Evaluation of the Usefulness of Induced Sputum Eosinophilia, eNO and Bronchial Hyperresponsiveness in Predicting the Failure of Inhaled Corticosteroids Dose Reduction in Children and Adolescents With Stable Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- The Percentage of Patients With Loss of Asthma Control
研究概览
简要总结
A prospective, observational, interventional, single-blind study (blinded for a clinician in the field of inflammatory parameters).
The aim of the study is evaluation of the usefulness of induced sputum eosinophilia and other inflammatory indices [exhaled nitric oxide (NO), exhaled breath temperature, bronchial hyperresponsiveness] in predicting the failure of treatment reduction with inhaled corticosteroids (ICS) in stable asthma in children and adolescents.
In participants with a stable course of the asthma (confirmed in the run -in period), every 3 months the dose of ICS is halved (according to GINA guidelines) until the control is lost or the lowest daily ICS dose is reached (200 mcg, calculated as budesonide equivalent). Throughout the treatment reduction period, the participants run an observation card (clinical symptoms) and peak expiratory flow rate (PEFR) measurements. Clinical evaluation is performed every month, with spirometry, exhaled NO and exhaled breath temperature measurements. Before the reduction and then one month after the change of treatment, the hyperresponsiveness measurement is carried out with the sputum induction (combined method using hypertonic saline), and 2 months after the change of treatment with the exercise challenge test.
In the case of loss of asthma control, beta-mimetic will be administered (temporarily) and return to dose of ICS before reduction or further increase of treatment is planned. In severe asthma exacerbations, oral steroids will be considered.
The study is observational: treatment is modified according to GINA guidelines based on clinical data as part of routine medical care. Only difference compared do standard care is supplementary inflammation evaluation (exhaled NO, sputum eosinophilia, bronchial hyperreactivity).
详细描述
Introduction Guidelines for the treatment of asthma recommend the use of the smallest dose of inhaled steroid (ICS), which allows to maintain control of the symptoms of the disease. The GINA 2006 guidelines proposed (and later editions it upheld) that in the case of symptom control by monotherapy with ICS, to reduce their dose every 3 months, up to the lowest dose administered once a day, which should be used for one year before taking possible decision to stop it.
There are no clear of simple and sensitive indicators that would allow detection of a threatening loss of control before the clinical symptoms worsen.
Aim of the study Evaluation of the usefulness of induced sputum eosinophilia and other inflammatory indices [exhaled nitric oxide (NO), exhaled breath temperature (EBT), bronchial hyperresponsiveness] in predicting the failure of treatment reduction with inhaled corticosteroids in stable asthma in children and adolescents.
Subjects Participants aged 12-18 years with stable asthma (mild or moderate), treated in the Allergy Clinic of the Hospital in Lesko with medium doses in ICS. The severity of asthma was initially determined in accordance with the GINA criteria and verified during several years of observation by the assessment of clinical symptoms, functional examinations and the dose of inhaled steroids controlling the disease.
Project description A prospective, observational, single-blind study (blinded for a clinician in the field of inflammatory parameters). Clinician takes decision about possible reduction of ICS dose basing on clinical data only - is not aware of the results of the inflammatory parameters measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Clinician takes decision about possible change in treatment basing on clinical data only - is not aware of the results of the inflammatory parameters measurements
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild or moderate asthma with a stable course of at least 3 months:
- •symptoms less than 4x per week,
- •use of SABA below 3x a week,
- •night awakening below 1x per week,
- •FEV1> 80% of predicted
- •no dose change in ICS or use of systemic steroids from 3 months
- •good adherence to treatment
排除标准
- •infection or exacerbation of asthma requiring the use of systemic steroids (or changes in the dose of inhaled steroids) in the last 3 months before the study
- •other chronic lung diseases or general diseases affecting the respiratory system
- •tobacco smoking
- •FEV1 below 80% of the predicted value
研究组 & 干预措施
stable asthma
In patients with previously stable course of the asthma, every 3 months the symptoms are evaluated and the dose of ICS is customized - in accordance with the GINA guidelines. This decision is based solely on clinical data (control of symptoms) and is the same as in patients not participating in the study.
In patients participating in the study, inflammatory parameters are also measured (sputum eosinophilia, eNO, EBT, bronchial reactivity), but results are not known to clinician taking decision about possible ICS dose reduction.
干预措施: ICS dose reduction (Other)
结局指标
主要结局
The Percentage of Patients With Loss of Asthma Control
时间窗: at 9 months
Criteria for loss of control (any of the following): * use of bronchodilators \> 5 times a week * the need for treatment with oral corticosteroids * PEFR decrease \>20% for 2 consecutive days, compared to the average run-in period
次要结局
- Change in Sputum Eosinophilia(at 1, 3, 4, 6 and 7 month)