Chronic Obstructive Lung DiseaseESSENTIALNCT06713512
InvEstigating oeStrogen Signalling and the Effect upoN the exTracelluar Matrix In pAtients With Obstructive Lung Disease
An observational study of Chronic Obstructive Lung Disease and Respiratory Ilness, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Lung Disease, Respiratory Ilness, Estrogen Deficiency
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2024to 1 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with physician-diagnosed disease (Asthma and/or COPD) or healthy controls
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chris Mwasuku contact
United Kingdom1 site, 1 recruiting
- Recruiting
Guys & St Thomas NHS Foundation Trust
London, SE1 7EH
Gillian Radcliffe, MRES, +442071888070, gillian.radcliffe@gstt.nhs.uk
Christine Mwasuku, MSc, +442071888070, christine.mwasuku@kcl.ac.uk
About this study
Official title: 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.
Read the 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.
- Being tested
- No intervention
- Keywords
- Asthma, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| People with physician-diagnosed disease (Asthma and/or COPD). | People with physician-diagnosed disease (Asthma and/or COPD). Receives: Other: No intervention | |
| Healthy controls | People with no physician-diagnosed disease (Asthma and/or COPD). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, minimum of 1 year
Secondary outcomes (6)
Oscillometry
Oscillometry is a technique that measures the mechanical impedance of the respiratory system, or how well the lungs are functioning.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Through study completion, minimum of 1 year
The Greene Climacteric Scale (GCS)
is a questionnaire that helps to determine the severity of menopausal symptoms.
Measured: Through study completion, minimum of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mona Bafadhel, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713512
- Sponsor's protocol ID
- 326236
- Acronym
- ESSENTIAL
- Status last verified
- Nov 2024
- First submitted
- 13 Sep 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- invEstigating oeStrogen Signalling and the Effect upoN the exTracelluar Matrix In pAtients With Obstructive Lung Disease
- ClinicalTrials.gov ID
- NCT06713512
- Acronym / sponsor ID
- ESSENTIAL / 326236
- Keywords
- Asthma, COPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with physician-diagnosed disease (Asthma and/or COPD). | – | Other: No interventionPeople with physician-diagnosed disease (Asthma and/or COPD). |
| Healthy controls | – | Other: No interventionPeople with no physician-diagnosed disease (Asthma and/or COPD). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with physician-diagnosed disease (Asthma and/or COPD) or healthy controls
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo Intervention | Other | Healthy controls, People with physician-diagnosed disease (Asthma and/or COPD). |
Primary outcome
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.
6 secondary outcomes
Oscillometry
Time frame: Through study completion, minimum of 1 year
The COPD Assessment Test (CAT)
Time frame: Through study completion, minimum of 1 year
Asthma Control Questionnaire (ACQ)
Time frame: Through study completion, minimum of 1 year
Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Through study completion, minimum of 1 year
EQ-5D-5L
Time frame: Through study completion, minimum of 1 year
The Greene Climacteric Scale (GCS)
Time frame: Through study completion, minimum of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Mwasuku contact
Mona Bafadhel principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Lung Disease and Respiratory Ilness, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gill Radcliffe Ms, MRes (+442071888070, gillian.radcliffe@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Function (FEV1 change from baseline) (time frame: Through study completion, minimum of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.