About this trial
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
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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
Trial population
People with physician-diagnosed disease (Asthma and/or COPD) or healthy controls
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention
Other interventionNo Intervention
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Oscillometry
Oscillometry is a technique that measures the mechanical impedance of the respiratory system, or how well the lungs are functioning.
The COPD Assessment Test (CAT)
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
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.
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.
Sponsors and contacts
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