A non-interventional observational study assessing the safety and tolerability of ACARIZAX® in adults (18-65 years of age) (RELIEF)

Study type

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

  Other
• If ‘other’, further details on the scope of the study:
  Satisfaction, convenience, compliance and therapeutic effect

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational, multi-centric, open-label study

Study drug and medical condition

• Name of medicine, other:
  Itulazax
• Medical condition to be studied:
  Conjunctivitis allergic

  Seasonal allergy

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  collecting safety data of Itulazax in daily practise in patients aged 18-65 years of age.
• Outcomes:
  number, kind (MedDRA coding) and assessment of adverse events reported. Per protocol patient and physician satisfaction were asked at end of study or if patient stopped early. estimation by physician of patient compliance at each visit. Control of Allergic Rhinitis and Asthma Test (CARAT score) a measure of disease control and thus of therapeutic effect was also asked at each visit.
• Data analysis plan:
  Demographics and other baseline characteristics will be displayed with summary statistics (i.e. number of patients, minimum, maximum, mean, median, 25% and 75% percentiles) and frequency tables for categorical variables. AEs as well as breakdown of AEs according to seriousness, severity and causality will be summarised for all AEs and for AEs during administration. AEs will be summarised by system organ class and preferred term and displaying number of patients and frequency of patients having AEs as well as number of AEs. Other statistics will be summarised as well.