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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)
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
Details
| Lead sponsor | Université de Sherbrooke |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 150 |
| Start date | 2026-01-29 |
| Completion | 2030-01 |
Conditions
- Asthma Control
Interventions
- Dupilumab Prefilled Syringe
- Placebo Injection
Primary outcomes
- Win ratio based on remission criteria — Week 4 to Week 56 (except FEV1 change: Week 0 values serve as baseline)
Win ratio comparing patients achieving clinical remission outcomes in dupilumab group vs placebo group, based on remission criteria. The unmatched paired testing will follow this hierarchy: 1. Study participant has not had a severe asthma attack between weeks 4 and 56 2. Number of asthma attacks between weeks 4 and 56 3. Improved or stable lung function (defined as a decline from parent study baseline in pre- or postbronchodilator FEV1 by no more than 5%) at Week 56 4. No more than medium-dose ICS maintenance therapy (as defined by GINA 2025) at Week 56 5. 5-item Asthma Control Questionnaire mean score \<1.5 at Week 56
Countries
Australia, Canada, United Kingdom