InvEstigating oeStrogen Signalling and the Effect upoN the exTracelluar Matrix In pAtients With Obstructive Lung Disease
Recruiting · NCT06713512 · Observational (researchers observe without assigning treatment) · Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 informed consent for participation in the study.
- Healthy controls \<10 pack year history (participants without Asthma or COPD).
Exclusion criteria
- Known or suspected current pulmonary tuberculosis, HIV (human immunodeficiency virus), Hepatitis B Virus, Hepatitis C Virus.
- 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 informed consent
- History of advanced medical conditions with an expected prognosis of \< 3 years.
- Patients with a history of active cancer.
- Patients on long term oxygen (ambulatory oxygen).
Where it is running
2 locations listed.
- Guys & St Thomas NHS Foundation Trust - London, United Kingdom
- Guys & St Thomas NHS Foundation Trust - London, United Kingdom