A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring (Acid-suppressing Drugs Pregnancy Asthma Offspring)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/18591
• EU PAS number:
  EUPAS17960
• Study ID:
  18591
• Official title and acronym:
  A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring (Acid-suppressing Drugs Pregnancy Asthma Offspring)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  In this observational cohort study (NCT01787435), women aged 18 to 45 years with completed pregnancies between January 1996 and December 2010 were identified from The Health Improvement Network, and were linked to infants. The relative risk of asthma in children who experienced prenatal exposure to PPIs and/or H2RAs were quantified, adjusting for potential confounders. Hazard ratios (HRs) were estimated using Cox proportional hazard models.
• Study status:
  Finalised

Research institution and networks

Institutions

Fundación Centro Español de Investigación Farmacoepidemiológica (CEIFE)

Spain

Study timelines

Date when funding contract was signed

Actual: 13/12/2011

Study start date

Actual: 15/06/2013

Data analysis start date

Actual: 15/06/2014

Date of final study report

Actual: 15/12/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

D9612N00018_Redacted_protocol

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

D9612N00018