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RAPID: Registry of Asthma Patients Initiating DUPIXENT®

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04287621
Collaborator
Sanofi (Industry)
1,000
Enrollment
95
Locations
66.5
Anticipated Duration (Months)
10.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

Detailed Description

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

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Registry of Asthma Patients Initiating DUPIXENT® (RAPID)
Actual Study Start Date :
Mar 2, 2020
Anticipated Primary Completion Date :
Sep 16, 2025
Anticipated Study Completion Date :
Sep 16, 2025

Outcome Measures

Primary Outcome Measures

  1. Demography [At Baseline]

    Including gender, age, race

  2. Baseline Characteristics [At Baseline]

    Including prior medications and procedures, medical history, asthma history, weight, height

Secondary Outcome Measures

  1. Baseline Treatment Characteristics [At Baseline]

    Including but not limited to treatment dose, frequency, duration and asthma treatment associations.

  2. Incidence of adverse events (AEs) [Baseline up to 3 years]

    Including but not limited to: frequency, percentage and exposure-adjusted incidence rate of AEs

  3. 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.

  4. Physician Assessment: Fractional exhaled Nitric Oxide (FeNO) [Baseline up to 3 Years]

    Assessment collected as per standard of care.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Healthcare Utilization: Healthcare Resource Utilization Questionnaire (HCRUQ) [Baseline up to 3 years]

    The HCRUQ collects information on unscheduled healthcare resource encounters related to asthma

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Research Center of Alabama, LLC Birmingham Alabama United States 35209
2 Arizona Allergy & Immunology Research Gilbert Arizona United States 85234
3 Medical Research of Arizona, a Division of Allergy, Asthma & Immunology Associates, Ltd. Scottsdale Arizona United States 85251
4 Banner University of Arizona Medical Center Tucson Arizona United States 85724
5 Stuart Z. Epstein, MD Beverly Hills California United States 90212
6 Riviera Allergy Medical Center Redondo Beach California United States 90277
7 Sacramento ENT Roseville California United States 95661
8 Allergy & Asthma Medical Group and Research, A PC San Diego California United States 92123
9 Bensch Clinical Research, LLC Stockton California United States 95207
10 Allianz Research Institute, Inc. Westminster California United States 92683
11 Waterbury Pulmonary Associates Waterbury Connecticut United States 06708
12 TOPAZ Clinical Research, Inc. Apopka Florida United States 32703
13 Global Research Solutions Hollywood Florida United States 33021
14 Coral Way Research, LLC Miami Florida United States 33155
15 Rejuvaline Medical Research Miami Florida United States 33155
16 Care Research Center Miami Florida United States 33175
17 Palmetto Professional Research Miami Florida United States 33186
18 Kratz Allergy & Asthma Port Richey Florida United States 34653
19 GCP, Global Clinical Professionals Saint Petersburg Florida United States 33702
20 Allergy & Asthma Diagnostic Treatment Center Tallahassee Florida United States 32308
21 Emigent Research Center Inc Tampa Florida United States 33614
22 Georgia Pollens Clinical Research Centers, Inc. Albany Georgia United States 31707
23 Columbus Regional Research Institute Columbus Georgia United States 31904
24 IACT Health Southeast Lung Associates Rincon Georgia United States 31326
25 Treasure Valley Medical Research Boise Idaho United States 83706
26 Northwestern Medical Group Allergy & Immunology Clinic Chicago Illinois United States 60611
27 NorthShore University Health System Evanston Illinois United States 60201
28 Asthma and Allergy Center of Chicago Oak Park Illinois United States 60301
29 Riley Hospital for Children at Indiana University Health Indianapolis Indiana United States 46202
30 Kansas City Allergy and Asthma Associates, PA Overland Park Kansas United States 66210
31 Dr. Henry J. Kanarek Allergy, Asthma & Immunology Overland Park Kansas United States 66211
32 Family Allergy and Asthma Louisville Kentucky United States 40291
33 Allergy & Asthma Specialists, PSC Owensboro Kentucky United States 42301
34 Institute for Asthma & Allergy, PC Chevy Chase Maryland United States 20815
35 Schreiber Allergy Rockville Maryland United States 20850
36 Virgo-Carter Pediatrics Silver Spring Maryland United States 20910
37 Chesapeake Clinical Research, Inc. White Marsh Maryland United States 21162
38 University of Michigan Allergy Specialty Clinic and Food Allergy Clinic Ann Arbor Michigan United States 48106
39 University of Michigan Ann Arbor Michigan United States 48109
40 Oakland Medical Research Troy Michigan United States 48085
41 Allergy and Asthma Center of Minnesota Maplewood Minnesota United States 55109
42 ENT & Allergy Center of Missouri Columbia Missouri United States 65201
43 St. Louis Children's Hospital Saint Louis Missouri United States 63110
44 The Clinical Research Center, LLC Saint Louis Missouri United States 63141
45 Nebraska Medical Research Institute, Inc. Bellevue Nebraska United States 68123
46 Ocean Allergy & Respiratory Research Center Brick New Jersey United States 08724
47 Montefiore Medical Center Bronx New York United States 10461
48 New York Allergy and Sinus Centers Glendale New York United States 11385
49 Northwell Health Division of Allergy & Immunology Great Neck New York United States 11021
50 NYU Langone Hospital - Long Island Mineola New York United States 11501
51 RRH Allergy, Immunology & Rheumatology Rochester New York United States 14607
52 Allergy Partners of Western North Carolina Asheville North Carolina United States 28801
53 UNC Children's Hospital Chapel Hill North Carolina United States 27599
54 Javara Inc. and Tryon Medical Partners, PLLC Charlotte North Carolina United States 28210
55 Airways Clinical Research Center Winston-Salem North Carolina United States 27104
56 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45220
57 Clinical Research Solutions Middleburg Heights Ohio United States 44130
58 Allergy, Asthma and Clinical Research Center Oklahoma City Oklahoma United States 73120
59 Oklahoma Institute of Allergy and Asthma Clinical Research, LLC Oklahoma City Oklahoma United States 73131
60 Vital Prospects Clinical Research Institute, PC Tulsa Oklahoma United States 74136
61 Portland Research Happy Valley Oregon United States 97086
62 Allergy and Asthma Specialists, P.C. Blue Bell Pennsylvania United States 19422
63 Columbo Asthma, Allergy and Immunology, LLC Bryn Mawr Pennsylvania United States 19010
64 Asthma, Nasal Disease & Allergy Research Center of New England East Providence Rhode Island United States 02914
65 National Allergy and Asthma Research, LLC North Charleston South Carolina United States 29420
66 Medical Research South, LLC Summerville South Carolina United States 29486
67 Clinical Research Solutions Jackson Tennessee United States 38305
68 Clinical Research Solutions Milan Tennessee United States 38358
69 Orion Clinical Research Austin Texas United States 78759
70 Precision Research Institute, LLC Houston Texas United States 77029
71 STAAMP Research, LLC San Antonio Texas United States 78229
72 Element Research Group San Antonio Texas United States 78258
73 Sugar Land Allergy, Asthma, and Immunology Center Sugar Land Texas United States 77479
74 Tanner Clinic Layton Utah United States 84041
75 Suffolk Multispecialty Research David Ramstad & Associates Suffolk Virginia United States 23435
76 Seattle Allergy & Asthma Research Institute Seattle Washington United States 98115
77 Gundersen Health System La Crosse Wisconsin United States 54601
78 BLC Clinical Research Burlington Ontario Canada L7N 3V2
79 Evidence Based Medical Educator Inc. Toronto Ontario Canada M5G 1E2
80 Inspiration Research Limited Toronto Ontario Canada M5T 3A9
81 Dr. Syeed Anees Medicine Professional Corporation Windsor Ontario Canada N8X 1T3
82 Sygehus Lillebaelt - Vejle Sygehus - Lungemedicinsk afdeling Vejle Denmark 7100
83 Centre Hospitalier du Pays d'Aix - Maladies Respiratoires Aix-en-Provence France 13100
84 Istituto Clinico Himanitas, Humanitas Mirasole S.p.a. Rozzano Lombardia Italy 20089
85 Azienda Sanitaria Locale Salerno Battipaglia Salerno Italy 84091
86 Dokkyo Medical University Hospital Mibu Tochigi Japan 321-0293
87 Incorporated Medical Corporation, Shishin Iryokai, Respiratory Care Clinic Tokyo Chuo-ku Tokyo Japan 104-0031
88 Incorporated Medical Corporation, Jinyukai, Jinyu Clinic Nakano ku Tokyo Japan 164-0012
89 CardioPulmonary Research CSP Guaynabo Puerto Rico 00968
90 Instituto Pulmonary Diseases Torre Medica San Lucas Ponce Puerto Rico 00731
91 Rafael H Zaragoza - Urdaz San Juan Puerto Rico 00918
92 Fundacion de Investigacion de Diego San Juan Puerto Rico 00927
93 University of Puerto Rico Medical Sciences Campus San Juan Puerto Rico 00936
94 Fysikalisk Medicin Lidingö Stockholms Län [se-01] Sweden SE-181 58
95 Karolinska Universitetssjukhuset - Astrid Lindgrens barnsjukhus Solna Stockholms Län [se-01] Sweden SE-171 76

Sponsors and Collaborators

  • Regeneron Pharmaceuticals
  • Sanofi

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04287621
Other Study ID Numbers:
  • R668-AS-1885
  • EUPAS41963
First Posted:
Feb 27, 2020
Last Update Posted:
Jul 22, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Regeneron Pharmaceuticals
Primary Indication of Asthma
Additional relevant MeSH terms:
Asthma

Study Results

No Results Posted as of Jul 22, 2022