ITULAZAX Post Authorization Safety (IPAS) Study: A prospective, non-interventional study assessing the safety and tolerability of ITULAZAX in adults with tree pollen allergy in real-life practice (IPAS Study)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational, multi-site, open-label multinational PASS

Study drug and medical condition

• Name of medicine, other:
  ITULAZAX
• Medical condition to be studied:
  Rhinitis allergic

Population studied

• Short description of the study population:
  Adults patients aged 18-65 years old who were prescribed with ITULAZAX in a real-life setting in Germany, the Netherlands, Denmark, Sweden, Norway and Finland.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with allergies
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To investigate the safety and tolerability of the ITULAZAX in adults (18-65 years of age) in the first 4-6 months of treatment in a real-life setting.
• Outcomes:
  Sum of pre-specified local adverse drug reactions (including lip swelling/oedema, mouth oedema, palatal oedema, swollen tongue/oedema, oropharyngeal swelling (oedema, pharyngeal oedema/throat tightness), laryngeal oedema), Number of treatment related AEs • Number of systemic reactions • Number of non-local adverse drug reactions • Number of serious AEs (SAEs) • Sum of pre-specified local adverse reactions (as specified in the primary endpoint) within the first 4 months of treatment in patients with history of Pollen Food Syndrome (PFS) • Adherence to the first 4 months of treatment.
• Data analysis plan:
  AEs as well as breakdown of AEs and treatment-related AEs (possibly related) according to seriousness, severity and causality will be summarised for AEs during administration (V1 to V4). AEs will be summarised by MedDRA System Organ Classes and MedDRA Preferred Terms displaying number of patients, frequency of patients having AEs as well as number of AEs.

Documents

Study results

2023-06-09_NI-TT-01_Overall Study Report ITULAZAX_Synopsis_Final version