Patients' Compliance to Home Nebulizer Therapy for Children's Asthma in China An Observational Study to Investigate the Compliance of Home Nebulizer Therapy Among Children Aged 0-14 Years Old Clinically Diagnosed With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 512
- 试验地点
- 2
- 主要终点
- Median treatment compliance (%) derived using actual treatment frequency (monitored by electronic chips) divided by prescribed frequency
研究概览
简要总结
An observational study to investigate the compliance of home nebulizer therapy among children aged 0-14 years old clinically diagnosed with asthma
详细描述
Asthma is the most common chronic disease of childhood and the leading causes of childhood morbidity from chronic disease (GINA 2016). It is clear that inhaled corticosteroid (ICS) is foundation of asthma treatment and recommended both in Global Initiative for Asthma (GINA) and Chinese paediatric asthma diagnosis and treatment guideline. But the well-controlled rate of asthma was not ideal. National Parents of Asthmatic Children KAP Project Team (China) showed that 66.0% asthmatic children had asthma attacks in the past 12 months, 26.8% asthmatic children had visited the emergency department and 16.2% asthmatic children had been hospitalized. (Asthmatic Children KAP project team, 2013) .A few studies showed an increased risk of uncontrolled asthma or an asthma exacerbation in children with lower compliance (Jentzsch NS, 2012; Milgrom H, 1996). Poor compliance to inhaled corticosteroids may also contribute to poor asthma control level and asthma mortality (GINA 2016). Home nebulizer therapy has been recommended in GINA and Chinese Paediatric asthma diagnosis and treatment guideline. Compare to other inhalers, delivering ICS through nebulizer therapy need minimal patient's cooperation and normal breathing pattern (Deborah Elliott, 2011), but there are no studies to show the compliance of home nebulizer therapy in Chinese clinical practice. So we aim to investigate the compliance to home nebulizer therapy, and try to explore the related risk factor with poor compliance in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 0-14 years old, clinical diagnosed as asthma according to Chinese paediatric asthma diagnosis and treatment guideline
- •Prescribed home nebulizer therapy for at least 3 month
- •The guardians must sign the Informed Consent Form; Subjects who can make decision by him/herself must also sign the Informed Consent Form
- •Diagnosis of paediatric asthma:
- •The patient who fulfil criteria 1 to 4 or criteria 4 plus any item of criteria 5 could be diagnosed as paediatric asthma.
- •Recurrent respiratory symptoms (wheeze, cough, dyspnoea, chest tightness), typically worse at night/early morning, exacerbated by exercise, viral infection, smoke, dust, pets, mold, dampness, weather changes, laughing, crying, allergens.
- •A musical, high-pitched whistling sound could be detected in both sides of the lung by auscultation of the chest. The wheezing is usually during exhalation.
- •Symptoms/signs above could be relieved automatically or by anti-asthmatic treatment.
- •Exclusion of the other diseases, which also could cause wheeze, cough, dyspnoea, chest tightness.
- •Atypical symptoms/signs without any wheeze or whistling sound (at least fulfil one of the following criteria):
- •The results of bronchial provocation test is positive. 2) Demonstrating reversible airflow limitation: i. The result of bronchial dilation test is positive. ii. Anti-asthmatic treatment is effective for lung function improvement. 3) The ratio of daily variation of PEF (consecutively more than two weeks) is more than 13%.
排除标准
- •Allergy to any inhaler cortical steroid
- •Presenting with differential diagnosis of asthma such as congenital heart disease, gastro-oesophageal reflux, bronchopulmonary dysplasis, bronchiolitis obliterans, etc
- •Parents/Guardian have problem in expression, understanding, writing and reading in Chinese judged by the investigator
- •Subjects are participating other on-going clinical studies
- •Subjects with other diseases that may interfere the study results judged by the investigators
结局指标
主要结局
Median treatment compliance (%) derived using actual treatment frequency (monitored by electronic chips) divided by prescribed frequency
时间窗: From 3 June 2017 to 3 March 2018, an expected average of 3 months
次要结局
- Proportion of patients in different treatment compliance levels (<50%, 50 %≤-< 80%, 80%≤-≤120%, >120%) monitored by electric chips(From 3 June 2017 to 3 March 2018, an expected average of 3 months)
- Factors associated with treatment compliance(From 3 June 2017 to 3 March 2018, an expected average of 3 months)
- The proportion of asthma control status (controlled, partly controlled and uncontrolled asthma) according to GINA 2016 definition at visit 2 to 4 overall and by compliance level.(From 3 June 2017 to 3 March 2018, an expected average of 3 months)
- The proportion of asthma control status according to TRACK for subjects under 5 years old(From 3 June 2017 to 3 March 2018, an expected average of 3 months)
- Median treatment compliance (%) reported by caregivers derived using actual doses divided by prescribed doses(From 3 June 2017 to 3 March 2018, an expected average of 3 months)
- Proportion of patients in difference compliance levels reported by caregivers(From 3 June 2017 to 3 March 2018, an expected average of 3 months)
- Proportion of patients by severity(From 3 June 2017 to 3 March 2018, an expected average of 3 months)
- Factors associated with control levels (controlled, partly controlled and uncontrolled asthma)(From 3 June 2017 to 3 March 2018, an expected average of 3 months)