Study on feeling according to the patient of allergens specially prepared for individuals (allergenic ‘Named Patient Products’ NPPs) (ERAPP)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ALLERGEN EXTRACT
• Medical condition to be studied:
  Allergic respiratory disease

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
    • Children (2 to < 12 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  80000

Study design details

• Main study objective:
  To evaluate the impact of an allergen sublingual immunotherapy by NPPs in terms of patient feeling in relation to his allergy during a 15-month follow-up period, according to the duration of the sublingual immunotherapy.
• Outcomes:
  Evolution of patient feeling in relation to his allergy during a 15-month follow-up period. Symptom evolution (questionnaires ARIA, T5SS, GINA), sleep evolution (questionnaire Epworth), NPPs compliance, quality of life evolution, evolution of healthcare use in relation to allergy during a 15 months follow-up period.
• Data analysis plan:
  Statistical analyses will be carried out by the Bordeaux PharmacoEpi platform. Analyses will be conducted separately for children and teenagers/adults and performed according to the sublingual immunotherapy duration:- A flow chart depicting the number of patients enrolled and followed,- Description of patients and comparison of their characteristics according to the sublingual immunotherapy duration,- Assessment of treatment impact score during the follow-up,- Proportion of patients with a treatment benefit,- Description of symptoms at inclusion and evolution during the follow-up, for allergic rhinitis and asthma, - Sleep, quality of life and NPPs compliance evolution during follow-up,- Description of the 15-month healthcare resources use (SNDS data),- Assessment of disease score with SNDS data during historic period.Two last analyses will be performed according to the procedure defined by the French law, provided that additional funding are granted.