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

Study acronym: HOTHOT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Secondary endpoints: details revised at 8 of 18 entries
    • Site details revised at 3 of 5 sites
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 2 words
  2. Minor Eligibility criteria expanded, about 10 wordsv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2026 to Jan 29, 2026
    • Site details revised at 5 of 5 sites
    v3
  4. Minor Re-verified, no change to tracked fieldsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07309614
Lead Sponsor Université de Sherbrooke
Collaborators: Sanofi, University of Oxford, The University of Western Australia, Regeneron Pharmaceuticals, Fonds de la Recherche en Santé du Québec, Association Pulmonaire du Quebec
Conditions
(from sponsor)
Asthma Control
Related terms Asthma
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov