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

Sponsor: Guy's and St Thomas' NHS Foundation Trust

NCT ID: NCT06713512

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
No intervention (other)
How long the study runs
Study runs about 47 months (dates as stated)
About the drug or intervention
No intervention — other: No Intervention
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years to 99 Years
Who
All
Number of participants
100
Started
2024-12-01
Last checked
2024-11

Plain English Summary

What is this study?

  • • Testing a new treatment for chronic obstructive lung disease
  • • Clinical study - 100 participants
  • • This study aims to understand the role of oestrogen in patients with asthma and Chronic Obstructive Pulmonary Disorder (COPD)

Who can take part?

  • • Ages 18 Years to 99 Years
  • • Diagnosed with chronic obstructive lung disease

Where?

  • • London - Guys & St Thomas NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This study aims to understand the role of oestrogen in patients with asthma and Chronic Obstructive Pulmonary Disorder (COPD). Therefore, what is the effect of oestrogen in these participants compared to controls (those without disease). The study hypothesises that oestrogen loss in patients with asthma and COPD causes accelerated lung function decline and changes to lung structure. It will investigate if this is mediated by inflammation, immune host response or elastin and collagen changes. It is an observational prospective cohort study aiming to recruit healthy controls, and people with asthma or COPD), and/or the menopause.

More detail

The investigators 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), women are more likely to die from lung disease than men. The researchers 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. The researchers 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. The researchers are also particularly interested in what happens at the point where women lose oestrogen naturally, which is the menopause. They 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 participants will have a baseline visit and another subsequent visit (or multiple visits which are optional) and the researchers 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. All participants will be given the opportunity to opt into different streams of visits which vary between 12 months and 24 months.

Chronic Obstructive Lung DiseaseRespiratory IlnessEstrogen DeficiencyAsthma

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 99 Years
  • Who can join: All genders

What the study is looking for

  • ✓Men and women aged \> 18 years.
  • ✓For female participants: pre-menopausal, peri-menopausal and post-menopausal women can all be included.
  • ✓Participants willing and able to give agreement to take part for participation in the study.
  • ✓Healthy controls \<10 pack year history (participants without Asthma or COPD).

Who cannot take part

  • ✗Known or suspected current lung tuberculosis, HIV (human immunodeficiency virus), Hepatitis B Virus, Hepatitis...
  • ✗Alcohol or recreational drug abuse, is defined as when the use is harmful as per NHS definition.
  • ✗History of psychiatric, medical, or surgical disorders.
  • ✗Pregnant
  • ✗Unable to provide written agreement to take part
See the full 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 Is This Study? (1 UK site)

Guys & St Thomas NHS Foundation Trust

London SE1 7EH, United Kingdom

Recruiting
Site contact (verified)
Mona Bafadhel, PhDPrincipal Investigator

How to Get in Touch

Gill Radcliffe Ms, MRes

Sponsor contact

CONTACT

+442071888070 gillian.radcliffe@gstt.nhs.uk

Chris Mwasuku

Sponsor contact

CONTACT

Christine.Mwasuku@gstt.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-11