The Essential study
Research type
Research Study
Full title
Investigating oestrogen signaling and the effect upon the extracellular matrix in patients with obstructive lung disease
IRAS ID
326236
Contact name
Mona Bafadhel
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 7 months, 31 days
Research summary
We are investigating the effect of oestrogen and oestrogen loss on the lungs. This is important to because lung diseases are a growing problem globally. In people suffering from Asthma and chronic obstructive pulmonary disease (COPD) (which are lung diseases) are more likely to die from lung disease than men. We believe this global difference is due to sex hormones. Women have more oestrogen than men. Other studies have shown that oestrogen affects the lungs through the immune system. We want to know the effect that oestrogen has on the lungs in people suffering from Asthma and COPD by comparing this to people with no lung disease. We are also particularly interested in what happens at the point where women lose their oestrogen naturally, which is the menopause. We want to understand the effect of oestrogen in younger women and compare this to women who have experienced the menopause.
This is an observational study. Therefore, the participant will have a baseline visit and another subsequent visit (or multiple visits which are optional) and we will compare the changes in their oestrogen levels, lung function and immune system response. To understand the differences mentioned above in the body we require samples and questionnaires to be filled out at face-to-face visits.
We will be recruiting participants from Guy’s and St Thomas’ NHS Foundation Trust, Asthma and COPD clinics. The study will last for 3.5 years. Each participant who signs up will be required to participate for a minimum of 12 months and have two visits. This is because we will need to compare individual results from their first visit to the next visit to come up with meaningful results of the oestrogen changes that have occurred during that time and how their lungs have been affected. All participants will be given the opportunity to opt into different streams of visits which vary between 12 months and 24 months.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
24/LO/0161
Date of REC Opinion
27 Jun 2024
REC opinion
Further Information Favourable Opinion