Study of dupilumab for remission in at-risk type-2 inflammatory asthma (HOTHOT)
Research type
Research Study
Full title
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)
IRAS ID
1013033
Contact name
Nayia Petousi
Contact email
Sponsor organisation
Universite de Sherbrooke
Research 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 we treat asthma from "waiting until severe" to "preventing severe disease." The study runs in Canada, the United Kingdom, and Australia, involving 150 participants.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
26/LO/0373
Date of REC Opinion
15 Jun 2026
REC opinion
Further Information Favourable Opinion