Study identification

EU PAS number

EUPAS36947

Study ID

40873

Official title and acronym

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

DARWIN EU® study

No

Study countries

France

Study description

In France, allergenic NPPs are named APSI for “Allergènes Préparés Spécialement pour un Individu” (allergens specially prepared for an individual). NPPs are indicated in allergen specific immunotherapy for respiratory tract disorders, allergic rhinitis and/or allergic asthma. This study is carried out as part of the evaluation of sublingual allergenic NPPs planned in 2023 by the French agency in charge of health technology assessment: the Haute Autorité de Santé (HAS). With this non-interventional study, real-world data will be gathered to evaluate the impact of a sublingual immunotherapy by NPPs during a 15-month follow-up period in terms of patient feeling, symptom evolution, sleep and quality of life. NPPs compliance as well as the patient healthcare use in relation to allergy will also be assessed. Analyzes will be performed separately for children and teenagers/adults, according to the sublingual immunotherapy duration. Linkage of data collected through a patient questionnaire to data from the French nationwide healthcare system database (SNDS database) could be performed with the patient agreement, according to the new procedure defined by the French law, provided that additional funding are granted.

Study status

Ongoing
Research institutions and networks

Institutions

Société Française d'Allergologie France

Contact details

Patrick Blin

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

ALK, Stallergenes Greer
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable