Registry of Asthma Patients Initiating DUPIXENT®

Regeneron Pharmaceuticals718 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

718

Conditions

Asthma

Interventions

DUPIXENT®DRUG

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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Demography

Including gender, age, race

Time frame: At Baseline

Baseline Characteristics

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

Time frame: At Baseline

Secondary Outcomes

Baseline Treatment Characteristics

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

Time frame: At Baseline

Incidence of adverse events (AEs)

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

Time frame: Baseline up to 3 years

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.

Time frame: Baseline up to 3 years

Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)

Assessment collected as per standard of care.