Status: Finalised First registered on: 30/05/2012
Last updated on: 13/05/2015
1. Study identification
EU PAS Register NumberEUPAS2628
Official titleAsthma treatment in pregnancy and the frequency of adverse pregnancy outcomes (WEUSRTP4850)
Study title acronym
Study typeObservational study
Brief description of the studyFluticasone propionate (FP) is an inhaled corticosteroid (ICS) used for the treatment of asthma, often in combination with the long-acting β-agonist salmeterol. Owing to small numbers of pregnancy exposures in the past, little is known about the safety of FP when used during pregnancy. Now, however, there are sufficient 1st trimester exposed pregnancies on the General Practice Research Database to allow the overall risk of major congenital malformations (MCMs) following exposure to FP to be evaluated. This study aims to evaluate the safety profile of FP compared with exposure to all other ICS with all MCMs combined as the primary endpoint whilst taking into account potential confounders and exposure to other asthma medicines. Analyses will be carried out separately for FP alone and FP in combination. If appropriate the two groups will be combined. In order to give an overall picture of the risks of adverse pregnancy outcomes associated with asthma in general and different levels of asthma control, irrespective of the products used for treatment, this study will also evaluate - 1. The risk of MCMs in pregnancies to women with ‘considerable to severe’ and ‘moderate’ asthma activity during the 1st trimester of pregnancy compared with those with ‘mild’ asthma activity during the 1st trimester. 2. The prevalence of specific MCMs identified within the entire asthma population. 3. The risk of a spontaneous pregnancy loss to women with ‘considerable to severe’ and ‘moderate’ asthma activity during the 1st trimester of pregnancy compared with those with ‘mild’ asthma activity during the 1st trimester. 4. The risk of a pre-term delivery to women with ‘considerable to severe’ and ‘moderate’ asthma activity in the 3rd trimester of pregnancy compared with those with ‘mild’ asthma activity in the 3rd pregnancy trimester. 5. The analyses carried out for pre-term delivery will also be carried out to evaluate the risk of stillbirths and neonatal death.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUniversity of Bath
Department/Research groupPharmacy & Pharmacology
Organisation/affiliationUniversity of Bath
Website/Homepagewww.bath.ac.uk
Details of (Primary) lead investigator
Title Professor
Last name de Vries
First name Corinne
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

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/06/201201/06/2012
Start date of data collection23/07/201201/08/2012
Start date of data analysis
Date of interim report, if expected
Date of final study report28/02/201331/07/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesGlaxoSmithKline100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Charlton
First name Rachel
Address line 1Dept. of Pharmacy & Pharmacology
Address line 2University of Bath 
Address line 3Claverton Down 
CityBath 
PostcodeBA2 7AY 
CountryUnited Kingdom
Phone number (incl. country code)44-1225-383672 
Alternative phone number 
Fax number (incl. country code)44-1225-386114 
Email address r.a.charlton@bath.ac.uk
Public Enquiries
Title Dr 
Last name Charlton 
First name Rachel 
Address line 1Dept. of Pharmacy & Pharmacology 
Address line 2University of Bath 
Address line 3Claverton Down 
CityBath 
PostcodeBA2 7AY 
CountryUnited Kingdom 
Phone number (incl. country code)44-1225-383672 
Alternative phone number 
Fax number (incl. country code)44-1225-386114 
Email address r.a.charlton@bath.ac.uk 
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