Status: Ongoing
First registered on:
28/08/2020
Last updated on:
03/05/2021
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
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
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 collection01/09/202001/09/2020
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)
6. Study drug(s) information
Single-Constituent (Substance INN)ALLERGEN EXTRACT
7. Medical conditions to be studied
Medical condition(s)Yes
Allergic respiratory disease
8. Population under study
Age
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects80000
Additional information
30 000 children and 50 000 teenagers/adults
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
SNDS National claims database, France
Sources of data
Prospective patient-based data collection
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
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.
Are there primary outcomes?Yes
Evolution of patient feeling in relation to his allergy during a 15-month follow-up period.
Are there secondary outcomes?Yes
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.
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Patients will be followed-up during a 15-month period.
15. Data analysis plan
Please provide a brief summary of the analysis method
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.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
