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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (1 UK site)
Guys & St Thomas NHS Foundation Trust
London SE1 7EH, United Kingdom
How to Get in Touch
Gill Radcliffe Ms, MRes
Sponsor contactCONTACT
Chris Mwasuku
Sponsor contactCONTACT
