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

Last updated: November 27, 2024
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Bronchitis

Chronic Obstructive Pulmonary Disease (Copd)

Copd (Chronic Obstructive Pulmonary Disease)

Treatment

No intervention

Clinical Study ID

NCT06713512
326236
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men and women aged > 18 years.

  2. For female participants: pre-menopausal, peri-menopausal and post-menopausal womencan all be included.

  3. Participants willing and able to give informed consent for participation in thestudy.

  4. Healthy controls <10 pack year history (participants without Asthma or COPD).

Exclusion

Exclusion Criteria:

  1. Known or suspected current pulmonary tuberculosis, HIV (human immunodeficiencyvirus), Hepatitis B Virus, Hepatitis C Virus.

  2. Alcohol or recreational drug abuse, is defined as when the use is harmful as per NHSdefinition.

  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).

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
December 01, 2024
Estimated Completion Date:
November 01, 2028

Study Description

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.

Connect with a study center

  • Guys & St Thomas NHS Foundation Trust

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

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