Study type

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Patient Characterization of population receiving therapy and evaluations of safety and effectiveness
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Observational prospective product registry
Study drug and medical condition

Medical condition to be studied

Asthma
Population studied

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

1000
Study design details

Main study objective

This is a prospective global product registry, designed to collect data regarding the characteristics of patients who initiate DUPIXENT for asthma according to the country-specific prescribing information, real-world use patterns for DUPIXENT and any co-treatments, and long-term data on DUPIXENT’s safety and effectiveness in the real-world setting.

Outcomes

• Demography • Baseline Characteristics, • Baseline Treatment Characteristics • Incidence of AEs • Physician Assessments: Spirometry & FeNO • Patient Reported Outcomes (PRO): ACQ-6, MiniAQLQ, Global Patient Assessments, PALQ, & WPAI-asthma • PRO (allergic rhinitis): AR-VAS, RQLQS+12 • PRO (chronic (rhino) sinusitis +/- nasal polyps): SNOT-22 • PRO (AD): POEM • Healthcare Utilization: HCRUQ See ClinicalTrials.gov NCT04287621

Data analysis plan

Data collected in this registry will be analyzed descriptively.