An observational study of ORALAIR® (Grass pollen allergen extract from: Cocksfoot, Sweet Vernal, Rye Grass, Meadow Grass, Timothy) tablet for sublingual use in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis (SL74.14)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (V01AA02) grass pollen

  grass pollen
• Medical condition to be studied:
  Seasonal allergy

Population studied

• Short description of the study population:
  Allergen immunotherapy naive male or female outpatients aged 5 to 9 years (inclusive) prescribed with Oralair®.
• Age groups:
  • Children (2 to < 12 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Seasonal allergy patients
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The purpose of this study is to further describe the safety and tolerability of ORALAIR tablets for sublingual use in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis with or without conjunctivitis.
• Outcomes:
  All adverse events that started on or after the day the first dose of ORALAIR.
• Data analysis plan:
  An overall summary of all AEs, including the number of events and the number and percentage of patients with AEs will be provided. AEs will be summarized by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT). Additional tables will summarize AEs by severity grade and relationship to the treatment. Tables summarizing Serious Adverse Events and AEs leading to study withdrawal will also be provided. Detailed patient listings of all AEs will be provided including the onset date and time, the duration of the reaction and the time interval since previous dose of Oralair intake.