Assessment of Oralair® use in real-life (EVORA)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  GRASS POLLEN ALLERGEN EXTRACT
• Anatomical Therapeutic Chemical (ATC) code:
  (V01AA02) grass pollen

  grass pollen
• Medical condition to be studied:
  Rhinitis allergic

Population studied

• Short description of the study population:
  Allergic rhinitis with or without conjunctivitis in children (older than 5 years of age) and adults treated with Oralair® in real-life in France.
• Age groups:
  Children (2 to < 12 years)

  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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with allergic rhinitis
• Estimated number of subjects:
  450

Study design details

• Main study objective:
  To describe the prescription patterns of Oralair®: indication, dosage, date of drug initiation compared to pollen season, concomitant drugs including antihistamines, local corticosteroids, cromones, and decongestants
• Data analysis plan:
  Statistical analysis will be carried out by the Bordeaux pharmacoepi according to a documented and approved Statistical Analysis Plan (SAP). The SAP describes statistical analysis as foreseen at the time of planning study. Statistical analysis will be performed after database lock using SAS® software (SAS Institute, last version, North Carolina, USA). Statistical analysis will be conducted separately for children and for adults. Qualitative variables (binary or categorical) and ordinal variables will be described in terms of number and frequency. Quantitative variables will be described in terms of number, mean, standard deviation, median and extreme values. The 95% confidence interval will be calculated for the relevant parameters.

Documents

Study publications

Blin P, Demoly P, Drouet M, Falissard B, Lignot-Maleyran S, Maizi H, Lorrain S,…