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NCT07574294Completed

Dual REmission in Moderate-to-SEvere asthMa and Nasal Polyps

Dual Remission in Patients With Moderate-to-Severe Asthma and CRSwNP Treated With Dupilumab: A 24-Month Real-World Study

Source: ClinicalTrials.gov · Last updated 7 May 2026

Brief summary (registry, in English)

Background: "Remission" is a primary therapeutic goal in severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), though definitions vary regarding olfactory function. We evaluated "Dual Remission" kinetics in patients treated with dupilumab over 24 months. Methods: This single-center retrospective study analyzed 28 patients with comorbid severe asthma and CRSwNP. Dual Remission was defined as simultaneous asthma remission (Asthma Control Test (ACT) ≥ 20, no exacerbations, no oral corticosteroids (OCS) and stable lung function) and CRSwNP remission (Sino-Nasal Outcome Test-22 (SNOT-22) \< 40, Nasal Polyp Score (NPS) \> 1). We additionally analyzed "Complete Recovery" by applying a stricter composite definition requiring the restoration of normosmia (Sniffin' Sticks score \> 12). Results: At baseline, patients exhibited uncontrolled disease (median ACT 19, NPS 6). Treatment led to rapid asthma remission (85.7% at 12 months, 100% at 24 months). CRSwNP remission was slower but progressive, rising from 57% at 12 months to 88% at 24 months, demonstrating a significant "catch-up" phenomenon. Consequently, Dual Remission rates increased from 54% to 88% by month 24. When applying the stricter "Complete Recovery" criteria requiring normosmia, only 32% met the goal. Conclusion: Dupilumab is highly effective, enabling 88% of patients to achieve Dual Remission after 24 months. However, full olfactory restitution is distinct from structural polyp regression and harder to achieve, likely due to persistent neuroepithelial damage.

Status (registry)
Completed
Study type
Observational
Enrollment
205 (actual)
First submitted
28 Apr 2026
Start date
16 Jun 2025
Primary completion date
31 Mar 2026
Lead sponsor
Azienda Ulss 2 Marca Trevigiana
Diseases
Asthma
NCT number
NCT07574294

What you commit to

  • Study type: Observational
  • Participants enrolled: 205
  • From 16 Jun 2025 to the primary completion date, 31 Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Conditions that contraindicate dupilumab therapy (eosinophilic conditions, rheumatologic conditions, helminthic infection, restrictive or interstitial lung disease)

Other

  • Diagnosis of clinically significant bronchiectasis (overt diagnosis of bronchiectasis on chest CT)
  • Inability or lack of informed consent to participate in the study
  • Pregnancy
  • Breastfeeding

Who the study is looking for

  • All patients with comorbid severe asthma and CRSwNP who initiated treatment with dupilumab at Multidisciplinary Unit during the study period and met the pre-defined inclusion criteria ( diagnosis of severe asthma according to GINA guidelines and concomitant CRSwNP eligible for biological treatment)
  • Minimum age 18 years
  • Signature of informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Azienda ULSS 2 Marca Trevigiana
Coordinator of this site? Confirm its status
MontebellunaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.