Status: Finalised First registered on: 23/02/2017
Last updated on: 11/04/2017
1. Study identification
EU PAS Register NumberEUPAS17960
Official titleA cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring
Study title acronymAcid-suppressing Drugs Pregnancy Asthma Offspring
Study typeObservational study
Brief description of the studyIn 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.
Was this study requested by a regulator?Yes: United Kingdom
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableD9612N00018
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCEIFE
Department/Research groupFundación Centro Español de Investigación Farmacoepidemiológica
Organisation/affiliationFundación CEIFE
Website/Homepagewww.ceife.es
Details of (Primary) lead investigator
Title Dr
Last name García Rodríguez
First name Luis Alberto
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed13/12/2011
Start date of data collection15/06/2013
Start date of data analysis15/06/2014
Date of interim report, if expected
Date of final study report15/12/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name García Rodríguez
First name Luis Alberto
Address line 11800 Concord Pike
Address line 2PO Box 15437 
Address line 3 
CityWilmington, De 
Postcode19850 
CountryUnited States
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Email address information.center@astrazeneca.com
Public Enquiries
Title Dr 
Last name AstraZeneca 
First name Clinical Study Information Center 
Address line 11800 Concord Pike 
Address line 2PO Box 15437 
Address line 3Wilmington, De 
CityMadrid 
Postcode19850 
CountryUnited States 
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Email address information.center@astrazeneca.com 
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