Registry of Asthma Patients Initiating DUPIXENT®

Asthma Clinical Trial

— RAPID  

Official title:

Registry of Asthma Patients Initiating DUPIXENT® (RAPID)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04287621
• Other study ID #: R668-AS-1885
• Secondary ID: EUPAS41963
• Status: Active, not recruiting
• Start date: March 2, 2020
• Est. completion date: July 7, 2026

Study information

• Verified date: October 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 718
• Est. completion date: July 7, 2026
• Est. primary completion date: July 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• DUPIXENT®
There is no investigational product provided by the study sponsor and no therapeutic intervention regulated by this protocol. As a condition for eligibility, patients are required to initiate DUPIXENT® for asthma, according to the country-specific prescribing information, prescribed by their physician as part of their normal care (ie, not for the purpose of enrolling in the registry). Once patients enter the study, there are no protocol requirements regarding DUPIXENT® or any other treatments.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  France,  Italy,  Japan,  Puerto Rico,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demography	Including gender, age, race	At Baseline
Primary	Baseline Characteristics	Including prior medications and procedures, medical history, asthma history, weight, height	At Baseline
Secondary	Baseline Treatment Characteristics	Including but not limited to treatment dose, frequency, duration and asthma treatment associations.	At Baseline
Secondary	Incidence of adverse events (AEs)	Including but not limited to: frequency, percentage and exposure-adjusted incidence rate of AEs	Baseline up to 3 years
Secondary	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
Secondary	Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)	Assessment collected as per standard of care.	Baseline up to 3 Years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Healthcare Utilization: Healthcare Resource Utilization Questionnaire (HCRUQ)	The HCRUQ collects information on unscheduled healthcare resource encounters related to asthma	Baseline up to 3 years