Exogenous sex steroid hormones and asthma in females: a population-based retrospective cohort study using primary care data

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/22968
• EU PAS number:
  EUPAS22967
• Study ID:
  22968
• Official title and acronym:
  Exogenous sex steroid hormones and asthma in females: a population-based retrospective cohort study using primary care data
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Introduction:Female sex steroid hormones have been implicated in sex-related differences in the development and clinical outcomes of asthma. The role of exogenous sex steroids however remains unclear. We aim to investigate whether the use of hormonal contraception and hormone replacement therapy (HRT), subtypes, and route of administration are associated with asthma onset and clinical outcomes in reproductive age and peri-menopausal/post-menopausal females. Methods and analysis: Using the Optimum Patient Care Research Database (OPCRD), a national primary care database in the UK, we will construct a retrospective longitudinal cohort of reproductive age (16-45 years) and peri-menopausal/post-menopausal (46+ 70years) females. We will estimate the risk of new-onset asthma using Cox regression and multilevel modelling for repeated asthma outcomes, such as asthma attacks. We will adjust for confounding factors in all analyses. We will evaluate interactions between the use of exogenous sex hormones and body mass index and smoking by calculating the relative excess risk due to interaction and the attributable proportion due to interaction. With 90% power, we need 23,700 reproductive age females to detect a 20% reduction (risk ratio 0.8) in asthma attacks for use of any hormonal contraception and 6,000 peri-menopausal/post-menopausal females to detect a 40% (risk ratio 1.40) increased risk of asthma attacks for use of any HRT. Conclusions: This study aims to overcome the limitations of previous studies, thereby providing the most robust evidence to help gain better insights into the effect of sex steroid hormones in the pathogenesis and clinical outcomes of asthma in females. We will present our findings at national and international scientific meetings and
• Study status:
  Ongoing

Research institution and networks

Institutions

University of Edinburgh

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 02/01/2017

Study start date

Actual: 02/10/2017

Date of final study report

Planned: 31/12/2018

Sources of funding

Non for-profit organisation (e.g. charity)

More details on funding

Asthma UK

Study protocol

Initial protocol

Exogenous Sex Hormones and Asthma in Females OPCRD Protocol

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable