An observational study of ORALAIR® (Grass pollen allergen extract from: Cocksfoot, Sweet Vernal, Rye Grass, Meadow Grass, Timothy) tablet for sublingual use in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis (SL74.14)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/24770
• EU PAS number:
  EUPAS8104
• Study ID:
  24770
• Official title and acronym:
  An observational study of ORALAIR® (Grass pollen allergen extract from: Cocksfoot, Sweet Vernal, Rye Grass, Meadow Grass, Timothy) tablet for sublingual use in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis (SL74.14)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany
• Study description:
  Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days of treatment
• Study status:
  Finalised

Research institutions and networks

Institutions

Stallergenes

NA,retrospective database analysis

Multiple centres: 103 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 29/10/2014

Actual: 29/10/2014

Study start date

Planned: 01/12/2014

Actual: 19/01/2015

Data analysis start date

Planned: 01/09/2017

Actual: 03/07/2017

Date of final study report

Planned: 31/12/2017

Actual: 15/12/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Stallergenes SAS

Regulatory

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