Investigating the role of estrogen in lung disease

invEstigating oeStrogen Signalling and the Effect upoN the exTracelluar Matrix In pAtients With Obstructive Lung Disease

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
• Enrollment: 100 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Guy's and St Thomas' NHS Foundation Trust (Academic / other)
• Locations: 1 site (London)
• Trial ID: NCT06713512 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

London

• 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

Conditions Chronic Obstructive Lung Disease; Respiratory Ilness; Estrogen Deficiency; Asthma; COPD