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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with physician-diagnosed disease (Asthma and/or COPD). | People with physician-diagnosed disease (Asthma and/or COPD). |
| |
| Healthy controls | People with no physician-diagnosed disease (Asthma and/or COPD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lung Function (FEV1 change from baseline) | Lung function measures the volume of air exhaled at specific time points during complete exhalation by force, which is preceded by a maximal inhalation. | Through study completion, minimum of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Oscillometry | Oscillometry is a technique that measures the mechanical impedance of the respiratory system, or how well the lungs are functioning. | Through study completion, minimum of 1 year |
| The COPD Assessment Test (CAT) |
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Inclusion Criteria:
Exclusion Criteria:
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People with physician-diagnosed disease (Asthma and/or COPD) or healthy controls
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gill Radcliffe Ms, MRes | Contact | +442071888070 | gillian.radcliffe@gstt.nhs.uk | |
| Chris Mwasuku | Contact | Christine.Mwasuku@gstt.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Mona Bafadhel | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guys & St Thomas NHS Foundation Trust | Recruiting | London | SE1 7EH | United Kingdom |
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The COPD Assessment Test (CAT) is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD). It is designed to measure the impact of COPD on a person's life, and how this changes over time
| Through study completion, minimum of 1 year |
| Asthma Control Questionnaire (ACQ) | A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. | Through study completion, minimum of 1 year |
| Asthma Quality of Life Questionnaire (AQLQ) | A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease. The instrument should not be confused with the measure developed by Marks GB and colleagues, which carries the same name. | Through study completion, minimum of 1 year |
| EQ-5D-5L | The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). | Through study completion, minimum of 1 year |
| The Greene Climacteric Scale (GCS) | is a questionnaire that helps to determine the severity of menopausal symptoms. | Through study completion, minimum of 1 year |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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