disease. It will also be the first asthma study to aim for remission as a primary outcome.
“I am extremely proud of and grateful for the commitment of all the project partners and contributors, who have worked very hard to ensure this study could be carried out in Sherbrooke.”