Status: Planned First registered on: 28/08/2020
Last updated on: 10/09/2020
1. Study identification
EU PAS Register NumberEUPAS36947
Official titleStudy on feeling according to the patient of allergens specially prepared for individuals (allergenic ‘Named Patient Products’ NPPs)
Study title acronymERAPP
Study typeObservational study
Brief description of the studyIn 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name Blin
First name Patrick
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2
Société Française d'Allergologie, France
Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed10/12/2019
Start date of data collection01/09/2020
Start date of data analysis01/10/2021
Date of interim report, if expected30/06/2023
Date of final study report30/06/2024
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesALK; Stallergenes Greer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name BOSCO-LEVY
First name Pauline
Address line 1University of Bordeaux
Address line 2146, Rue Léo Saignat 
Address line 3Bâtiment du Tondu - Case 41 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name BOSCO-LEVY 
First name Pauline 
Address line 1University of Bordeaux 
Address line 2146, Rue Léo Saignat 
Address line 3Bâtiment du Tondu - Case 41 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code) 
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