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

NCT06713512 | Recruiting

• 1 other identifier: 326236
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Chronic Obstructive Lung Disease; Respiratory Ilness; Estrogen Deficiency; Asthma

Keywords

Asthma; COPD

Outcome Measures

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.

  Through study completion, minimum of 1 year

Secondary Outcomes (6)

• Oscillometry

  Through study completion, minimum of 1 year

• The COPD Assessment Test (CAT)

  Through study completion, minimum of 1 year

• Asthma Control Questionnaire (ACQ)

  Through study completion, minimum of 1 year

• Asthma Quality of Life Questionnaire (AQLQ)

  Through study completion, minimum of 1 year

• EQ-5D-5L

  Through study completion, minimum of 1 year

Study Arms (2)

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

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

Other: No intervention

Healthy controls

People with no physician-diagnosed disease (Asthma and/or COPD).

Other: No intervention

Interventions

No intervention OTHER

No Intervention

Healthy controls; People with physician-diagnosed disease (Asthma and/or COPD).

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guys & St Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mona Bafadhel

  King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gill Radcliffe Ms, MRes

CONTACT

+442071888070; gillian.radcliffe@gstt.nhs.uk

Chris Mwasuku

CONTACT

Christine.Mwasuku@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: December 3, 2024
• Study Start: December 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

GB (1)