AsthmaDREAM-NPNCT07574294
Dual REmission in Moderate-to-SEvere asthMa and Nasal Polyps
An observational study of Asthma and Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Azienda Ulss 2 Marca Trevigiana at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- What is being tested?
- Not applicable- observational study and Dupilumab
- How many people
- 205 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2025to 31 Mar 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual Remission in Patients With Moderate-to-Severe Asthma and CRSwNP Treated With Dupilumab: A 24-Month Real-World Study
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.
Read the detailed description
- Background and Rationale Asthma is a heterogeneous chronic inflammatory airway disease affecting approximately 300 million people worldwide. Roughly 5-10% of patients suffer from severe asthma, leading to significant clinical impact and high resource consumption. Patients with severe asthma often present with comorbidities driven by T2-high (Type 2-high) inflammation, characterized by persistent blood hypereosinophilia and increased tissue expression of IL-5 (Interleukin-5). The most frequent comorbidity is CRSwNP (Chronic Rhinosinusitis with Nasal Polyps). This is often explained by the "unified airway theory," suggesting that the upper and lower airways function as a single unit subjected to similar inflammatory insults. While biologic therapies like dupilumab, which targets IL-4/13R (Interleukin-4/13 Receptor), have revolutionized treatment, the goal has shifted toward achieving clinical remission. According to the SANI (Severe Asthma Network Italy), clinical remission in asthma is defined by:
- No further need for OCS (Oral Corticosteroids).
- Absence of exacerbations.
- Stable lung function.
- Absence of symptoms, measured by an ACT (Asthma Control Test) score of 20-25 or an ACQ (Asthma Control Questionnaire) score < 1.5.
- For CRSwNP (Chronic Rhinosinusitis with Nasal Polyps), EUFOREA (European Forum for Research and Education in Allergy and Airway Diseases) defines remission as a condition with an NPS (Nasal Polyp Score) < 4, NCS (Nasal Congestion Severity) < 2, and no need for surgery or systemic corticosteroids after 12 months.
- Study Objectives Primary Objective: To evaluate the clinical efficacy of dupilumab after 12 months of treatment in patients with comorbid asthma and CRSwNP (Chronic Rhinosinusitis with Nasal Polyps) regarding:
- Percentage of patients in complete clinical remission for asthma according to SANI (Severe Asthma Network Italy) criteria.
- Percentage of patients in complete clinical remission for CRSwNP (Chronic Rhinosinusitis with Nasal Polyps) according to EPOS (European Position Paper on Rhinosinusitis and Nasal Polyps)/EUFOREA (European Forum for Research and Education in Allergy and Airway Diseases) criteria.
- Percentage of patients achieving simultaneous complete clinical remission for both conditions. Secondary Objectives (at 1, 6, and 12 months):
- Partial clinical remission rates.
- Improvement in disease control scores, specifically ACT (Asthma Control Test) and SNOT-22 (22-Item Sino-Nasal Outcome Test).
- Stabilization of spirometric parameters.
- Reduction in OCS (Oral Corticosteroids) use and annual asthma exacerbation rates.
- Improvement in smell via identification tests.
- Study Design and Population This is a no-profit, observational, retrospective, multicenter study. Setting: Adult patients (≥18 years) followed for at least 12 months since starting dupilumab. Sample Size: Approximately 280 patients across 14 centers. Inclusion Criteria: Diagnosis of CRSwNP (Chronic Rhinosinusitis with Nasal Polyps) per EPOS (European Position Paper on Rhinosinusitis and Nasal Polyps) 2020 and asthma per ERS (European Respiratory Society)/ATS (American Thoracic Society) 2014. Exclusion Criteria: Conditions contraindicating dupilumab, clinically significant bronchiectasis confirmed by CT (Computed Tomography), or pregnancy/breastfeeding.
- Data Management and Statistical Plan Data collection includes four timepoints: baseline, 1 month, 6 months, and 12 months. Key Variables: Blood Biomarkers: Blood eosinophils and total IgE (Immunoglobulin E). Functional Tests: FeNO (Fractional exhaled Nitric Oxide) and plethysmography parameters such as FEV1 (Forced Expiratory Volume in 1 second), FVC (Forced Vital Capacity), TLC (Total Lung Capacity), and DLCO (Diffusing Capacity for Carbon Monoxide). Statistical Analysis: Descriptive statistics will be used for all baseline and follow-up characteristics. Normality will be assessed via the Shapiro test. A Bayesian method will be applied to manage missing data and cluster the population to control for confounding factors.
- Ethical Considerations The study will be conducted in accordance with the Declaration of Helsinki. Participation is subject to obtaining free and informed consent, safeguarding data protection rights under GDPR (General Data Protection Regulation) EU (European Union) 679/2016. Researchers report no potential conflicts of interest.
- Being tested
- Not applicable- observational study, Dupilumab
- Keywords
- asthma, chronic rhinosinusitis with nasal polyps, dupilumab, dual remission, real-world evidence, type 2 inflammation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 205 patients with comorbid moderate-to-severe asthma and CRSwNP. | Not described Receives: Other: Not applicable- observational study; Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start16 Jun 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ulss 2 Marca Trevigiana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Menzella, Azienda Ulss 2 Marca Trevigiana
- Investigators
- Francesco Menzella, Medicine and Surgery, Principal investigator, Azienda Ulss 2 Marca Trevigiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574294
- Sponsor's protocol ID
- 2025-43 PROT N. 0015184/25
- Acronym
- DREAM-NP
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38217529Canonica 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.
PubMed 37558162De 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.
PubMed 37203259De 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.
PubMed 40884177Menzella 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.
PubMed 41977087Menzella F, De Corso E, Caminati M, Cestaro W, Ventura L, Cameli P, Munari S, Semenzato U, Chan R, Berti A, Ghidini A, Russo P, Ruzzon I, De Massimi A, Marchi MR, Lombardi C, Bortoli M, Rinaldo C, Pozzan R, Vassallo FG, Gialdini F, Scandiuzzi Piovesan T, Cottini M, Senna G, Corsi L, Romano A, Tozzi A, Ottaviano G; DREAM-NP Study Group. Dual REmission in moderate-to-severe AsthMa and Nasal Polyps: a multicentric observational Phase IV real-life study (DREAM-NP). Expert Opin Biol Ther. 2026 Jul 26:1-10. doi: 10.1080/14712598.2026.2710254. Online ahead of print.
PubMed 42496183