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Идёт набор NCT06509659

Methacholine Challenge Test (MCT) in Healthy Adults

— Наблюдательное Hyperreactive Airway Disease

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: Methacholine Challenge Test.
Кому может быть актуально
Состояния в реестре: Hyperreactive Airway Disease. Базовые параметры: 18 лет — 65 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
Дания
Следующий шаг
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Официальное название

Methacholine Challenge Test (MCT) in Healthy Adults: Oscillometry Measured Alone Compared to Oscillometry and FEV1 During the Same Test

Обзор

Knowledge of Methacholine Challenge Test (MCT) and impedance Oscillometry (IOS) is limited. Only three studies have included adult patients, and none of these with healthy controls. The three studies have combined IOS and spirometry in the same test, although it is not recommended to perform IOS after a test that requires deep breathing, e.g. FEV1 measurement. Deep breathing is considered to affect the impedance via reduced tone in the smooth muscle.

Подробное описание

Asthma is a common chronic disease that is characterized by a history of variable respiratory symptoms and variable expiratory airflow limitation, and usually associated with airway hyperresponsiveness.

In general, FEV1 is used to test for airway hyperresponsiveness (AHR), and a 20% decrease after methacholine challenge test (MCT) is considered a positive test.

There is increasing recognition that the small airways are involved in 40-80% of patients with asthma, and the function of these airways is overlooked (the "silent zone") when measuring FEV1, which mainly reflects the function of the central airways.

Small airway dysfunction (SAD) can be assessed by IOS where pressure applied to the airways at a range of frequencies, and components of respiratory resistance and reactance are measured. Resistance at 5 Hz (R5) and 20 Hz (R20), respectively, represent total airway resistance and proximal airway resistance. The difference between these two values can be calculated (R5-R20). High R5-R20 and low reactance at 5 Hz (X5) indicate the presence of SAD.

Knowledge of MCT and IOS is limited. Only three studies have included adult patients, and none of these with healthy controls. These studies have combined IOS and spirometry in the same test, although it is not recommended to perform IOS after a test that requires deep breathing, e.g. FEV1 measurement. Deep breathing is considered to affect the impedance via reduced tone in the smooth muscle.

The investigators have the following objectives for these studies:

1. To determine the IOS response to MCT in healthy adults. 2. To investigate whether spirometry (FEV1) carried out in relation to MCT influences IOS by comparing the IOS response to MCT performed with and without spirometry in healthy adults.

Вмешательства

  • Диагностический тест Methacholine Challenge Test
    MCT with IOS alone versus MCT IOS and FEV1 combined

Первичные конечные точки

  • Oscillometry; R5 [Срок оценки: baseline (carried out with FEV1 measurement)]
  • Oscillometry; R5 [Срок оценки: 1-10 days from baseline and carried out without FEV1 measurement]
  • Oscillometry; R20 [Срок оценки: baseline (carried out without FEV1 measurement)]
  • Oscillometry; R20 [Срок оценки: 1-10 days from baseline and carried out without FEV1 measurement]
  • Oscillometry; X5 [Срок оценки: baseline (carried out without FEV1 measurement)]
  • Oscillometry; X5 [Срок оценки: 1-10 days from baseline and carried out without FEV1 measurement]
  • Oscillometry; AX [Срок оценки: baseline (carried out without FEV1 measurement)]
  • Oscillometry; AX [Срок оценки: 1-10 days from baseline and carried out without FEV1 measurement]
  • Oscillometry; Fres [Срок оценки: baseline (carried out without FEV1 measurement)]
  • Oscillometry; Fres [Срок оценки: 1-10 days from baseline and carried out without FEV1 measurement]

Критерии участия

Критерии включения

  • Forced expiratory volume in the 1. second (FEV1) >80%
  • FEV1/FVC-ratio >0,7
  • FeNO <25 pbb
  • Oxygen saturation (SatO2) >95%
  • Negative methacholine Challenge Test = drop in FEV1 less than 20%

Критерии исключения

  • Any lung disease
  • Lung symptoms
  • Medicine for lung disease
  • Tobacco smoking
  • Ex-smokers with more than 5 package years
  • BMI (body mass index) >40 kg/m2

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Дания · 1 центр
  • Thomas Ringbæk — Elsinore

Публикации

  • Coates AL, Wanger J, Cockcroft DW, Culver BH; Bronchoprovocation Testing Task Force: Kai-Hakon Carlsen; Diamant Z, Gauvreau G, Hall GL, Hallstrand TS, Horvath I, de Jongh FHC, Joos G, Kaminsky DA, Laube BL, Leuppi JD, Sterk PJ. ERS technical standard on bronchial challenge testing: general considerations and performance of methacholine challenge tests. Eur Respir J. 2017 May 1;49(5):1601526. doi: PMID 28461290
  • Cottini M, Lombardi C, Passalacqua G, Bagnasco D, Berti A, Comberiati P, Imeri G, Landi M, Heffler E. Small Airways: The "Silent Zone" of 2021 GINA Report? Front Med (Lausanne). 2022 May 23;9:884679. doi: 10.3389/fmed.2022.884679. eCollection 2022. PMID 35677830

Идентификаторы

NCT: NCT06509659 · Elsinore_Healthy

Первоисточники (государственные реестры)

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