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Contact Information:

Christine Mwasuku
Christine.mwasuku@kcl.ac.uk


Madeleine Peck
madeleine.peck2@nhs.net


Mona Bafadhel
mona.bafadhel@kcl.ac.uk


Gillian Radcliffe
gillier900@gmail.com


Gill Radcliffe
Gill.Radcliffe@nhs.net


Study Location:

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Be Part of Research - Trial Details - The Essential study

The Essential study

Recruiting

Open to: Female / Male

Age: 18 Years - 90 Years

Medical Conditions

Chronic lower respiratory diseases


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

16 Sep 2024 31 Dec 2026

Observational

Observational type: Clinical Laboratory Study;



You can take part if:



You may not be able to take part if:


Exclusion Criteria For Both Study Population & Healthy Controls: 1. Known or suspected current pulmonary tuberculosis, HIV (human immunodeficiency virus), Hepatitis B Virus, Hepatitis C Virus 2. Alcohol or recreational drug abuse 3. History of psychiatric, medical, or surgical disorders that in the opinion of the chief investigator may compromise sample collection, make the person unsuitable for bronchoscopy, negatively impact upon data collection and completion of the study, or any other reason that in the considered opinion of the investigator makes them an unsuitable candidate for the study. 4. Unable to provide written informed consent 5. Pregnant 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). Exclusion Criteria Specific To Healthy Controls: 1. Exclude if history of any respiratory disease. 2. Exclude if current smoker of cigarettes or recreational drugs, or currently vapes. 3. Exclude if ex-smoker and lifetime pack year history of > 10 years? 4. Exclude if history of any respiratory disease (e.g. asthma/COPD/ILD/bronchiectasis or cystic fibrosis/chronic respiratory infection/sleep disordered breathing/chronic ventilatory failure). Exclusion Criteria Specific To Study Population: 1. Exclude if history of any respiratory disease (e.g asthma/COPD/ILD/bronchiectasis or cystic fibrosis/chronic respiratory infection/sleep disordered breathing/chronic ventilatory failure).


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St Thomas' Hospital
    Westminster Bridge Road
    London
    Greater London
    SE1 7EH

Mona Bafadhel
mona.bafadhel@kcl.ac.uk


Christine Mwasuku
Christine.mwasuku@kcl.ac.uk


Madeleine Peck
madeleine.peck2@nhs.net


Gill Radcliffe
Gill.Radcliffe@nhs.net


Gillian Radcliffe
gillier900@gmail.com



The study is sponsored by King's College London and funded by Asthma and Lung UK .




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for Trial ID: CPMS 61348

Last updated 07 November 2025

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