Asthma treatment in pregnancy and the frequency of adverse pregnancy outcomes (WEUSRTP4850)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/9739
• EU PAS number:
  EUPAS2628
• Study ID:
  9739
• Official title and acronym:
  Asthma treatment in pregnancy and the frequency of adverse pregnancy outcomes (WEUSRTP4850)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Fluticasone 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.
• Study status:
  Finalised

Research institution and networks

Institutions

University of Bath

Study timelines

Date when funding contract was signed

Planned: 01/06/2012

Actual: 01/06/2012

Study start date

Planned: 23/07/2012

Actual: 01/08/2012

Date of final study report

Planned: 28/02/2013

Actual: 31/07/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

Asthma in Pregnancy_University of Bath_ENCePP_July2012

Regulatory

• Was the study required by a regulatory body?:
  No