RecruitingOBSERVATIONAL

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

This study investigates the role of oestrogen, a female hormone, in lung conditions such as asthma and Chronic Obstructive Pulmonary Disease (COPD). Researchers want to understand how oestrogen levels might impact lung health, particularly in women, and why these diseases can affect women more severely. They're comparing people with and without these conditions, including women going through menopause, to see how oestrogen changes affect lung function and structure. The study is observational, meaning participants won't receive any new treatments, but will be monitored over time through visits and samples. The aim is to gather important information without any direct intervention.

At a glance

Status

Recruiting

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

100

Start

01 Dec 2024

Estimated completion

01 Nov 2028

Chronic Obstructive Lung Disease Respiratory Ilness Estrogen Deficiency Asthma

What is this study about?

This research wants to understand how a female hormone called oestrogen might be connected to lung problems like asthma and Chronic Obstructive Pulmonary Disease (COPD). Lung diseases are becoming more common around the world, and we know that women are sadly more likely to die from lung conditions than men. Researchers think this difference might be linked to hormones like oestrogen, which women naturally have more of.

Previous studies have hinted that oestrogen can affect the lungs, especially through the body's immune system. This study aims to dig deeper into this connection. They want to compare people with asthma or COPD to healthy individuals to see if oestrogen levels behave differently and what impact this might have on lung function and how the lungs are built. They are particularly interested in what happens during menopause, when a woman's oestrogen levels naturally drop. By looking at younger women compared to women who have gone through menopause, they hope to get a clearer picture of oestrogen's influence across different life stages.

It's important to remember this is an 'observational' study. This means you won't be given any new medication or treatment. Instead, the researchers will be carefully watching and collecting information over time to see how things naturally unfold. They want to find out if changes in oestrogen contribute to quicker decline in lung function or changes in lung structure, and if this is linked to inflammation, the immune system, or changes in important lung tissues like elastin and collagen.

Key takeaways

Investigating how oestrogen affects asthma and COPD.
Compares people with and without lung conditions.
Particularly interested in women, including those in menopause.
It's an 'observational' study, no new treatments.
Involves visits, samples, and questionnaires.
Aims to improve future understanding and care for lung diseases.

Who may be eligible?

This study is looking for both men and women aged 18 and over. For women specifically, you can take part whether you are still having periods (pre-menopausal), experiencing changes before menopause (peri-menopausal), or have already gone through menopause (post-menopausal).

If you don’t have asthma or COPD, you might be eligible as a healthy volunteer, as long as you haven't smoked much in your life (less than 10 pack years).

However, there are certain reasons why you wouldn't be able to join. For example, if you have certain infections like HIV or hepatitis, or if you have a history of serious mental health conditions, or if you are pregnant. Also, if you have a history of active cancer, are using long-term oxygen, or have other serious long-term health conditions that significantly shorten your life expectancy, you wouldn't be able to participate. It's also vital that you can understand and agree to take part in the study in writing.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Can you provide written consent to take part?
Do you have asthma or COPD, or are you a healthy non-smoker?
Are you a woman who is pre-menopausal, peri-menopausal, or post-menopausal?
Do you have a general good health, without serious illnesses like active cancer or chronic infections (e.g., HIV, Hepatitis)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, this study is completely observational, meaning you won't be given any new treatments or medications. Your involvement will typically include a first visit to the research clinic. You'll then have the option of having further visits with the research team over a period that could be between 12 and 24 months. During these visits, the researchers will collect samples, such as blood or urine, to measure your oestrogen levels, lung function, and how your immune system is working. You'll also be asked to complete some questionnaires. The study's duration varies depending on which stream of visits you opt into, but it will involve attending face-to-face appointments.

Potential risks and benefits

As this is an observational study, there are no medical interventions, so the direct medical risks are generally very low. Any procedures, like giving blood samples, carry minor, temporary discomforts such as a small bruise. The benefit to you directly might include gaining a better understanding of your own health information through the assessments conducted. More generally, your participation will greatly help our understanding of lung diseases and how they affect women, potentially leading to better care in the future. You are free to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Guys & St Thomas NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is an 'observational' study?

An observational study means researchers watch and collect information without giving any new treatments or asking you to change your current care. They just observe what happens naturally.

Why is oestrogen important for this study?

Researchers believe oestrogen, a female hormone, might play a role in how lung diseases like asthma and COPD develop and progress, particularly in women.

Will I have to take any new medicines?

No, this study does not involve giving you any new medicines or treatments. It's purely about observing and collecting information.

How long will I need to be involved?

Your involvement could range from 12 to 24 months, depending on which follow-up visit schedule you choose to opt into.

What kind of tests will I have?

You'll have some samples taken, like blood, and your lung function will be checked. You'll also fill out questionnaires, all during face-to-face visits.

How to find out more

Gill Radcliffe Ms, MRes

gillian.radcliffe@gstt.nhs.uk +442071888070 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.