Observational study to quantify in real life the contribution of SINGULAIR ® 4mg in children aged from 6 to 24 months (NA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19575
• EU PAS number:
  EUPAS13721
• Study ID:
  19575
• Official title and acronym:
  Observational study to quantify in real life the contribution of SINGULAIR ® 4mg in children aged from 6 to 24 months (NA)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  SINGULAIR® 4mg is an additive treatment to inhaled corticosteroids in 6 month to 5 year children with mild to moderate persistent asthma, inadequately controlled by inhaled corticosteroids and in whom immediate and short-term beta 2 agonists, administered at the request, does not provide sufficient clinical asthma control. The French Economic Committee for Health Products (CEPS) asked MSD France laboratory "to establish an epidemiological study of children under 2 years old, with the primary objective to determine whether the introduction of SINGULAIR® in the therapeutic arsenal provides better control of mild to moderate persistent asthma, poorly controlled when real prescribing practice is in relation to existing recommendations".Based on the French national health insurance database (SNII-RAM) which contains healthcare reimbursement data of the French population, the objective of this study is to compare the support, following an exacerbation, of children aged from 6 to 24 months with persistent asthma, between the addition of SINGULAIR® 4mg and a reinforcement of inhaled corticosteroids, according to existing guidelines.
• Study status:
  Finalised

Research institution and networks

Institutions

PharmacoEpidemiology Unit (PELyon), Claude Bernard Lyon 1 University

France

Study timelines

Date when funding contract was signed

Planned: 03/10/2011

Actual: 03/10/2011

Study start date

Planned: 21/12/2012

Actual: 21/12/2012

Data analysis start date

Planned: 02/05/2013

Actual: 02/05/2013

Date of final study report

Planned: 30/09/2013

Actual: 30/09/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MSD France

Regulatory

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