Asthma in OffspringNCT01787435
Acid-suppressing Drugs Pregnancy Asthma Offspring Study
An observational study of Asthma in Offspring, run by AstraZeneca at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Asthma in Offspring
- What is being tested?
- Risk of asthma in offspring
- How many people
- 10,116 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All women aged 18-45 years and with at least one pregnancy between 1 January 1995 and 31 December 2010 who have been enrolled with their PCP (Primary Care Physician) for at least 1 year and have had a health contact in the year prior to the last menstrual period (LMP) of the respective pregnancy. The final study population will include pregnancies that can be unequivocally linked with live birth(s) and only the first pregnancy ascertained during the study period for each woman will be retained
Who may be able to join
- Females aged 18-45 years with at least one pregnancy between 1 January 1995 - 31 December 2010 (see study population description)
Who cannot join
- Males, females below age 18 and 45 years and above (see study population description)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cohort Study on the Association Between Acid-suppressing Drugs in Pregnancy and Asthma in the Offspring
The purpose of this study is
- To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood.
- To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.
Read the detailed description
A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring
- Conditions
- Asthma in Offspring
- Being tested
- Risk of asthma in offspring
- Keywords
- Asthma,, acid-suppressing drugs,, pregnancy,, epidemiology
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk of asthma in offspringDrug
Exposure to PPI or H2RA, respectively during pregnancy
No exposure to acid suppressing drugs during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| All women exposed to PPI at any time during pregnancy | Exposure to PPI defined as presence of at least one prescription of a PPI any time between last menstrual period and delievry date Receives: Drug: Risk of asthma in offspring | |
| All women exposed to H2RA at any time during pregnancy | Exposure to H2RA defined as presence of at least one prescription of H2RA any time between last menstrual period and delivery date Receives: Drug: Risk of asthma in offspring | |
| Pregnant women with no recorded use of acid suppressing drugs | Pregnant women with no recorded use of acid suppressing drugs at any time during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitors
Measured: From 1 January 2005 till 31 December 2010, an expected average of 5 years.
Relative risk of first asthma diagnosis associated with prenatal exposure to histamine-2 receptor antagonists
Measured: From 1 January 2005 till 31 December 2010, an expected average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in OffspringStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,116 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis A Garcia Rodriguez, MD, Principal investigator, CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787435
- Sponsor's protocol ID
- D9612N00018
- Status last verified
- Apr 2015
- First submitted
- 6 Feb 2013
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on the Association Between Acid-suppressing Drugs in Pregnancy and Asthma in the Offspring
- ClinicalTrials.gov ID
- NCT01787435
- Acronym / sponsor ID
- D9612N00018
- Conditions
- Asthma in Offspring
- Keywords
- Asthma,, acid-suppressing drugs,, pregnancy,, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,116 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is
- To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood.
- To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.
Detailed description
A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| All women exposed to PPI at any time during pregnancy | – | Drug: Risk of asthma in offspringExposure to PPI defined as presence of at least one prescription of a PPI any time between last menstrual period and delievry date |
| All women exposed to H2RA at any time during pregnancy | – | Drug: Risk of asthma in offspringExposure to H2RA defined as presence of at least one prescription of H2RA any time between last menstrual period and delivery date |
| Pregnant women with no recorded use of acid suppressing drugs | – | –Pregnant women with no recorded use of acid suppressing drugs at any time during pregnancy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women aged 18-45 years and with at least one pregnancy between 1 January 1995 and 31 December 2010 who have been enrolled with their PCP (Primary Care Physician) for at least 1 year and have had a health contact in the year prior to the last menstrual period (LMP) of the respective pregnancy. The final study population will include pregnancies that can be unequivocally linked with live birth(s) and only the first pregnancy ascertained during the study period for each woman will be retained
Key inclusion criteria (1 listed)
- Females aged 18-45 years with at least one pregnancy between 1 January 1995 - 31 December 2010 (see study population description)
Key exclusion criteria (1 listed)
- Males, females below age 18 and 45 years and above (see study population description)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk of asthma in offspringExposure to PPI or H2RA, respectively during pregnancy No exposure to acid suppressing drugs during pregnancy | Drug | All women exposed to H2RA at any time during pregnancy, All women exposed to PPI at any time during pregnancy |
Primary outcome
Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitors
Time frame: From 1 January 2005 till 31 December 2010, an expected average of 5 years.
Relative risk of first asthma diagnosis associated with prenatal exposure to histamine-2 receptor antagonists
Time frame: From 1 January 2005 till 31 December 2010, an expected average of 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis A Garcia Rodriguez, MD principal investigator
CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Offspring, run by AstraZeneca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitors (time frame: From 1 January 2005 till 31 December 2010, an expected average of 5 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015.