Clinical trial NCT04287621: Registry of Asthma Patients Initiating DUPIXENT®
Official title: Registry of Asthma Patients Initiating DUPIXENT® (RAPID)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Asthma
Keywords: Primary Indication of Asthma
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2020-02-27
Enrollment: 718
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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

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.

Primary outcomes:
measure: Demography
timeFrame: At Baseline
measure: Baseline Characteristics
timeFrame: At Baseline
Secondary outcomes:
measure: Baseline Treatment Characteristics
timeFrame: At Baseline
measure: Incidence of adverse events (AEs)
timeFrame: Baseline up to 3 years
measure: Physician Assessment: - Spirometry
timeFrame: Baseline up to 3 years
measure: Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)
timeFrame: Baseline up to 3 Years
measure: Patient Reported Outcome: Asthma Control Questionnaire, 6-item (ACQ-6)
timeFrame: Baseline up to 3 Years
measure: Patient Reported Outcome: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
timeFrame: Baseline up to 3 Years
measure: Patient Reported Outcome: Global Patient Assessment
timeFrame: Baseline up to 3 Years
measure: Patient Reported Outcome: Physical Activity Limitation Questionnaire (PALQ)
timeFrame: Baseline up to 3 Years
measure: Patient Reported Outcome in patients with allergic rhinitis: Allergic Rhinitis Visual Analog Scale (AR-VAS)
timeFrame: Baseline up to 3 Years
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)
timeFrame: Baseline up to 3 Years
measure: Patient Reported Outcome in patients with chronic (rhino) sinusitis and/or nasal polyps: Sino-Nasal Outcome Test (SNOT-22)
timeFrame: Baseline up to 3 Years
measure: Patient Reported Outcome in patients with atopic dermatitis: Patient Oriented Eczema Measure (POEM)
timeFrame: Baseline up to 3 Years
measure: Patient Reported Outcome: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-asthma)
timeFrame: Baseline up to 3 Years
measure: Healthcare Utilization: Healthcare Resource Utilization Questionnaire (HCRUQ)
timeFrame: Baseline up to 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama, LLC
state: Alabama
city: Gilbert
country: United States
facility: Arizona Allergy & Immunology Research
state: Arizona
city: Scottsdale
country: United States
facility: Medical Research of Arizona, a Division of Allergy, Asthma & Immunology Associates, Ltd.
state: Arizona
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Redondo Beach
country: United States
facility: Riviera Allergy Medical Center
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research, A PC
state: California
city: Stockton
country: United States
facility: Bensch Clinical Research, LLC
state: California
city: Westminster
country: United States
facility: Allianz Research Institute, Inc.
state: California
city: Hollywood
country: United States
facility: Global Research Solutions
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Kissimmee
country: United States
facility: Clinical Research Specialists, LLC
state: Florida
city: Port Richey
country: United States
facility: Kratz Allergy & Asthma
state: Florida
city: Saint Petersburg
country: United States
facility: GCP, Global Clinical Professionals
state: Florida
city: Tallahassee
country: United States
facility: Allergy & Asthma Diagnostic Treatment Center
state: Florida
city: Atlanta
country: United States
facility: Omni Allergy
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Rincon
country: United States
facility: IACT Health Southeast Lung Associates
state: Georgia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Chicago
country: United States
facility: Northwestern Medical Group Allergy & Immunology Clinic
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Oak Park
country: United States
facility: Asthma and Allergy Center of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children at Indiana University Health
state: Indiana
city: Overland Park
country: United States
facility: Velocity Clinical Research
state: Kansas
city: Overland Park
country: United States
facility: Dr. Henry J. Kanarek Allergy, Asthma & Immunology
state: Kansas
city: Louisville
country: United States
facility: Family Allergy and Asthma
state: Kentucky
city: Owensboro
country: United States
facility: Allergy & Asthma Specialists, PSC
state: Kentucky
city: Rockville
country: United States
facility: Schreiber Allergy
state: Maryland
city: Silver Spring
country: United States
facility: Virgo-Carter Pediatrics
state: Maryland
city: White Marsh
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Allergy Specialty Clinic and Food Allergy Clinic
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Maplewood
country: United States
facility: Allergy and Asthma Center of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Columbia
country: United States
facility: ENT & Allergy Center of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Bellevue
country: United States
facility: Nebraska Medical Research Institute, Inc.
state: Nebraska
city: Omaha
country: United States
facility: CHI Health Clinic Pulmonary
state: Nebraska
city: Brick
country: United States
facility: Ocean Allergy & Respiratory Research Center
state: New Jersey
city: Ocean City
country: United States
facility: Atlantic Research Center, LLC
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: A Atat Progressive Pulmonary & Sleep Medicine
state: New York
city: Glendale
country: United States
facility: New York Allergy and Sinus Centers
state: New York
city: Great Neck
country: United States
facility: Northwell Health Division of Allergy & Immunology
state: New York
city: Manhasset
country: United States
facility: Northwell Health Physician Partners Pulmonary Medicine and Cardiology at Manhasset
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island
state: New York
city: Oakland Gardens
country: United States
facility: Summit Health
state: New York
city: Rochester
country: United States
facility: RRH Allergy, Immunology & Rheumatology
state: New York
city: Rockville Centre
country: United States
facility: Allergy & Asthma Care of LI
state: New York
city: Asheville
country: United States
facility: Allergy Partners of Western North Carolina
state: North Carolina
city: Cary
country: United States
facility: Allergy Partners of the Triangle
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Children's Hospital
state: North Carolina
city: Charlotte
country: United States
facility: Javara Inc. and Tryon Medical Partners, PLLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Airways Clinical Research Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma and Clinical Research Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Institute of Allergy and Asthma Clinical Research, LLC
state: Oklahoma
city: Happy Valley
country: United States
facility: Portland Research
state: Oregon
city: Blue Bell
country: United States
facility: Allergy and Asthma Specialists, P.C.
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Columbo Asthma, Allergy and Immunology, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: East Providence
country: United States
facility: Asthma, Nasal Disease & Allergy Research Center of New England
state: Rhode Island
city: North Charleston
country: United States
facility: National Allergy and Asthma Research, LLC
state: South Carolina
city: Summerville
country: United States
facility: Charleston ENT Associates, LLC
state: South Carolina
city: Houston
country: United States
facility: Precision Research Institute, LLC
state: Texas
city: San Antonio
country: United States
facility: STAAMP Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Element Research Group
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Murray
country: United States
facility: Allergy Associates of Utah
state: Utah
city: Seattle
country: United States
facility: Seattle Allergy & Asthma Research Institute
state: Washington
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
city: Vancouver
country: Canada
facility: The University of British Columbia
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Burlington
country: Canada
facility: BLC Clinical Research
state: Ontario
city: Toronto
country: Canada
facility: Evidence Based Medical Educator Inc.
state: Ontario
city: Toronto
country: Canada
facility: Inspiration Research Limited
state: Ontario
city: Windsor
country: Canada
facility: Dr. Syeed Anees Medicine Professional Corporation
state: Ontario
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) - Universite Laval
city: Vejle
country: Denmark
facility: Sygehus Lillebaelt - Vejle Sygehus - Lungemedicinsk afdeling
city: Aix-en-Provence
country: France
facility: Centre Hospitalier du Pays d'Aix - Maladies Respiratoires
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Dijon
country: France
facility: Centre Hospitalier Universitaire Dijon Bourgogne (CHU Dijon) - Hôpital Francois Mitterrand
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
city: Marseille
country: France
facility: Hôpital Nord
city: Montivilliers
country: France
facility: Hopital Jacques Monod
city: Milano
country: Italy
facility: Ospedale dei Bambini Vittore Buzzi ASST Fatebenefratelli Sacco
state: Lombardia
city: Milano
country: Italy
facility: Ospedale Luigi Sacco, PU, ASST Fatebenefratelli Sacco
state: Lombardia
city: Pavia
country: Italy
facility: La Fondazione IRCCS Policlinico "San Matteo"
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Himanitas, Humanitas Mirasole S.p.a.
state: Lombardia
city: Ancona
country: Italy
facility: Istituto Nazionale di Riposo e Cura per Anziani
state: Marche
city: Bari
country: Italy
facility: Fondazione Salvatore Maugeri
state: Puglia
city: Battipaglia
country: Italy
facility: Azienda Sanitaria Locale Salerno
state: Salerno
city: Kiyosu-shi
country: Japan
facility: Hansaki Clinic
state: Aichi
city: Kita-ku
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Mibu
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: Incorporated Medical Corporation, Shishin Iryokai, Respiratory Care Clinic Tokyo
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Nakano ku
country: Japan
facility: Incorporated Medical Corporation, Jinyukai, Jinyu Clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Sumida-ku
country: Japan
facility: The Fraternity Memorial Hospital
state: Tokyo
city: Cayey
country: Puerto Rico
facility: Agosto Allergy and Immunology
city: Guaynabo
country: Puerto Rico
facility: CardioPulmonary Research CSP
city: Ponce
country: Puerto Rico
facility: Instituto Pulmonary Diseases Torre Medica San Lucas
city: San Juan
country: Puerto Rico
facility: Rafael H Zaragoza - Urdaz
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Medical Sciences Campus
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Catalonia
city: A Coruña
country: Spain
facility: Complexo Hospialario Universitario A Coruña
state: Galicia
city: Lidingö
country: Sweden
facility: Fysikalisk Medicin
state: Stockholms Län [se-01]
city: Manchester
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
state: Greater Manchester
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Exeter
country: United Kingdom
facility: Royal Devon University Healthcare NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
city: Leeds
country: United Kingdom
facility: St. James Hospital Leeds
city: Leicester
country: United Kingdom
facility: Glenfield General Hospital
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: