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NCT Number: NCT06713512

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guys & St Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location status: Recruiting

Location contact

Christine Mwasuku, MSc

CONTACT

[email protected]

+442071888070

Christine Mwasuku, MSc

SUB_INVESTIGATOR

Gillian Radcliffe, MRES

CONTACT

[email protected]

+442071888070

Mona Bafadhel, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Pregnant
  • 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).

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  1. 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

  1. Oscillometry

    Time frame: Through study completion, minimum of 1 year

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

  2. The COPD Assessment Test (CAT)

    Time frame: Through study completion, minimum of 1 year

    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

  3. Asthma Control Questionnaire (ACQ)

    Time frame: Through study completion, minimum of 1 year

    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.

  4. Asthma Quality of Life Questionnaire (AQLQ)

    Time frame: Through study completion, minimum of 1 year

    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.

  5. EQ-5D-5L

    Time frame: Through study completion, minimum of 1 year

    The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

  6. The Greene Climacteric Scale (GCS)

    Time frame: Through study completion, minimum of 1 year

    is a questionnaire that helps to determine the severity of menopausal symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Chris Mwasuku

CONTACT

[email protected]

Gill Radcliffe Ms, MRes

CONTACT

[email protected]

+442071888070

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Acronym: ESSENTIAL

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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