Status: Finalised First registered on: 13/05/2015
Last updated on: 24/11/2022
1. Study identification
EU PAS Register NumberEUPAS9358
Official titleAssessment of Oralair® use in real-life
Study title acronymEVORA
Study typeObservational study
Brief description of the studyOralair® is a sublingual immunotherapy tablet indicated for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis with relevant clinical symptoms confirmed by positive skin test and or existence of pollen specific IgE antibodies for any of the five grass species contained in this drug. Oralair® is approved for use in children (older than 5 years of age) and adults. The EVORA study was requested by the French authorities to assess the use of Oralair® in real-life in France. This study is a prospective cohort of 300 adults and 150 children who initiate Oralair® for the next pollen season with a follow-up until the end of the season and is conducted by allergy specialists.
Was this study requested by a regulator?Yes: France
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
Not applicable (single centre)

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 signed20/12/2013
Start date of data collection01/12/201401/12/2014
Start date of data analysis
Date of interim report, if expected
Date of final study report30/04/201623/06/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesStallergenes SA100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Blin
First name Patrick
Address line 1146 Rue Leo Saignat
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code) 
Email address patrick.blin@u-bordeaux.fr
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1146 Rue Leo Saignat 
Address line 2 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code) 
Email address patrick.blin@u-bordeaux.fr 
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