Actively Recruiting
Investigating Oestrogen Signalling and Its Effect on the Extracellular Matrix in Patients With Obstructive Lung Disease
Led by Guy's and St Thomas' NHS Foundation Trust · Updated on 2024-12-03
100
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how oestrogen affects people with asthma and Chronic Obstructive Pulmonary Disease (COPD), compared to those without these conditions. The study focuses on understanding if losing oestrogen, especially in women going through menopause, leads to faster lung decline and changes in lung structure. They aim to learn if inflammation, immune response, or changes in lung proteins like elastin and collagen play a role in this process. This is an observational study involving healthy people and those diagnosed with asthma or COPD. Participants will have a baseline visit and may have additional optional visits over 12 to 24 months. During these visits, researchers will collect samples and have participants fill out questionnaires to track changes in oestrogen levels, lung function, and immune responses. Participants will undergo lung function tests including measuring FEV1, and complete assessments such as the COPD Assessment Test and various quality of life questionnaires over at least one year. The study includes face-to-face visits for sample collection and questionnaires. Researchers will monitor changes in lung health, oestrogen, and related immune factors throughout the study duration, which runs until November 2028.
CONDITIONS
Brief Title
InvEstigating oeStrogen Signalling and the Effect upoN the exTracelluar Matrix In pAtients With Obstructive Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged over 18 years
- Female participants can be pre-menopausal, peri-menopausal, or post-menopausal
- Participants must be willing and able to give informed consent
- Healthy controls must have less than 10 pack years smoking history and no asthma or COPD diagnosis
You will not qualify if you...
- Current or suspected pulmonary tuberculosis, HIV, Hepatitis B, or Hepatitis C infections
- Alcohol or recreational drug abuse as defined by NHS
- History of psychiatric, medical, or surgical disorders
- Pregnancy
- Unable to provide written informed consent
- Advanced medical conditions with life expectancy less than 3 years
- History of active cancer
- Use of long-term ambulatory oxygen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete baseline assessments including questionnaires, lung function tests, and sample collection to understand their current health status and hormone levels.
1 baseline visit (in-person)
Duration - 12 to 24 months
Participants are observed over 12 to 24 months with optional follow-up visits to monitor changes in oestrogen levels, lung function, and immune response.
At least 1 follow-up visit, with optional additional visits over the monitoring period
Trial Site Locations
Total: 1 location
1
Guys & St Thomas NHS Foundation Trust
London, United Kingdom, SE1 7EH
Actively Recruiting
Research Team
G
Gill Radcliffe Ms, MRes
C
Chris Mwasuku
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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