CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 205 enrolled
Drug / intervention
Dupilumab +1 moredrug
Likely dose
Dupilumab 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07574294
NCT07574294N/ACompleted

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

Azienda Ulss 2 Marca Trevigiana·observational·Posted May 7, 2026·Updated May 7, 2026

In Brief

An observational study evaluating Not applicable- observational study and Dupilumab for Asthma and Chronic Rhinosinusitis With Nasal Polyps (CRSwNP). Completed, enrolled 205 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2026
First PostedMay 7, 2026
Enrollment StartJun 16, 2025
Primary CompletionMar 31, 2026
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 2 months ago

Interventions

Not applicable- observational studyother

observational study

Dupilumabdrug

Retrospective multicentric observational study was performed on a cohort of 205 consecutive adult outpatients with comorbid asthma and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). The study involved a total of 13 clinical centers across Italy, coordinated by the Multidisciplinary Pulmonology and Otolaryngology Unit of the S. Valentino Hospital in Montebelluna, Italy. All participating satellite centers followed a follow-up schedule similar to that of the coordinating center to ensure data consistency. All patients received dupilumab 300 mg every 15 days. A 600 mg loading dose was administered exclusively to the severe asthma group, following the approved summary of product characteristics. Clinical Endpoints and Definitions Data were collected at baseline (T0), 6 months (T6), 12 months (T12), and 24 months (T24).