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Chronic Rhinosinusitis With Nasal PolyposisAROMANCT04959448

Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

An observational study of Chronic Rhinosinusitis With Nasal Polyposis, run by Regeneron Pharmaceuticals at 81 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary objectives of the study are: To longitudinally characterize the long-term effectiveness of DUPIXENT® through assessment of patient-reported symptoms, Health-Related Quality of Life (HRQoL) related to Chronic rhinosinusitis with nasal polyposis (CRSwNP) and other type 2 comorbidities, and their change… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DUPIXENT®
How many people
717 participants
Where
81 sitesin 6 countries
Study dates
12 Aug 2021to 25 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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: Patients who are initiating treatment with DUPIXENT® for CRSwNP according to the country-specific prescribing information.

Who may be able to join

  • All patients who are newly initiated on DUPIXENT® for the treatment of CRSwNP according to the respective prescribing information (Product Label or SmPC)
  • Willing and able to comply with clinic visits and study-related procedures as per protocol
  • Provide informed consent signed by study patient or legally acceptable representative
  • Able to understand and complete study-related questionnaires as per protocol

Who cannot join

  • Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
  • Any previous treatment with DUPIXENT® for any condition
  • Any condition that, in the opinion of the investigator, may interfere with the patient's ability to participate in the study per protocol
  • Participation in an ongoing interventional or observational study that might, in the treating physician's opinion, influence the assessments for the current study per protocol

Trial locations and contacts

81 sites in 6 countries.

81 sites in 6 countries

United States48 sites

  • University of Michigan, Michigan Medicine Pulmonary Clinic

    Ann Arbor, Michigan, 48109-5000

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • John Hopkins University School Of Medicine

    Baltimore, Maryland, 21224

  • Excel ENT of Alabama

    Birmingham, Alabama, 35244

  • Treasure Valley Medical Research

    Boise, Idaho, 83706

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Medical University Of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Health System (UVA)

    Charlottesville, Virginia, 22903

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Illinois

    Chicago, Illinois, 60612

  • The University of Chicago Medical Center UCMC Duchossois Center for Advanced Medicine DCAM

    Chicago, Illinois, 60637

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45229

  • University of Missouri

    Columbia, Missouri, 65212

  • IACT Health

    Columbus, Georgia, 31904

  • AADRS Clincial Research Center

    Coral Gables, Florida, 33134

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Asthma, Nasal Disease & Allergy Research Center of New England

    East Providence, Rhode Island, 02914

  • University of Florida

    Gainesville, Florida, 32610

  • Northwell Health

    Great Neck, New York, 11021

  • ADAC research, PA

    Greenville, South Carolina, 29607

  • Indiana University Health

    Indianapolis, Indiana, 46202

  • The Allergy and Rheumatology Medical Clinic

    La Jolla, California, 92037

  • Damask Physicians Group

    Lake Mary, Florida, 32746

  • Tanner Clinic

    Layton, Utah, 84041

  • Allergy and Asthma Physicians of RI

    Lincoln, Rhode Island, 02865

  • ARK Clinical Research

    Long Beach, California, 90806

  • Allergy & Asthma Center of Minnesota - Allergology

    Maplewood, Minnesota, 55109

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Montefiore Medical Center

    New York, New York, 10461

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23510

  • Asthma & Allergy Center of Chicago

    Oak Park, Illinois, 60301

  • Atlantic Research Center LLC

    Ocean City, New Jersey, 07712

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Allergy Partners of the Triangle

    Raleigh, North Carolina, 27607

  • Richmond Ear Nose & Throat

    Richmond, Virginia, 23235

  • Rochester Regional Health System

    Rochester, New York, 14626

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • STAAMP Research

    San Antonio, Texas, 78229

  • Scripps Health - Scripps Clinic Carmel Valley

    San Diego, California, 92130

  • Medical Research of Arizona, a division of Allergy, Asthma & Immunology Associates

    Scottsdale, Arizona, 85251

  • Spartanburg Ear, Nose & Throat Clinical

    Spartanburg, South Carolina, 29303

  • ENT & Allergy Partners

    Summerville, South Carolina, 29486

  • University of South Florida

    Tampa, Florida, 33612

  • Breathe Clear Institute

    Torrance, California, 90503

  • Essential Medical Research

    Tulsa, Oklahoma, 74137

  • The Vancouver Clinic

    Vancouver, Washington, 98664

  • Allergy & Asthma Clinical Research

    Walnut Creek, California, 94598

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

Italy10 sites

  • Azienda Ospedaliero Universitara Policlinico di Catania

    Catania, Sicily, 95125

  • Università Degli Studi Magna Graecia di Catanzaro

    Catanzaro, 88100

  • ENT Clinic San Martino Hospital

    Genova, 16126

  • AOU di Padova

    Padova, Veneto, 35128

  • Universita Degli Studi di Pisa Ospedale di Cisanello Pisa

    Pisa, Tuscany, 56100

  • Azienda Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"

    Rome, 00161

  • Fondazione universitaria Policlinico A. Gemelli

    Rome, 00168

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • Azienda Ospedaliero Universitaria di Sassari

    Sassari, 07100

  • Azienda Ospedaliero Universitaria Senese

    Siena, Tuscany, 53100

Other trials in Italy

Germany8 sites

  • Charité

    Berlin, Brandenburg, 10117

  • Praxis Dr. Yury Yarin

    Dresden, Saxony, 01139

  • Universitätsklinikum Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • Oberhavelkliniken Hennigsdorf

    Hennigsdorf, Brandenburg, 16761

  • Universitätsklinikum Jena

    Jena, Thuringia, 07740

  • University Hospital Mannheim - Dermatology, Venerology, Allergology

    Mannheim, Baden-Wurttemberg, 68167

  • University Hospital Münster

    Münster, North Rhine-Westphalia, 48149

  • Zentrum für Rhinologie

    Wiesbaden, Hesse, 65183

Other trials in Germany

Japan7 sites

  • Fujisawa City Hospital

    Fujisawa, Kanagawa, 251-8550

  • Osaka Haibikino Medical Center

    Habikino, Osaka, 583-8588

  • Kyoto Nose & Allergy Clinic

    Kyoto, 600-8216

  • Tokyo Kyosai Hospital

    Meguro-Ku, Tokyo, 153-8934

  • Nagaoka Red Cross Hospital - Otorhinolaryngology

    Nagaoka, Niigita, 940-2085

  • Matsuwaki Clinic Shinagawa

    Shinagawa-Ku, Tokyo, 141-0001

  • University of Fukui Hospital - Otorhinolaryngology

    Yoshida-gun, Hukui, 910-1193

Other trials in Japan

Canada5 sites

  • Centre hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 3E4

  • Hopital Du Saint-Sacrement

    Québec, G1S 4L8

  • Toronto Allergy & Asthma Clinic-Pulmonology

    Toronto, Ontario, M5G 1E2

  • ENT Clinic Sinus Center, St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Dr. Richard Gall Med Corp

    Winnipeg, Manitoba, R3P1C7

Other trials in Canada

Netherlands3 sites

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, North Holland, 1091 AC

  • Amsterdam UMC location AMC

    Amsterdam, North Holland, 1105

  • Alrijne Ziekenhuis

    Leiderdorp, South Holland, 2353

Other trials in Netherlands

About this study

Official title: Assessing Long-Term Outcomes of DUPIXENT® Treatment in Patients With Chronic Rhinosinusitis With Nasal Polyposis (AROMA)

The primary objectives of the study are:

  • To longitudinally characterize the long-term effectiveness of DUPIXENT® through assessment of patient-reported symptoms, Health-Related Quality of Life (HRQoL) related to Chronic rhinosinusitis with nasal polyposis (CRSwNP) and other type 2 comorbidities, and their change over-time.
  • To characterize patients who receive DUPIXENT® for CRSwNP in a real-world setting with respect to their medical history, demographic and disease characteristics, and type 2 comorbidities
Read more

The secondary objectives of the study are:

  • To characterize real-world utilization of DUPIXENT® for patients with CRSwNP
  • To collect patient and physician global assessment of disease severity and treatment satisfaction for patients receiving DUPIXENT® for CRSwNP
  • To collect long-term safety data for patients receiving DUPIXENT® for CRSwNP
Being tested
DUPIXENT®
Keywords
CRSwNP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DUPIXENT®Drug

    Also called dupilumab, REGN668, SAR231893

    No investigational agents will be provided. All treatments will be prescribed at the discretion of the study physician and other healthcare providers.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline Patient Characteristics

    Demographics includes but is not limited to gender, age, ethnicity, height, weight, BMI, education, current employment status, physician information.

    Measured: Baseline up to 3 years

  2. Baseline Disease Characteristics

    Medical History includes but is not limited to history of CRSwNP, comorbid conditions, age at CRSwNP diagnosis, and baseline measurements of effectiveness variables.

    Measured: Baseline up to 3 years

Secondary outcomes (21)

  1. DUPIXENT® Treatment Characteristics

    Including but not limited to: usage, dosage, adherence, interruption, place (home or clinic) and frequency of administration

    Measured: Baseline up to 3 years

  2. CRSwNP Treatment Characteristics

    Including but not limited to: usage, dosage, adherence, duration and frequency

    Measured: Baseline up to 3 years

  3. Incidence and severity of adverse events (AEs)

    Measured: Baseline up to 3 years

  4. Participant Assessment: Total symptom score (TSS), including sub-scores (nasal congestion [NC] and loss of smell [LOS])

    The TSS is a composite score (ranging between 0 and 9) and consisting of the sum of the following symptoms assessed daily: nasal congestion/obstruction, decreased/loss of sense of smell, rhinorrhea (average of anterior/posterior nasal discharge). Higher scores indicate greater symptom burden.

    Measured: Baseline up to 3 years

  5. Physician Assessment: Change in University of Pennsylvania Smell Identification Test (UPSIT) score

    The UPSIT (UPSIT 40-odorant test) is a rapid and easy-to-administer method to quantitatively assess human olfactory function.

    Measured: Baseline up to 3 years

  6. Physician Assessment: CT-Lund-Mackay Score

    The LMK system is scoring based on CT imaging of the sinuses with points given for degree of opacification:

    0 = no opacification, 1 = partial opacification, 2 = total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side. The ostiomeatal complex is graded as 0 = not occluded, or 2 = occluded. The sum of these derives a maximum score of 12 per side and 24 in total.

    Measured: Baseline up to 3 years

  7. Physician Assessment: Nasal Peak Inspiratory Flow (PNIF)

    Nasal peak inspiratory flow (NPIF) is a measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute.

    Measured: Baseline up to 3 years

  8. Physician Assessment: - Forced Expiratory Volume in 1 second (FEV1)

    Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled in the first second of a forced exhalation

    Measured: Baseline up to 3 years

  9. Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)

    FeNO (Fractional exhaled Nitric Oxiide) is analyzed using a respiratory flow rate of 50 mL/second and reported in ppb.

    Measured: Baseline up to 3 Years

  10. Participant Assessment: Asthma Control Questionnaire, 6-item (ACQ-6)

    The ACQ-6 assesses asthma control with scores ranging from 0 (fully controlled; 6=severely uncontrolled).

    Measured: Baseline up to 3 Years

  11. Participant Assessment: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)

    The MiniAQLQ is assesses the impact of asthma on health-related quality of life with scores ranging from 1 (maximum impairment) to 7 (no impairment).

    Measured: Baseline up to 3 Years

  12. Participant Assessment: Allergic Rhinitis (AR) using AR Visual Analog Scale (VAS)

    The AR-VAS assesses severity of rhinosinusitis symptoms on a 0 (not troublesome) to 10 (worst thinkable troublesome) scale.

    Measured: Baseline up to 3 Years

  13. Participant Assessment: Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)

    The MiniRQLQ is an abbreviated version of the RQLQ(S)+12 which assesses health-related quality of life associated with perennial or seasonal allergic rhinitis with scores ranging from 0 (not troubled) to 6 (extremely troubled).

    Measured: Baseline up to 3 Years

  14. Participant Assessment: Sino-Nasal Outcome Test (SNOT-22)

    The SNOT-22 assesses the impact of chronic rhinosinusitis on health-related quality of life with scores ranging from 0 to 110; lower scores representing better health related quality of life.

    Measured: Baseline up to 3 Years

  15. Participant Assessment: Patient Oriented Eczema Measure (POEM)

    The POEM assesses symptoms of dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping with scores ranging from 0 to 28; higher scores indicate greater symptom burden.

    Measured: Baseline up to 3 Years

  16. Participant Assessment: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-CRSwNP)

    The WPAI-CRSwNP measures impairments in work and activities associated with CRSwNP. Scores are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

    Measured: Baseline up to 3 Years

  17. Physician Assessment: Changes of Healthcare Utilization

    Resource use collected from medical, hospital, and pharmacy records

    Measured: Baseline up to 3 years

  18. Participant Assessment: Short Form 12

    The SF-12 assesses physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/vitality, pain, and general health perception with scores ranging from 0 to 100; lower scores represent greater quality of life impairment.

    Measured: Baseline up to 3 years

  19. Participant Assessment: European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L)

    The EQ 5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and the EQ-VAS records the respondent's self rated health on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).

    Measured: Baseline up to 3 years

  20. Participant Assessment: Global Impression for Symptom Severity, Treatment Satisfaction (Global Patient Assessment)

    The Global Patient Assessment is a 2-component questionnaire on symptom severity over the past week and the patient's overall satisfaction with their CRSwNP treatment.

    Measured: Baseline up to 3 years

  21. Physician Assessment: Global Impression for Disease Severity (Global Physician Assessment)

    The Global Physician Assessment is a 1-item question asking physicians to rate the severity of their patient's CRSwNP.

    Measured: Baseline up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2021
  2. Study start12 Aug 2021
  3. Primary completion25 Mar 2027 (estimated)
  4. Study completion25 Mar 2027 (estimated)

Resources

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
Prospective
Enrolment
717 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04959448
Sponsor's protocol ID
R668-cSNP-2072
Other IDs
42822
Acronym
AROMA
Status last verified
Jul 2026
First submitted
21 Jun 2021
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Publications

  • Peters AT, White AA, Fujieda S, Heffler E, Buchheit KM, Cornet ME, Xia C, Nash S, Corbett M, Almansa C, Radwan A, Wagenmann M. Dupilumab effectiveness and safety in patients with chronic rhinosinusitis with nasal polyps: Two-year results from the Assessing long-teRm Outcomes in dupiluMAb registry. Ann Allergy Asthma Immunol. 2026 Jul 27:S1081-1206(26)00359-5. doi: 10.1016/j.anai.2026.07.022. Online ahead of print.

    PubMed 42508565

  • Peters AT, Shah R, Heffler E, Wagenmann M, Fujieda S, Xia C, Nash S, Clotz M, Corbett M, Radwan A. Baseline disease characteristics among patients with chronic rhinosinusitis with nasal polyps in AROMA: A global registry study. Allergy Asthma Proc. 2025 Sep 1;46(5):414-421. doi: 10.2500/aap.2025.46.250055.

    PubMed 40958188

  • Siddiqui S, Bachert C, Chaker AM, Han JK, Hellings PW, Peters AT, Heffler E, Kamat S, Zhang H, Nash S, Khan AH, De Prado Gomez L, Jacob-Nara JA, Rowe PJ, Deniz Y. AROMA: real-world global registry of dupilumab for chronic rhinosinusitis with nasal polyps. ERJ Open Res. 2022 Nov 28;8(4):00085-2022. doi: 10.1183/23120541.00085-2022. eCollection 2022 Oct.

    PubMed 36451848

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Rhinosinusitis With Nasal Polyposis, run by Regeneron Pharmaceuticals at 81 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Italy, Germany, Japan, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline Patient Characteristics (time frame: Baseline up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04959448, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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