Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Other
Safety study (incl. comparative)

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

Cohort
Other

Non-interventional study design, other

Observational prospective product registry
Study drug and medical condition

Name of medicine

DUPIXENT

Medical condition to be studied

Asthma
Population studied

Age groups

  • Paediatric Population (< 18 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

719
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.