Registry of Asthma Patients Initiating DUPIXENT® (RAPID)

Registry of Asthma Patients Initiating DUPIXENT® (RAPID)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: DUPIXENT®

Detailed Description

3-year registry of real-world use of DUPIXENT® for asthma in patients age 12 and over

• Study Type: Observational
• Enrollment (Actual): 718

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• Canada
  • Québec, Canada, G1V 4G5
    • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) - Universite Laval
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • The University of British Columbia
  • Ontario
    • Burlington, Ontario, Canada, L7N 3V2
      • BLC Clinical Research
    • Toronto, Ontario, Canada, M5T 3A9
      • Inspiration Research Limited
    • Toronto, Ontario, Canada, M5G 1E2
      • Evidence Based Medical Educator Inc.
    • Windsor, Ontario, Canada, N8X 1T3
      • Dr. Syeed Anees Medicine Professional Corporation
• Denmark
  • Vejle, Denmark, 7100
    • Sygehus Lillebaelt - Vejle Sygehus - Lungemedicinsk afdeling
• France
  • Aix-en-Provence, France, 13100
    • Centre Hospitalier du Pays d'Aix - Maladies Respiratoires
  • Bordeaux, France, 33076
    • CHU de Bordeaux
  • Dijon, France, 21079
    • Centre Hospitalier Universitaire Dijon Bourgogne (CHU Dijon) - Hôpital Francois Mitterrand
  • Lyon, France, 69317
    • Hôpital de la Croix-Rousse
  • Marseille, France, 13015
    • Hôpital Nord
  • Montivilliers, France, 76290
    • Hopital Jacques Monod
• Italy
  • Lombardia
    • Milano, Lombardia, Italy, 20154
      • Ospedale dei Bambini Vittore Buzzi ASST Fatebenefratelli Sacco
    • Milano, Lombardia, Italy, 20157
      • Ospedale Luigi Sacco, PU, ASST Fatebenefratelli Sacco
    • Pavia, Lombardia, Italy, 27100
      • La Fondazione IRCCS Policlinico "San Matteo"
    • Rozzano, Lombardia, Italy, 20089
      • Istituto Clinico Himanitas, Humanitas Mirasole S.p.a.
  • Marche
    • Ancona, Marche, Italy, 60127
      • Istituto Nazionale di Riposo e Cura per Anziani
  • Puglia
    • Bari, Puglia, Italy, 70020
      • Fondazione Salvatore Maugeri
  • Salerno
    • Battipaglia, Salerno, Italy, 84091
      • Azienda Sanitaria Locale Salerno
• Japan
  • Aichi
    • Kiyosu-shi, Aichi, Japan, 452-0001
      • Hansaki Clinic
  • Hokkaido
    • Kita-ku, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0017
      • Kobe University Hospital
  • Tochigi
    • Mibu, Tochigi, Japan, 321-0293
      • Dokkyo Medical University Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-0033
      • Juntendo University Hospital
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Incorporated Medical Corporation, Shishin Iryokai, Respiratory Care Clinic Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Nihon University Itabashi Hospital
    • Itabashi-ku, Tokyo, Japan, 173-8606
      • Teikyo University Hospital
    • Nakano ku, Tokyo, Japan, 164-0012
      • Incorporated Medical Corporation, Jinyukai, Jinyu Clinic
    • Shinagawa-ku, Tokyo, Japan, 142-8666
      • Showa University Hospital
    • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Tokyo Women's Medical University Hospital
    • Sumida-ku, Tokyo, Japan, 130-8587
      • The Fraternity Memorial Hospital
• Puerto Rico
  • Cayey, Puerto Rico, 00736
    • Agosto Allergy and Immunology
  • Guaynabo, Puerto Rico, 00968
    • CardioPulmonary Research CSP
  • Ponce, Puerto Rico, 00731
    • Instituto Pulmonary Diseases Torre Medica San Lucas
  • San Juan, Puerto Rico, 00927
    • Fundacion De Investigacion de Diego
  • San Juan, Puerto Rico, 00936
    • University of Puerto Rico Medical Sciences Campus
  • San Juan, Puerto Rico, 00918
    • Rafael H Zaragoza - Urdaz
• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08025
      • Hospital De La Santa Creu I Sant Pau
    • Barcelona, Catalonia, Spain, 08035
      • Hospital Universitari Vall d'Hebron
    • Barcelona, Catalonia, Spain, 08916
      • Hospital Germans Trias i Pujol
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Complexo Hospialario Universitario A Coruña
• Sweden
  • Stockholms Län [se-01]
    • Lidingö, Stockholms Län [se-01], Sweden, SE-181 58
      • Fysikalisk Medicin
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • University Hospitals Birmingham NHS Foundation Trust
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon University Healthcare NHS Foundation Trust
  • Glasgow, United Kingdom, G12 0YN
    • Gartnavel General Hospital
  • Leeds, United Kingdom, LS9 7TF
    • St. James Hospital Leeds
  • Leicester, United Kingdom, LE3 9QP
    • Glenfield General Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • London, United Kingdom, EC1A 7BE
    • St. Bartholomew's Hospital
  • Manchester, United Kingdom, M23 9QZ
    • Wythenshawe Hospital
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital
  • Nottingham, United Kingdom, NG5 1PD
    • Nottingham University Hospitals NHS Trust
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M8 5RB
      • Pennine Acute Hospitals NHS Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Clinical Research Center of Alabama, LLC
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Arizona Allergy & Immunology Research
    • Scottsdale, Arizona, United States, 85251
      • Medical Research of Arizona, a Division of Allergy, Asthma & Immunology Associates, Ltd.
  • California
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County
    • Redondo Beach, California, United States, 90277
      • Riviera Allergy Medical Center
    • San Diego, California, United States, 92123
      • Allergy & Asthma Medical Group and Research, A PC
    • Stockton, California, United States, 95207
      • Bensch Clinical Research, LLC
    • Westminster, California, United States, 92683
      • Allianz Research Institute, Inc.
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial healthcare System
    • Hollywood, Florida, United States, 33021
      • Global Research Solutions
    • Kissimmee, Florida, United States, 34746
      • Clinical Research Specialists, LLC
    • Port Richey, Florida, United States, 34653
      • Kratz Allergy & Asthma
    • Saint Petersburg, Florida, United States, 33702
      • GCP, Global Clinical Professionals
    • Tallahassee, Florida, United States, 32308
      • Allergy & Asthma Diagnostic Treatment Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Omni Allergy
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Rincon, Georgia, United States, 31326
      • IACT Health Southeast Lung Associates
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Group Allergy & Immunology Clinic
    • Chicago, Illinois, United States, 60634
      • The University of Chicago
    • Evanston, Illinois, United States, 60201
      • Northshore University Health System
    • Oak Park, Illinois, United States, 60301
      • Asthma and Allergy Center of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children at Indiana University Health
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Velocity Clinical Research
    • Overland Park, Kansas, United States, 66211
      • Dr. Henry J. Kanarek Allergy, Asthma & Immunology
  • Kentucky
    • Louisville, Kentucky, United States, 40291
      • Family Allergy and Asthma
    • Owensboro, Kentucky, United States, 42301
      • Allergy & Asthma Specialists, PSC
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Schreiber Allergy
    • Silver Spring, Maryland, United States, 20910
      • Virgo-Carter Pediatrics
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research, Inc.
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Ann Arbor, Michigan, United States, 48106
      • University of Michigan Allergy Specialty Clinic and Food Allergy Clinic
  • Minnesota
    • Maplewood, Minnesota, United States, 55109
      • Allergy and Asthma Center of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65201
      • ENT & Allergy Center of Missouri
    • Saint Louis, Missouri, United States, 63141
      • The Clinical Research Center, LLC
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • Nebraska Medical Research Institute, Inc.
    • Omaha, Nebraska, United States, 68124
      • CHI Health Clinic Pulmonary
  • New Jersey
    • Brick, New Jersey, United States, 08724
      • Ocean Allergy & Respiratory Research Center
    • Ocean City, New Jersey, United States, 07712
      • Atlantic Research Center, LLC
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Brooklyn, New York, United States, 11209
      • A Atat Progressive Pulmonary & Sleep Medicine
    • Glendale, New York, United States, 11385
      • New York Allergy and Sinus Centers
    • Great Neck, New York, United States, 11021
      • Northwell Health Division of Allergy & Immunology
    • Manhasset, New York, United States, 11030
      • Northwell Health Physician Partners Pulmonary Medicine and Cardiology at Manhasset
    • Mineola, New York, United States, 11501
      • NYU Langone Hospital - Long Island
    • Oakland Gardens, New York, United States, 11364
      • Summit Health
    • Rochester, New York, United States, 14607
      • RRH Allergy, Immunology & Rheumatology
    • Rockville Centre, New York, United States, 11570
      • Allergy & Asthma Care of LI
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Allergy Partners of Western North Carolina
    • Cary, North Carolina, United States, 27518
      • Allergy Partners of the Triangle
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Children's Hospital
    • Charlotte, North Carolina, United States, 28210
      • Javara Inc. and Tryon Medical Partners, PLLC
    • Winston-Salem, North Carolina, United States, 27104
      • Airways Clinical Research Center
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Children's Hospital Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73131
      • Oklahoma Institute of Allergy and Asthma Clinical Research, LLC
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma and Clinical Research Center
  • Oregon
    • Happy Valley, Oregon, United States, 97086
      • Portland Research
  • Pennsylvania
    • Blue Bell, Pennsylvania, United States, 19422
      • Allergy and Asthma Specialists, P.C.
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Columbo Asthma, Allergy and Immunology, LLC
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Asthma, Nasal Disease & Allergy Research Center of New England
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma Research, LLC
    • Summerville, South Carolina, United States, 29486
      • Charleston ENT Associates, LLC
  • Texas
    • Houston, Texas, United States, 77029
      • Precision Research Institute, LLC
    • San Antonio, Texas, United States, 78229
      • STAAMP Research, LLC
    • San Antonio, Texas, United States, 78258
      • Element Research Group
  • Utah
    • Layton, Utah, United States, 84041
      • Tanner Clinic
    • Murray, Utah, United States, 84107
      • Allergy Associates of Utah
  • Washington
    • Seattle, Washington, United States, 98115
      • Seattle Allergy & Asthma Research Institute
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demography	Including gender, age, race	At Baseline
Baseline Characteristics	Including prior medications and procedures, medical history, asthma history, weight, height	At Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Treatment Characteristics	Including but not limited to treatment dose, frequency, duration and asthma treatment associations.	At Baseline
Incidence of adverse events (AEs)	Including but not limited to: frequency, percentage and exposure-adjusted incidence rate of AEs	Baseline up to 3 years
Physician Assessment: - Spirometry	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.	Baseline up to 3 years
Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)	Assessment collected as per standard of care.	Baseline up to 3 Years
Patient Reported Outcome: Asthma Control Questionnaire, 6-item (ACQ-6)	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.	Baseline up to 3 Years
Patient Reported Outcome: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)	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.	Baseline up to 3 Years
Patient Reported Outcome: Global Patient Assessment	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.	Baseline up to 3 Years
Patient Reported Outcome: Physical Activity Limitation Questionnaire (PALQ)	Assessing patient's physical activity in their free time. Higher score indicates more health-related quality of life impairment.	Baseline up to 3 Years
Patient Reported Outcome in patients with allergic rhinitis: Allergic Rhinitis Visual Analog Scale (AR-VAS)	Assessing severity of rhinits symptoms where higher score indicates more bothersome allergic symptoms.	Baseline up to 3 Years
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)	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.	Baseline up to 3 Years
Patient Reported Outcome in patients with chronic (rhino) sinusitis and/or nasal polyps: Sino-Nasal Outcome Test (SNOT-22)	Questionnaire to assess the impact of chronic rhinosinusitis on quality of life. Lower score represents better health related quality of life.	Baseline up to 3 Years
Patient Reported Outcome in patients with atopic dermatitis: Patient Oriented Eczema Measure (POEM)	Questionnaire assessing eczema severity with lower score representing impact of lower severity of less severe eczema.	Baseline up to 3 Years
Patient Reported Outcome: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-asthma)	Questionnaire to measure impairments in work and activities with higher score indicating greater impairment and less productivity.	Baseline up to 3 Years
Healthcare Utilization: Healthcare Resource Utilization Questionnaire (HCRUQ)	The HCRUQ collects information on unscheduled healthcare resource encounters related to asthma	Baseline up to 3 years

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Collaborators: Sanofi
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Estimated): July 7, 2026
• Study Completion (Estimated): July 7, 2026

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Primary Indication of Asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: R668-AS-1885; EUPAS41963 (Other Identifier: ENCePP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No