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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorGuy's and St Thomas' NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No Intervention

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: People with physician-diagnosed disease (Asthma and/or COPD).1 intervention
Group B: Healthy controls1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, minimum of 1 year

Secondary outcomes

1

Oscillometry

Oscillometry is a technique that measures the mechanical impedance of the respiratory system, or how well the lungs are functioning.

Time frame
Through study completion, minimum of 1 year
2

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

Time frame
Through study completion, minimum of 1 year
3

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.

Time frame
Through study completion, minimum of 1 year
4

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.

Time frame
Through study completion, minimum of 1 year

Other outcomes

Sponsors and contacts

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