A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
A Multinational, Investigator-initiated, Parallel Group, Randomised, Double-blind, Placebo-controlled Phase 3b Superiority Trial Assessing the Effect of Dupilumab on Inducing Clinical Remission Outcomes in At-risk Type-2 Inflammatory Asthma (HOTHOT)
Université de Sherbrooke
150 participants
Jan 29, 2026
INTERVENTIONAL
Conditions
Summary
This study tests whether an asthma medication called dupilumab can help people achieve complete asthma control (called "remission") when given earlier in their disease, before asthma becomes severe. Currently, most people with asthma only receive advanced treatments like biologics after their condition has worsened significantly and caused lung damage. This study explores whether treating high-risk patients earlier could prevent asthma attacks and lung function decline, potentially achieving remission before permanent damage occurs. The study is looking for adults aged 18-79 with moderate asthma who have had at least one asthma attack requiring steroid pills in the past 2 years, use medium or high-dose inhaled steroids regularly, have high levels of inflammation markers in their blood and breath tests, but don't yet meet criteria for severe asthma requiring biologic therapy. Participants receive either dupilumab or placebo injections every 2 weeks for one year, alongside their regular asthma medications. They attend clinic visits every 3 months for breathing tests, questionnaires, and safety monitoring. Neither participants nor doctors know who receives the real medication until the study ends. The goal is to learn whether early treatment with dupilumab helps more people achieve complete asthma control compared to standard care alone, potentially changing how asthma is treated from "waiting until severe" to "preventing severe disease." The study runs in Canada, the United Kingdom, and Australia, involving 150 participants
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Dupilumab 400mg subcut x1 followed by 200mg subcut every 2 weeks
Volume-matched placebo injected subcut every 2 weeks
Locations(5)
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For the most up-to-date information, visit the official listing.
NCT07309614