A Multinational, Investigator-initiated, Randomised, Double-blind, Placebo-controlled Trial Assessing Dupilumab for Inducing Clinical Remission in At-risk Type-2 Inflammatory Asthma

What this Trial Is About

Researchers are evaluating whether an asthma medication called dupilumab can help adults with moderate asthma achieve complete asthma control, known as remission, by treating them earlier in their disease before it becomes severe. The study focuses on adults aged 18 to 79 who have had at least one asthma attack needing steroid pills in the past two years, use medium or high-dose inhaled steroids regularly, and have high inflammation markers in blood and breath tests but do not yet require severe asthma biologic treatments. The goal is to see if early treatment with dupilumab can prevent asthma attacks and lung decline, potentially changing asthma care from reactive to proactive. Participants receive either dupilumab or placebo injections under the skin every two weeks for one year while continuing their usual asthma medicines. Both groups follow traditional inhaled corticosteroid dose adjustments based on symptoms during this period. The study is double-blind, so neither participants nor doctors know who receives dupilumab or placebo until the study ends. The main measure compares the chances of achieving remission over 56 weeks, with additional measures assessing asthma attacks, lung function, symptom control, and quality of life. During the study, participants attend clinic visits every three months for lung function tests, questionnaires, and safety checks. Researchers monitor inflammation markers and medication use throughout the year to evaluate treatment effects. The study involves 150 participants across Canada, the United Kingdom, and Australia, aiming to provide evidence for earlier use of dupilumab in people at risk of severe asthma.

A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma