Brief Summary
The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life.
This includes characterization of:
* Patient demographics (eg, gender, age, and race)
* Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height)
The secondary objectives of the study are:
* To characterize real-world use patterns of DUPIXENT® for asthma
* To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting
* To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT®
* To collect long-term safety data on study participants in the real-world setting
This includes characterization of:
* Patient demographics (eg, gender, age, and race)
* Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height)
The secondary objectives of the study are:
* To characterize real-world use patterns of DUPIXENT® for asthma
* To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting
* To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT®
* To collect long-term safety data on study participants in the real-world setting
Brief Title
Registry of Asthma Patients Initiating DUPIXENT®
Detailed Description
3-year registry of real-world use of DUPIXENT® for asthma in patients age 12 and over
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Asthma
Eligibility Criteria
Key Inclusion Criteria:
* Willing and able to comply with the required clinic visits, study procedures and assessments
* Able to understand and complete study-related questionnaires
* Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required
* Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information
Key Exclusion Criteria:
* Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
* Treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day
* Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
* Willing and able to comply with the required clinic visits, study procedures and assessments
* Able to understand and complete study-related questionnaires
* Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required
* Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information
Key Exclusion Criteria:
* Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
* Treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day
* Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Inclusion Criteria
Inclusion Criteria:
* Willing and able to comply with the required clinic visits, study procedures and assessments
* Able to understand and complete study-related questionnaires
* Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required
* Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information
Inclusion/
* Willing and able to comply with the required clinic visits, study procedures and assessments
* Able to understand and complete study-related questionnaires
* Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required
* Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information
Inclusion/
Gender
All
Gender Based
false
Keywords
Primary Indication of Asthma
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
12 Years
NCT Id
NCT04287621
Org Class
Industry
Org Full Name
Regeneron Pharmaceuticals
Org Study Id
R668-AS-1885
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Registry of Asthma Patients Initiating DUPIXENT® (RAPID)
Primary Outcomes
Outcome Description
Including gender, age, race
Outcome Measure
Demography
Outcome Time Frame
At Baseline
Outcome Description
Including prior medications and procedures, medical history, asthma history, weight, height
Outcome Measure
Baseline Characteristics
Outcome Time Frame
At Baseline
Secondary Ids
Secondary Id
EUPAS41963
Secondary Outcomes
Outcome Description
Including but not limited to treatment dose, frequency, duration and asthma treatment associations.
Outcome Time Frame
At Baseline
Outcome Measure
Baseline Treatment Characteristics
Outcome Description
Including but not limited to: frequency, percentage and exposure-adjusted incidence rate of AEs
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Incidence of adverse events (AEs)
Outcome Description
Assessment collected as per standard of care. Includes forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory flow (FEF) between 25% to 75% of vital capacity (FEF25%-75%), post-bronchodilator FEV1.
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Physician Assessment: - Spirometry
Outcome Description
Assessment collected as per standard of care.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)
Outcome Description
Questionnaire assessing the most common asthma symptoms during the previous week, using a 7-point Likert scale (0=fully controlled; 6=severely uncontrolled). Higher score indicates worse asthma control.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Patient Reported Outcome: Asthma Control Questionnaire, 6-item (ACQ-6)
Outcome Description
Questionnaire answered using a 7-point Likert scale (1=maximum impairment; 7=no impairment). Higher score indicates less impact of asthma on quality of life.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Patient Reported Outcome: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
Outcome Description
Assessing patient's symptom severity over the past week and the patient's overall satisfaction with their asthma treatment. Higher scores indicate higher severity of asthma symptoms and lower satisfaction with asthma treatment.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Patient Reported Outcome: Global Patient Assessment
Outcome Description
Assessing patient's physical activity in their free time. Higher score indicates more health-related quality of life impairment.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Patient Reported Outcome: Physical Activity Limitation Questionnaire (PALQ)
Outcome Description
Assessing severity of rhinits symptoms where higher score indicates more bothersome allergic symptoms.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Patient Reported Outcome in patients with allergic rhinitis: Allergic Rhinitis Visual Analog Scale (AR-VAS)
Outcome Description
Health-related quality of life signs and symptoms that are most problematic, as a result of perennial or seasonal allergic rhinitis. RQLQ(S)+12 responses are based on 7-point Likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). Higher score indicates more health-related quality of life impairment.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Patient Reported Outcome in patients with allergic rhinitis: Standardized Rhinoconjunctivitis Quality of Life Questionnaire for patients 12 years of age and older (RQLQ[S]+12)
Outcome Description
Questionnaire to assess the impact of chronic rhinosinusitis on quality of life. Lower score represents better health related quality of life.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Patient Reported Outcome in patients with chronic (rhino) sinusitis and/or nasal polyps: Sino-Nasal Outcome Test (SNOT-22)
Outcome Description
Questionnaire assessing eczema severity with lower score representing impact of lower severity of less severe eczema.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Patient Reported Outcome in patients with atopic dermatitis: Patient Oriented Eczema Measure (POEM)
Outcome Description
Questionnaire to measure impairments in work and activities with higher score indicating greater impairment and less productivity.
Outcome Time Frame
Baseline up to 3 Years
Outcome Measure
Patient Reported Outcome: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-asthma)
Outcome Description
The HCRUQ collects information on unscheduled healthcare resource encounters related to asthma
Outcome Time Frame
Baseline up to 3 years
Outcome Measure
Healthcare Utilization: Healthcare Resource Utilization Questionnaire (HCRUQ)
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
The target population comprises adult and adolescent patients (male or female, ≥12 years old), who are initiating treatment with DUPIXENT® for asthma according to the country-specific prescribing information.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Golda Hudes
Investigator Email
ghudes@montefiore.org
Investigator Phone
646-229-9509
Investigator Department
Medicine
Investigator Division
Allergy & Immunology
Investigator Sponsor Organization
External
Study Department
Medicine
Study Division
Allergy & Immunology
Categories Mesh Debug
Asthma and Other Respiratory Diseases --- BRONCHIAL DISEASES
Lung --- BRONCHIAL DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Lung --- LUNG DISEASES, OBSTRUCTIVE
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY HYPERSENSITIVITY
Lung --- RESPIRATORY HYPERSENSITIVITY
Lung --- HYPERSENSITIVITY, IMMEDIATE
Lung --- HYPERSENSITIVITY
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
ASTHMA
BRONCHIAL DISEASES
RESPIRATORY TRACT DISEASES
LUNG DISEASES, OBSTRUCTIVE
LUNG DISEASES
RESPIRATORY HYPERSENSITIVITY
HYPERSENSITIVITY, IMMEDIATE
HYPERSENSITIVITY
IMMUNE SYSTEM DISEASES
DUPILUMAB