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 Center of Alabama, LLC
🇺🇸Birmingham, Alabama, United States
Arizona Allergy & Immunology Research
🇺🇸Gilbert, Arizona, United States
Medical Research of Arizona, a Division of Allergy, Asthma & Immunology Associates, Ltd.
🇺🇸Scottsdale, Arizona, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Riviera Allergy Medical Center
🇺🇸Redondo Beach, California, United States
Allergy & Asthma Medical Group and Research, A PC
🇺🇸San Diego, California, United States
Bensch Clinical Research, LLC
🇺🇸Stockton, California, United States
Allianz Research Institute, Inc.
🇺🇸Westminster, California, United States
Global Research Solutions
🇺🇸Hollywood, Florida, United States
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Scroll for more (118 remaining)Clinical Research Center of Alabama, LLC🇺🇸Birmingham, Alabama, United States