Acid-suppressing Drugs Pregnancy Asthma Offspring Study

Asthma in Offspring Clinical Trial

Official title:

A Cohort Study on the Association Between Acid-suppressing Drugs in Pregnancy and Asthma in the Offspring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787435
• Other study ID #: D9612N00018
• Status: Completed
• Phase: N/A
• First received: February 6, 2013
• Last updated: April 3, 2015
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this study is

1. To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood.

2. To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.

Description:

A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10116
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Females aged 18-45 years with at least one pregnancy between 1 January 1995 - 31 December 2010 (see study population description)

Exclusion Criteria:

• Males, females below age 18 and 45 years and above (see study population description)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma
• Asthma in Offspring

Intervention

Drug:
• Risk of asthma in offspring
Exposure to PPI or H2RA, respectively during pregnancy No exposure to acid suppressing drugs during pregnancy

Locations

Country	Name	City	State
Spain	Research Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitors		From 1 January 2005 till 31 December 2010, an expected average of 5 years.	Yes
Primary	Relative risk of first asthma diagnosis associated with prenatal exposure to histamine-2 receptor antagonists		From 1 January 2005 till 31 December 2010, an expected average of 5 years	Yes