Assessment of Oralair® use in real-life (EVORA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49935
• EU PAS number:
  EUPAS9358
• Study ID:
  49935
• Official title and acronym:
  Assessment of Oralair® use in real-life (EVORA)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Oralair® 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.
• Study status:
  Finalised

Research institution and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual: 20/12/2013

Study start date

Planned: 01/12/2014

Actual: 01/12/2014

Date of final study report

Planned: 30/04/2016

Actual: 23/06/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Stallergenes SA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable