A Long Term Follow up Study for a Comparison of Stepwise Treatment of Asthmatic Children With Salmeterol/Fluticasone Propionate Combination Product (SERETIDE®) and/or Fluticasone Propionate (FLIXOTIDE (TM)) Based on PD20 Methacholine and Symptoms or Based on Symptoms Only.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Comparison of the mean annual in FEV1 (% predicted) between randomisation (CATO visit 2) and the current visit 2 between both treatment arms.
研究概览
简要总结
The CATO population is a very well documented population during two years. During this study patients were treated according to the CATO algorithm, after that patient were treated according to the Dutch national (GINA derived) guidelines up to 6 years of follow-up. The purpose of this prospective follow-up study is to understand the long-term effects of treatment. Therefore the measurements done at baseline (CATO part 1) are repeated after 6 years in this CATO-population (CATO follow-up).
详细描述
A long term follow up study for a comparison of stepwise treatment of asthmatic children with Salmeterol/Fluticasone propionate combination product (Seretide®) and/or Fluticasone propionate (Flixotide®) based on PD20 methacholine and symptoms or based on symptoms only ("Children Asthma Therapy Optimal")
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparison of the mean annual in FEV1 (% predicted) between randomisation (CATO visit 2) and the current visit 2 between both treatment arms.
时间窗: 6 years
次要结局
- Comparison of both treatment arms (BHR strategy versus reference strategy):• Lung function FVC and PEFR measured in the clinic between randomisation ( and current visit 2 expressed as the mean annual change of % predicted(6 years)
- • Percentage asthma symptom free days during 6 weeks of this extension study • Bronchial hyperresponsiveness, determined with PD20 methacholine between randomisation and current visit 2(6 years)
- Growth rate between randomisation and current visit 2 (expressed as SD-scores)•frequency of asthma exacerbations between randomisation and current visit 2(6 years)
- • Height at current visit 1 or at last measurement at which subject has reached their final height.• Cumulative ICS doses between randomisation and current visit 2 (if this can be achieved with sufficient reliability)(6 years)
- Quality of Life (Juniper questionnaire)(6 weeks)