Registry of Asthma Patients Initiating DUPIXENT® (RAPID)

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

• Medicinal product name:
  DUPIXENT
• 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:
  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.