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Идёт набор NCT04157361

Pulmonary Condensate: Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.

— Наблюдательное Bronchial Asthma Pulmonary Cystic Fibrosis

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: Collection of breath condensate.
Кому может быть актуально
Состояния в реестре: Bronchial Asthma, Pulmonary Cystic Fibrosis. Базовые параметры: Без ограничений · 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
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pulmonary Condensate: A Promising Source of Proteomic Biomarkers for Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.

Обзор

Exhaled breath condensate (EBC) represents a rich source for countless biomarkers that can provide valuable information about respiratory as well as systemic diseases. Finding non-invasive methods for early detection of lung injury, inflammation and infectious complications in chronic diseases like (CF) Cystic fibrosis or (AB) Bronchial asthma would be highly beneficial. Investigators propose to establish EBC "breathprints" revealing molecular signatures of pulmonary inflammation and specific respiratory bacterial infections of CF patients and AB. Investigators hypothesize that the analysis of EBC can reveal biomarkers specific for severity of the inflammation, and infection caused by opportunistic pathogens such as P. aeruginosa (PA). With these breath-prints, investigators also propose to establish correlations between respiratory microbiota using traditional methods and CF lung disease severity. Together, the studies will advance the development and validation of EBC as a novel tool for the proper diagnosis of AB and monitoring of CF disease activity, treatment efficacy and PA or another opportunistic infections.

Подробное описание

Exhaled breath condensate (EBC) represents a rich source for countless biomarkers that can provide valuable information about respiratory as well as systemic diseases. Finding non-invasive methods for early detection of lung injury, inflammation and infectious complications in chronic diseases like Cystic fibrosis (CF) or Bronchial asthma (AB) would be highly beneficial. Investigators propose to establish EBC "breathprints" revealing molecular signatures of pulmonary inflammation and specific respiratory bacterial infections of CF patients and AB. Investigators hypothesize that the analysis of EBC can reveal biomarkers specific for severity of the inflammation, and infection caused by opportunistic pathogens such as P. aeruginosa (PA). With these breath-prints, investigators also propose to establish correlations between respiratory microbiota using traditional methods and CF lung disease severity. Together, the studies will advance the development and validation of EBC as a novel tool for the proper diagnosis of AB and monitoring of CF disease activity, treatment efficacy and PA or another opportunistic infections.

Вмешательства

  • Диагностический тест Collection of breath condensate
    Breath condensate will be collected from the patients involved in study.

Первичные конечные точки

  • Biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine [Срок оценки: 18 months from the screening]
  • FEV1 determination in Cystic Fibrosis patients [Срок оценки: 18 months from the screening]
  • FVC determination in Cystic Fibrosis patients [Срок оценки: 18 months from the screening]
  • Amylase readings in blood serum in Cystic Fibrosis patients [Срок оценки: 18 months from the screening]
  • Lipase readings in blood serum in Cystic Fibrosis patients [Срок оценки: 18 months from the screening]
  • Microbiology cultivation in Cystic Fibrosis patients [Срок оценки: 18 months from the screening]
  • CT in Cystic Fibrosis patients [Срок оценки: 18 months from the screening]
  • RTG in Cystic Fibrosis patients [Срок оценки: 18 months from the screening]
Вторичные конечные точки (1)
  • Inflamatory biomarker identification using method of High Resolution Mass Spectrometry processed on Orbitrap Velos Elite machine [Срок оценки: 18 months from the screening]

Критерии участия

Критерии включения

  • Children/adults with moderate or IgE mediated asthma
  • Children/adults with cystic fibrosis
  • Healthy control children/adults without lung disorders

Критерии исключения

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Чехия · 1 центр
  • University Hospital Olomouc — Olomouc

Идентификаторы

NCT: NCT04157361 · 122

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗