Investigating the role of estrogen in lung disease
Official title: invEstigating oeStrogen Signalling and the Effect upoN the exTracelluar Matrix In pAtients With Obstructive Lung Disease
Run by Guy's and St Thomas' NHS Foundation Trust · NCT06713512 · Data updated 2026-11-12
This study is testing how changes in estrogen levels affect lung health in women with asthma and COPD, especially during menopause, to see if lower estrogen makes their lung function worse.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | January 1, 2026 |
| Study ends | November 1, 2028 |
| Registry record updated | December 3, 2024 |
| Trial ID | NCT06713512 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men and women over 18 years, particularly pre-menopausal, peri-menopausal, and post-menopausal women, as well as healthy controls without lung disease.
✕Probably not a fit
Patients with known pulmonary tuberculosis, HIV, hepatitis, or those with a history of advanced medical conditions or active cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the impact of estrogen on lung function in patients with asthma and Chronic Obstructive Pulmonary Disease (COPD). It will compare estrogen levels and lung health between women at different stages of menopause and healthy controls. The study hypothesizes that estrogen loss contributes to accelerated lung function decline and structural changes in the lungs, potentially mediated by inflammation and immune responses. Participants will undergo baseline and follow-up visits to assess changes in estrogen levels, lung function, and immune system responses, with optional extended visits over 12 to 24 months.
Why it matters
Potential benefit: If successful, this study could provide insights into how estrogen affects lung health, potentially leading to improved treatments for women with asthma and COPD.
How similar studies have gone: While the role of estrogen in lung disease is being explored, this specific approach focusing on menopause and lung function in asthma and COPD is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Men and women aged \> 18 years. 2. For female participants: pre-menopausal, peri-menopausal and post-menopausal women can all be included. 3. Participants willing and able to give informed consent for participation in the study. 4. Healthy controls \<10 pack year history (participants without Asthma or COPD). Exclusion Criteria: 1. Known or suspected current pulmonary tuberculosis, HIV (human immunodeficiency virus), Hepatitis B Virus, Hepatitis C Virus. 2. Alcohol or recreational drug abuse, is defined as when the use is harmful as per NHS definition. 3. History of psychiatric, medical, or surgical disorders. 4. Pregnant 5. Unable to provide written informed consent 6. History of advanced medical conditions with an expected prognosis of \< 3 years. 7. Patients with a history of active cancer. 8. Patients on long term oxygen (ambulatory oxygen).
Where it's running
-
Guys & St Thomas NHS Foundation Trust
London, United Kingdom Recruiting
Study contacts
- Principal investigator: Mona Bafadhel — King's College London
- Study coordinator: Gill Radcliffe Ms, MRes
- Email: gillian.radcliffe@gstt.nhs.uk
- Phone: +442071888070
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.