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Идёт набор NCT06713512

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

— Наблюдательное Chronic Obstructive Lung Disease Respiratory Ilness Estrogen Deficiency Asthma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No intervention.
Кому может быть актуально
Состояния в реестре: Chronic Obstructive Lung Disease, Respiratory Ilness, Estrogen Deficiency, Asthma. Базовые параметры: 18 лет — 99 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое No intervention
    No Intervention

Первичные конечные точки

  • Lung Function (FEV1 change from baseline) [Срок оценки: Through study completion, minimum of 1 year]
Вторичные конечные точки (6)
  • Oscillometry [Срок оценки: Through study completion, minimum of 1 year]
  • The COPD Assessment Test (CAT) [Срок оценки: Through study completion, minimum of 1 year]
  • Asthma Control Questionnaire (ACQ) [Срок оценки: Through study completion, minimum of 1 year]
  • Asthma Quality of Life Questionnaire (AQLQ) [Срок оценки: Through study completion, minimum of 1 year]
  • EQ-5D-5L [Срок оценки: Through study completion, minimum of 1 year]
  • The Greene Climacteric Scale (GCS) [Срок оценки: Through study completion, minimum of 1 year]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • Guys & St Thomas NHS Foundation Trust — London

Идентификаторы

NCT: NCT06713512 · 326236

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗