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临床试验/NCT06034145
NCT06034145尚未招募不适用

Methacholine Challenge Testing: Comparison of FEV1 and IOS Parameters in Adult Asthma Patients

Allergi- og Lungeklinikken, Elsinore0 个研究点目标入组 500 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
主要终点
ACQ-6

研究概览

简要总结

A classic methacholine challenge test is considered positive when forced expiratory volumen after one second (FEV1) decrease 20%. Impulse oscillometry (IOS) measures airway resistance and reactance, and seems more sensitive to changes in small airways. In adult asthma patients, we compare methacholine challenge test using both FEV1 and IOS.

详细描述

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 (GINA).

In general, FEV1 is used to test for airway hyperresponsiveness (AHR), and a 20% decrease after methacholine challenge is considered a positive test (Coates 2017; ERJ).

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 (Cottini M, J Allergy Clin Immunol Pract 2019; Cottini M, 2022; Postma 2019 Lancet Respir Med).

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.

A recent study showed that patients with a negative methacholine test measured by FEV1 may report asthma-like symptoms and may have a positive test when measured by IOS (Urbankowski; 2021). The question is whether these patients are a subgroup of patients with SAD (based on IOS at baseline) or are characterized in another way.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Doctor diagnosed asthma (based on symptoms and at least one positive asthma test within the last 5 years (AHR; reversibility to beta2-agonist, ICS, prednisolone; peak flow variation).
  • Written informed consent.

排除标准

  • patients aged less than 18 years old.
  • patients with an exacerbation or lower airway infection within 1 months.
  • Pulmonary function test: FEV1 (% pred.) < 60%
  • Not able to perform spirometry or body plethysmography.
  • Cognitive disorders and not able to answer ACQ.
  • Treated with biologics.
  • Pregnancy or breastfeeding
  • Short-acting beta-agonists 6 h, long-acting beta-agonists 2 days, short-acting anti-muscarinic agent 12 h, Long-acting anti-muscarinic agents 7 days, and Montelukast 3 days before methacholine challenge test (MCT).
  • Comorbidity with significant influence on lung function and pulmonary symptoms eg. COPD, bronchiectasis, ischemic heart disease, heart failure, atrial fibrillation, uncontrolled hypertension (>160/100 mmHg), lung cancer, lung resection, BMI>40 kg/m2.

结局指标

主要结局

ACQ-6

时间窗: At entry (Cross sectional)

Asthma Control Questionnaire (ACQ6) will be used in the 6 sub-score version omitting FEV1 % of predicted

Impulse Oscillometry

时间窗: At entry

Resistance at 5Hz (R5), R5-R20, reactance at 5Hz (X5), frequency response (Fres), areal under reactance curve (AX)

Demographic data

时间窗: At entry

General demographic data, including age, sex (male/female), body mass index (BMI) (kg/m2), and smoking history will be recorded.

Asthma medication

时间窗: At entry

Inhaled corticosteroids (ICS), long-acting beta2agonists (LABA), long-acting muscarinic antagonists (LAMA), Leukotriene antagonist, theophylline, and prednisolone - type and dose

Lung function and body box

时间窗: At entry

Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and the percentage of FEV1 in the estimated value will be measured at baseline and after methacholine test by Vyntus, Vyaire Medical. Body plethysmography with residual volumen (RV), total lung capacity (TLC), diffusion capacity of the lungs for carbon monoxide (DLCO), will be measured before methacholine test by Medical Electronic Construction (MEC).

Biomarker

时间窗: At entry

Serum eosinophils and hemoglobin will be measured

FeNO

时间窗: At entry

Measurement of Exhaled Nitric Oxide by NOBreath

次要结局

未报告次要终点

研究者

发起方
Allergi- og Lungeklinikken, Elsinore
申办方类型
Network
责任方
Principal Investigator
主要研究者

Thomas Ringbæk

Principal Investigator

Allergi- og Lungeklinikken, Elsinore

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