Study identification

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 institutions and networks

Institutions

Contact details

ERIC VAN GANSE

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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