invEstigating oeStrogen Signalling and the Effect upoN the exTracelluar Matrix In pAtients With Obstructive Lung Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Lung Disease
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Lung Function (FEV1 change from baseline)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
- •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).
Outcomes
Primary Outcomes
Lung Function (FEV1 change from baseline)
Time Frame: Through study completion, minimum of 1 year
Lung function measures the volume of air exhaled at specific time points during complete exhalation by force, which is preceded by a maximal inhalation.
Secondary Outcomes
- Oscillometry(Through study completion, minimum of 1 year)
- The COPD Assessment Test (CAT)(Through study completion, minimum of 1 year)
- Asthma Control Questionnaire (ACQ)(Through study completion, minimum of 1 year)
- Asthma Quality of Life Questionnaire (AQLQ)(Through study completion, minimum of 1 year)
- EQ-5D-5L(Through study completion, minimum of 1 year)
- The Greene Climacteric Scale (GCS)(Through study completion, minimum of 1 year)