NCT01286532已完成不适用
A Six-month Non-interventional Prospective Study of Various Controller Therapies for Moderate Persistent and Severe Persistent Asthma in Children in Real Life Outpatient Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 283
- 试验地点
- 1
- 主要终点
- To compare percentage (%) of responding children by the end of 6-month observation. Responders are defined as children with adequate control of symptoms at the end of 6 months observation (Childhood Asthma Control Test (CACT) score > 19)
研究概览
简要总结
This is a six-month non-interventional prospective study of various controller therapies in children with asthma in outpatient clinical practice.
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
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child (male or female) aged 5 to 11 years inclusive
- •Provision of Subject Informed Consent Form for anonymous data collection and their subsequent use (must be signed by any of the parents)
- •The child must be included in an out-patient observation program at a medical institution for established bronchial asthma diagnosis for at least 1 year prior to enrolment and diagnosed with moderate to severe bronchial asthma at the time of enrolment
- •The child must have at least one documented bronchial asthma exacerbation in previous 1 year (including hospital admissions for bronchial asthma exacerbations, any cases of daytime hospital treatment without overnight stays and any cases of oral administration of glucocorticoids on an out-patient basis for > 3 consecutive days)
- •Out-patient receiving step 3 controller treatments with fixed dose combinations of ICSs and LABA or treatment with separate administration of glucocorticoids and LABA in stable doses with adequate control of bronchial asthma symptoms
- •The patient administered with short-acting β2 agonists (inhalational) or rapidly released methylxanthines (oral) in the doses approved for the respective age as a rescue on-demand therapies during the preceding month
排除标准
- •Cystic fibrosis, α1-antitrypsin deficiency or congenital abnormalities of lung development
- •Severe comorbidities affecting the patient's overall performance
- •In the physician's opinion, the patient is not able to comply with the protocol requirements
- •Expected specific hyposensibilization within next 6 months
- •Expected treatment at health resort facilities within next 6 months
- •Other reasons that in the physician's opinion will prevent reliable assessments of the study treatment efficacy
结局指标
主要结局
To compare percentage (%) of responding children by the end of 6-month observation. Responders are defined as children with adequate control of symptoms at the end of 6 months observation (Childhood Asthma Control Test (CACT) score > 19)
时间窗: 3 visits for 6 month
次要结局
- To determine mean number of severe bronchial asthma exacerbations within 6 months(3 visits for 6 month)
- To determine mean duration of bronchial asthma exacerbations including hospital admissions, daytime hospital treatment and any cases of oral administration of glucocorticoids > 3 consecutive days during the observation period(3 visits for 6 month)
- To determine mean requirement in short-acting β2-agonists and/or rapidly released methylxanthines per week during the period of observation(3 visits for 6 month)
- To determine the independent factors associated with failure of treatment of asthma (demographic and baseline patient data, site)(3 visits for 6 month)
研究者
研究点 (1)
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