Registry of Asthma Patients Initiating DUPIXENT®
- Conditions
- Asthma
- Registration Number
- NCT04287621
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 718
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Demography At Baseline Including gender, age, race
Baseline Characteristics At Baseline Including prior medications and procedures, medical history, asthma history, weight, height
- Secondary Outcome Measures
Name Time Method Physician Assessment: - Spirometry Baseline up to 3 years 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.
Patient Reported Outcome: Asthma Control Questionnaire, 6-item (ACQ-6) Baseline up to 3 Years 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 Treatment Characteristics At Baseline Including but not limited to treatment dose, frequency, duration and asthma treatment associations.
Incidence of adverse events (AEs) Baseline up to 3 years Including but not limited to: frequency, percentage and exposure-adjusted incidence rate of AEs
Physician Assessment: Fractional exhaled Nitric Oxide (FeNO) Baseline up to 3 Years Assessment collected as per standard of care.
Patient Reported Outcome in patients with chronic (rhino) sinusitis and/or nasal polyps: Sino-Nasal Outcome Test (SNOT-22) Baseline up to 3 Years Questionnaire to assess the impact of chronic rhinosinusitis on quality of life. Lower score represents better health related quality of life.
Patient Reported Outcome: Mini Asthma Quality of Life Questionnaire (MiniAQLQ) Baseline up to 3 Years 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.
Patient Reported Outcome: Global Patient Assessment Baseline up to 3 Years 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.
Patient Reported Outcome: Physical Activity Limitation Questionnaire (PALQ) Baseline up to 3 Years Assessing patient's physical activity in their free time. Higher score indicates more health-related quality of life impairment.
Patient Reported Outcome in patients with allergic rhinitis: Allergic Rhinitis Visual Analog Scale (AR-VAS) Baseline up to 3 Years Assessing severity of rhinits symptoms where higher score indicates more bothersome allergic symptoms.
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) Baseline up to 3 Years 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.
Patient Reported Outcome: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-asthma) Baseline up to 3 Years Questionnaire to measure impairments in work and activities with higher score indicating greater impairment and less productivity.
Patient Reported Outcome in patients with atopic dermatitis: Patient Oriented Eczema Measure (POEM) Baseline up to 3 Years Questionnaire assessing eczema severity with lower score representing impact of lower severity of less severe eczema.
Healthcare Utilization: Healthcare Resource Utilization Questionnaire (HCRUQ) Baseline up to 3 years The HCRUQ collects information on unscheduled healthcare resource encounters related to asthma
Trial Locations
- Locations (128)
Clinical Research Specialists, LLC
🇺🇸Kissimmee, Florida, United States
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
Northwell Health Division of Allergy & Immunology
🇺🇸Great Neck, New York, United States
Allergy Partners of the Triangle
🇺🇸Cary, North Carolina, United States
Evidence Based Medical Educator Inc.
🇨🇦Toronto, Ontario, Canada
Inspiration Research Limited
🇨🇦Toronto, Ontario, Canada
La Fondazione IRCCS Policlinico "San Matteo"
🇮🇹Pavia, Lombardia, Italy
CardioPulmonary Research CSP
🇵🇷Guaynabo, Puerto Rico
The Fraternity Memorial Hospital
🇯🇵Sumida-ku, Tokyo, Japan
Rafael H Zaragoza - Urdaz
🇵🇷San Juan, Puerto Rico
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Element Research Group
🇺🇸San Antonio, Texas, United States
STAAMP Research, LLC
🇺🇸San Antonio, Texas, United States
Velocity Clinical Research
🇺🇸Overland Park, Kansas, United States
Children's Hospital of Orange County
🇺🇸Orange, California, 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
Omni Allergy
🇺🇸Atlanta, Georgia, United States
Clinical Research Center of Alabama, LLC
🇺🇸Birmingham, Alabama, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
Dr. Henry J. Kanarek Allergy, Asthma & Immunology
🇺🇸Overland Park, Kansas, United States
Riviera Allergy Medical Center
🇺🇸Redondo Beach, California, United States
Kratz Allergy & Asthma
🇺🇸Port Richey, Florida, United States
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
IACT Health Southeast Lung Associates
🇺🇸Rincon, Georgia, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
New York Allergy and Sinus Centers
🇺🇸Glendale, New York, United States
Allergy and Asthma Center of Minnesota
🇺🇸Maplewood, Minnesota, United States
The Clinical Research Center, LLC
🇺🇸Saint Louis, Missouri, United States
ENT & Allergy Center of Missouri
🇺🇸Columbia, Missouri, United States
Ocean Allergy & Respiratory Research Center
🇺🇸Brick, New Jersey, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
RRH Allergy, Immunology & Rheumatology
🇺🇸Rochester, New York, United States
NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
National Allergy and Asthma Research, LLC
🇺🇸North Charleston, South Carolina, United States
Summit Health
🇺🇸Oakland Gardens, New York, United States
Asthma, Nasal Disease & Allergy Research Center of New England
🇺🇸East Providence, Rhode Island, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Columbo Asthma, Allergy and Immunology, LLC
🇺🇸Bryn Mawr, Pennsylvania, United States
Charleston ENT Associates, LLC
🇺🇸Summerville, South Carolina, United States
Centre Hospitalier du Pays d'Aix - Maladies Respiratoires
🇫🇷Aix-en-Provence, France
Azienda Sanitaria Locale Salerno
🇮🇹Battipaglia, Salerno, Italy
Hopital Jacques Monod
🇫🇷Montivilliers, France
Istituto Clinico Himanitas, Humanitas Mirasole S.p.a.
🇮🇹Rozzano, Lombardia, Italy
Incorporated Medical Corporation, Jinyukai, Jinyu Clinic
🇯🇵Nakano ku, Tokyo, Japan
Hospital De La Santa Creu I Sant Pau
🇪🇸Barcelona, Catalonia, Spain
Agosto Allergy and Immunology
🇵🇷Cayey, Puerto Rico
Fysikalisk Medicin
🇸🇪Lidingö, Stockholms Län [se-01], Sweden
Royal Devon University Healthcare NHS Foundation Trust
🇬🇧Exeter, United Kingdom
The University of Chicago
🇺🇸Chicago, Illinois, United States
Riley Hospital for Children at Indiana University Health
🇺🇸Indianapolis, Indiana, United States
Asthma and Allergy Center of Chicago
🇺🇸Oak Park, Illinois, United States
Arizona Allergy & Immunology Research
🇺🇸Gilbert, Arizona, United States
Allergy & Asthma Medical Group and Research, A PC
🇺🇸San Diego, California, United States
Allianz Research Institute, Inc.
🇺🇸Westminster, California, United States
Medical Research of Arizona, a Division of Allergy, Asthma & Immunology Associates, Ltd.
🇺🇸Scottsdale, Arizona, United States
Global Research Solutions
🇺🇸Hollywood, Florida, United States
Bensch Clinical Research, LLC
🇺🇸Stockton, California, United States
Northwestern Medical Group Allergy & Immunology Clinic
🇺🇸Chicago, Illinois, United States
GCP, Global Clinical Professionals
🇺🇸Saint Petersburg, Florida, United States
Allergy & Asthma Specialists, PSC
🇺🇸Owensboro, Kentucky, United States
Atlantic Research Center, LLC
🇺🇸Ocean City, New Jersey, United States
Allergy & Asthma Care of LI
🇺🇸Rockville Centre, New York, United States
A Atat Progressive Pulmonary & Sleep Medicine
🇺🇸Brooklyn, New York, United States
Northwell Health Physician Partners Pulmonary Medicine and Cardiology at Manhasset
🇺🇸Manhasset, New York, United States
Allergy Partners of Western North Carolina
🇺🇸Asheville, North Carolina, United States
Javara Inc. and Tryon Medical Partners, PLLC
🇺🇸Charlotte, North Carolina, United States
Portland Research
🇺🇸Happy Valley, Oregon, United States
Allergy and Asthma Specialists, P.C.
🇺🇸Blue Bell, Pennsylvania, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
Precision Research Institute, LLC
🇺🇸Houston, Texas, United States
Seattle Allergy & Asthma Research Institute
🇺🇸Seattle, Washington, United States
Allergy Associates of Utah
🇺🇸Murray, Utah, United States
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
The University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
BLC Clinical Research
🇨🇦Burlington, Ontario, Canada
Dr. Syeed Anees Medicine Professional Corporation
🇨🇦Windsor, Ontario, Canada
Sygehus Lillebaelt - Vejle Sygehus - Lungemedicinsk afdeling
🇩🇰Vejle, Denmark
CHU de Bordeaux
🇫🇷Bordeaux, France
Hôpital de la Croix-Rousse
🇫🇷Lyon, France
Centre Hospitalier Universitaire Dijon Bourgogne (CHU Dijon) - Hôpital Francois Mitterrand
🇫🇷Dijon, France
Hôpital Nord
🇫🇷Marseille, France
Ospedale dei Bambini Vittore Buzzi ASST Fatebenefratelli Sacco
🇮🇹Milano, Lombardia, Italy
Ospedale Luigi Sacco, PU, ASST Fatebenefratelli Sacco
🇮🇹Milano, Lombardia, Italy
Fondazione Salvatore Maugeri
🇮🇹Bari, Puglia, Italy
Istituto Nazionale di Riposo e Cura per Anziani
🇮🇹Ancona, Marche, Italy
Hansaki Clinic
🇯🇵Kiyosu-shi, Aichi, Japan
Dokkyo Medical University Hospital
🇯🇵Mibu, Tochigi, Japan
Nihon University Itabashi Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
Incorporated Medical Corporation, Shishin Iryokai, Respiratory Care Clinic Tokyo
🇯🇵Chuo-ku, Tokyo, Japan
Teikyo University Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Showa University Hospital
🇯🇵Shinagawa-ku, Tokyo, Japan
Pennine Acute Hospitals NHS Trust
🇬🇧Manchester, Greater Manchester, United Kingdom
University of Puerto Rico Medical Sciences Campus
🇵🇷San Juan, Puerto Rico
Hospital Germans Trias i Pujol
🇪🇸Barcelona, Catalonia, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Catalonia, Spain
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Complexo Hospialario Universitario A Coruña
🇪🇸A Coruña, Galicia, Spain
Gartnavel General Hospital
🇬🇧Glasgow, United Kingdom
St. James Hospital Leeds
🇬🇧Leeds, United Kingdom
St. Bartholomew's Hospital
🇬🇧London, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Glenfield General Hospital
🇬🇧Leicester, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Family Allergy and Asthma
🇺🇸Louisville, Kentucky, United States
University of Michigan Allergy Specialty Clinic and Food Allergy Clinic
🇺🇸Ann Arbor, Michigan, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
CHI Health Clinic Pulmonary
🇺🇸Omaha, Nebraska, United States
UNC Children's Hospital
🇺🇸Chapel Hill, North Carolina, United States
Airways Clinical Research Center
🇺🇸Winston-Salem, North Carolina, United States
Allergy & Asthma Diagnostic Treatment Center
🇺🇸Tallahassee, Florida, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Schreiber Allergy
🇺🇸Rockville, Maryland, United States
Virgo-Carter Pediatrics
🇺🇸Silver Spring, Maryland, United States
Chesapeake Clinical Research, Inc.
🇺🇸White Marsh, Maryland, United States
Nebraska Medical Research Institute, Inc.
🇺🇸Bellevue, Nebraska, United States
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ) - Universite Laval
🇨🇦Québec, Canada
Hokkaido University Hospital
🇯🇵Kita-ku, Hokkaido, Japan
Kobe University Hospital
🇯🇵Kobe, Hyogo, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Instituto Pulmonary Diseases Torre Medica San Lucas
🇵🇷Ponce, Puerto Rico
Gundersen Health System
🇺🇸La Crosse, Wisconsin, United States
Guy's Hospital
🇬🇧London, United Kingdom
Montefiore Medical Center
🇺🇸Bronx, New York, United States