Brief 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 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
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
* 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
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
Brief Title
Study Assessing Long-teRm Outcomes of dupiluMAb (DUPIXENT®) Treatment in Adult Patients With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Chronic Rhinosinusitis With Nasal Polyposis
Eligibility Criteria
Key Inclusion Criteria:
* 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
Key Exclusion Criteria:
* 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
* 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
Key Exclusion Criteria:
* 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
Inclusion Criteria
Inclusion Criteria:
* 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
* 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
Gender
All
Gender Based
false
Keywords
CRSwNP
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04959448
Org Class
Industry
Org Full Name
Regeneron Pharmaceuticals
Org Study Id
R668-cSNP-2072
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Assessing Long-Term Outcomes of DUPIXENT® Treatment in Patients With Chronic Rhinosinusitis With Nasal Polyposis (AROMA)
Primary Outcomes
Outcome Description
Demographics includes but is not limited to gender, age, ethnicity, height, weight, BMI, education, current employment status, physician information.
Outcome Measure
Baseline Patient Characteristics
Outcome Time Frame
Baseline up to 3 years
Outcome Description
Medical History includes but is not limited to history of CRSwNP, comorbid conditions, age at CRSwNP diagnosis, and baseline measurements of effectiveness variables.
Outcome Measure
Baseline Disease Characteristics
Outcome Time Frame
Baseline up to 3 years
Secondary Ids
Secondary Id
EUPAS41656
Secondary Outcomes
Outcome Description
Including but not limited to: usage, dosage, adherence, interruption, place (home or clinic) and frequency of administration
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
DUPIXENT® Treatment Characteristics
Outcome Description
Including but not limited to: usage, dosage, adherence, duration and frequency
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
CRSwNP Treatment Characteristics
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Incidence and severity of adverse events (AEs)
Outcome Description
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.
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Participant Assessment: Total symptom score (TSS), including sub-scores (nasal congestion [NC] and loss of smell [LOS])
Outcome Description
The UPSIT (UPSIT 40-odorant test) is a rapid and easy-to-administer method to quantitatively assess human olfactory function.
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Physician Assessment: Change in University of Pennsylvania Smell Identification Test (UPSIT) score
Outcome Description
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.
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.
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Physician Assessment: CT-Lund-Mackay Score
Outcome Description
Nasal peak inspiratory flow (NPIF) is a measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute.
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Physician Assessment: Nasal Peak Inspiratory Flow (PNIF)
Outcome Description
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
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Physician Assessment: - Forced Expiratory Volume in 1 second (FEV1)
Outcome Description
FeNO (Fractional exhaled Nitric Oxiide) is analyzed using a respiratory flow rate of 50 mL/second and reported in ppb.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)
Outcome Description
The ACQ-6 assesses asthma control with scores ranging from 0 (fully controlled; 6=severely uncontrolled).
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Participant Assessment: Asthma Control Questionnaire, 6-item (ACQ-6)
Outcome Description
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).
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Participant Assessment: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
Outcome Description
The AR-VAS assesses severity of rhinosinusitis symptoms on a 0 (not troublesome) to 10 (worst thinkable troublesome) scale.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Participant Assessment: Allergic Rhinitis (AR) using AR Visual Analog Scale (VAS)
Outcome Description
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).
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Participant Assessment: Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)
Outcome Description
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.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Participant Assessment: Sino-Nasal Outcome Test (SNOT-22)
Outcome Description
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.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Participant Assessment: Patient Oriented Eczema Measure (POEM)
Outcome Description
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.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Participant Assessment: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-CRSwNP)
Outcome Description
Resource use collected from medical, hospital, and pharmacy records
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Physician Assessment: Changes of Healthcare Utilization
Outcome Description
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.
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Participant Assessment: Short Form 12
Outcome Description
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).
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Participant Assessment: European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L)
Outcome Description
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.
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Participant Assessment: Global Impression for Symptom Severity, Treatment Satisfaction (Global Patient Assessment)
Outcome Description
The Global Physician Assessment is a 1-item question asking physicians to rate the severity of their patient's CRSwNP.
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Physician Assessment: Global Impression for Disease Severity (Global Physician Assessment)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Patients who are initiating treatment with DUPIXENT® for CRSwNP according to the country-specific prescribing information.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Golda Hudes
Investigator Email
ghudes@montefiore.org
Investigator Phone
646-229-9509