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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Chronic Obstructive Lung Disease; Estrogen Deficiency; Respiratory Ilness
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Gill Radcliffe Ms, MRes; Phone Number: +442071888070; Email: gillian.radcliffe@gstt.nhs.uk
• Study Contact Backup: Name: Chris Mwasuku; Email: Christine.Mwasuku@gstt.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Guys & St Thomas NHS Foundation Trust
    • Contact: Gillian Radcliffe, MRES; Phone Number: +442071888070; Email: gillian.radcliffe@gstt.nhs.uk
    • Contact: Christine Mwasuku, MSc; Phone Number: +442071888070; Email: christine.mwasuku@kcl.ac.uk
    • Principal Investigator: Mona Bafadhel, PhD
    • Sub-Investigator: Christine Mwasuku, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

People with physician-diagnosed disease (Asthma and/or COPD) or healthy controls

Description

Inclusion Criteria:

1. Men and women aged > 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 <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 < 3 years.
7. Patients with a history of active cancer.
8. Patients on long term oxygen (ambulatory oxygen).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
People with physician-diagnosed disease (Asthma and/or COPD).	Other: No intervention; No Intervention
Healthy controls; People with no physician-diagnosed disease (Asthma and/or COPD).	Other: No intervention; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Mona Bafadhel, King's College London

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Asthma; COPD
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 326236

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No