Clinical trial NCT06713512: InvEstigating oeStrogen Signalling and the Effect upoN the exTracelluar Matrix In pAtients With Obstructive Lung Disease
Official title: invEstigating oeStrogen Signalling and the Effect upoN the exTracelluar Matrix In pAtients With Obstructive Lung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Lung Disease
Respiratory Ilness
Estrogen Deficiency
Asthma
Keywords: Asthma
COPD
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with physician-diagnosed disease (Asthma and/or COPD) or healthy controls

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Men and women aged \&gt; 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 \&lt;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 \&lt; 3 years.
7. Patients with a history of active cancer.
8. Patients on long term oxygen (ambulatory oxygen).

Primary outcomes:
measure: Lung Function (FEV1 change from baseline)
timeFrame: Through study completion, minimum of 1 year
Secondary outcomes:
measure: Oscillometry
timeFrame: Through study completion, minimum of 1 year
measure: The COPD Assessment Test (CAT)
timeFrame: Through study completion, minimum of 1 year
measure: Asthma Control Questionnaire (ACQ)
timeFrame: Through study completion, minimum of 1 year
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Through study completion, minimum of 1 year
measure: EQ-5D-5L
timeFrame: Through study completion, minimum of 1 year
measure: The Greene Climacteric Scale (GCS)
timeFrame: Through study completion, minimum of 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guys & St Thomas NHS Foundation Trust
Study officials:
affiliation: King's College London
name: Mona Bafadhel
role: PRINCIPAL_INVESTIGATOR
References: