WEUSRTP4850: Phase II: ICS/LABA Use in Pregnancy and Outcomes

CompletedOBSERVATIONAL
Enrollment

1

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

August 31, 2013

Study Completion Date

August 31, 2013

Conditions
Asthma
Interventions
DRUG

Fluticasone propionate (with and without concurrent salmeterol)

"Fluticasone propionate is an inhaled corticosteroid used for the treatment of asthma, often in combination with the long-acting β-agonist salmeterol. For the primary endpoint, exposure status will be determined based on the individual receiving a prescription for the drug of interest (fluticasone propionate or another inhaled corticosteroid) in the 2 weeks immediately before the LMP date or during the first trimester of pregnancy.~Sensitivity analysis will be carried out categorising exposure based on mapping the duration of prescriptions based on the number of inhalers, number of puffs within an inhaler and the prescribed daily dose."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY