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

NCT07574294 | Completed FDA Drug

• 1 other identifier: 2025-43 PROT N. 0015184/25
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Keywords

asthma; chronic rhinosinusitis with nasal polyps; dupilumab; dual remission; real-world evidence; type 2 inflammation

Outcome Measures

Primary Outcomes (1)

• Achievement of Dual Remission

  Achievement of Dual Remission: Asthma Remission was defined according to the Severe Asthma Network Italy (SANI) criteria as the simultaneous presence of: (1) no OCS use, (2) no exacerbations, (3) ACT score ≥ 20, and (4) stable pulmonary function (FEV1); CRSwNP Remission was defined according to EPOS/EUFOREA guidelines as: (1) an NPS ≤ 1 and (2) a SNOT-22 score \< 40.

  24 months

Study Arms (1)

205 patients with comorbid moderate-to-severe asthma and CRSwNP.

Other: Not applicable- observational study; Drug: Dupilumab

Interventions

Not applicable- observational study OTHER

observational study

205 patients with comorbid moderate-to-severe asthma and CRSwNP.

Dupilumab DRUG

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).

205 patients with comorbid moderate-to-severe asthma and CRSwNP.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with comorbid severe asthma and CRSwNP who initiated treatment with dupilumab at our Multidisciplinary Unit during the study period and met the pre-defined inclusion criteria were included in the analysis. No patients were excluded based on treatment response or clinical outcomes. All subjects were treated with dupilumab (initial dose of 600 mg followed by 300 mg every 2 weeks) as an add-on therapy. Inclusion criteria were a diagnosis of severe asthma according to GINA guidelines and concomitant CRSwNP eligible for biological treatment.

You may qualify if:

• Minimum age 18 years
• Signature of informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ulss 2 Marca Trevigiana: lead

Study Sites (1)

Azienda ULSS 2 Marca Trevigiana

Montebelluna, Treviso, 31044, Italy

Location

Related Publications (5)

• Fokkens WJ, De Corso E, Backer V, Bernal-Sprekelsen M, Bjermer L, von Buchwald C, Chaker A, Diamant Z, Gevaert P, Han J, Hopkins C, Hox V, Klimek L, Lund VJ, Lee S, Luong A, Mullol J, Peters A, Pfaar O, Reitsma S, Toppila-Salmi S, Scadding GK, Sedaghat AR, Viskens AS, Wagenmann M, Hellings PW. EPOS2020/EUFOREA expert opinion on defining disease states and therapeutic goals in CRSwNP. Rhinology. 2024 Jun 1;62(3):287-298. doi: 10.4193/Rhin23.415.

  PMID: 38217529 BACKGROUND

• Canonica GW, Blasi F, Carpagnano GE, Guida G, Heffler E, Paggiaro P, Allegrini C, Antonelli A, Aruanno A, Bacci E, Bagnasco D, Beghe B, Bonavia M, Bonini M, Brussino L, Caiaffa MF, Calabrese C, Camiciottoli G, Caminati M, Caruso C, Cavallini M, Chieco Bianchi F, Conte ME, Corsico AG, Cosmi L, Costantino M, Costanzo G, Crivellaro M, D'Alo S, D'Amato M, Detoraki A, Di Proietto MC, Facciolongo NC, Ferri S, Fierro V, Foschino MP, Latorre M, Lombardi C, Macchia L, Milanese M, Montagni M, Parazzini EM, Parente R, Passalacqua G, Patella V, Pelaia G, Pini L, Puggioni F, Ricciardi L, Ridolo E, Rolo J, Scichilone N, Scioscia G, Senna G, Solidoro P, Varricchi G, Vianello A, Yacoub MR, Yang B. Severe Asthma Network Italy Definition of Clinical Remission in Severe Asthma: A Delphi Consensus. J Allergy Clin Immunol Pract. 2023 Dec;11(12):3629-3637. doi: 10.1016/j.jaip.2023.07.041. Epub 2023 Aug 7.

  PMID: 37558162 BACKGROUND

• De Corso E, Pasquini E, Trimarchi M, La Mantia I, Pagella F, Ottaviano G, Garzaro M, Pipolo C, Torretta S, Seccia V, Cantone E, Ciofalo A, Lucidi D, Fadda GL, Pafundi PC, Settimi S, Montuori C, Anastasi F, Pagliuca G, Ghidini A, Cavaliere C, Maffei M, Bussu F, Gallo S, Canevari FRM, Paludetti G, Galli J; Dupireal Italian Study Group. Dupilumab in the treatment of severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP): A multicentric observational Phase IV real-life study (DUPIREAL). Allergy. 2023 Oct;78(10):2669-2683. doi: 10.1111/all.15772. Epub 2023 May 26.

  PMID: 37203259 BACKGROUND

• De Corso E, Montuori C, Pipolo C, La Mantia I, Pasquini E, Ghidini A, Seccia V, Ottaviano G, Cantone E, Dane G, Garzaro M, Fadda GL, Torretta S, Anastasi F, Canevari FRM, Pagella F, Lucidi D, Cavaliere C, Pagliuca G, Maffei M, Bussu F, Corbo M, D Auria LM, De Maio G, Loperfido A, Gallo S, D Agostino G, Giannarelli D, Galli J; DUPIREAL Italian Study Group. Two-Year Turning Point With Dupilumab in Chronic Rhinosinusitis with Nasal Polyps: Control, Remission, and Tapering Dosage. Allergy. 2026 Feb;81(2):388-401. doi: 10.1111/all.70032. Epub 2025 Aug 30.

  PMID: 40884177 BACKGROUND

• Menzella F, Berti A, Cestaro W, Bosi A, Munari S, Gialdini F, Scandiuzzi Piovesan T, Cottini M, Lombardi C, Corsi L, De Corso E. Dual Remission in Patients with Moderate-to-Severe Asthma and CRSwNP Treated with Dupilumab: A 24-Month Real-World Study. J Clin Med. 2026 Apr 7;15(7):2787. doi: 10.3390/jcm15072787.

  PMID: 41977087 BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Francesco Menzella, Medicine and Surgery

  Azienda Ulss 2 Marca Trevigiana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 7, 2026
• Study Start: June 16, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)