Steroid-sparing Management of the Salmeterol/Fluticasone 50/100µg b.i.d. Combination Compared to Fluticasone 200µg b.i.d. in Children and Adolescents With Moderate Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Change from Baseline in mean morning peak expiratory flow (PEF)
研究概览
简要总结
Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an adjustment of their asthma therapy. Current guidelines suggest that the treatment options are either an increased dose of inhaled corticosteroid or the addition of other therapy such as a long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to high dose ICS therapy are growth retardation and the suppression of the hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that a combination product that included a LABA as well as the ICS allowed to reduce the steroid dose and was still at least as effective in achieving asthma control as treatment with a higher dose of ICS. These treatment options shall be compared in the present study. Children who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of eight weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 16 years with an established history of perennial asthma.
- •Subjects who are treated with an inhaled corticosteroid according to BDP (budesonide) 200-400 µg/day or equivalent during the last 4 weeks before run-in.
- •15 minutes after inhaling 200µg of salbutamol, reversible increase in FEV1 of at least 12% of the pre-dose value.
- •Willingness to substitute previous controller medication on the twice daily inhalation of fluticasone 100µg bid via DISKUS®.
- •Subjects/guardians who have given written informed consent to participate in the study.
- •Subjects /guardians who are able to understand and complete a diary record card (DRC).
- •Subjects who are able to use a Mini-Wright Peak Flow meter.
- •Sexually active female adolescents must use adequate contraception.
- •Willingness to refrain from any other controller medication (including anti-leukotrienes) or from regular use of short-acting beta agonists or anticholinergics during the treatment period.
排除标准
- 未提供
研究组 & 干预措施
Subjects receiving salmeterol/fluticasone
Eligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo.
干预措施: Salmeterol/fluticasone (Drug)
Subjects receiving salmeterol/fluticasone
Eligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo.
干预措施: Salbutamol (Drug)
Subjects receiving fluticasone
Eligible subjects will receive 60 individual fluticasone 100 microgram doses each.
干预措施: Fluticasone propionate (Drug)
Subjects receiving fluticasone
Eligible subjects will receive 60 individual fluticasone 100 microgram doses each.
干预措施: Salbutamol (Drug)
结局指标
主要结局
Change from Baseline in mean morning peak expiratory flow (PEF)
时间窗: Baseline up to Week 8
The PEF is a person's maximum speed of expiration. PEF will be measured using a mini wright peak flow meter and will be documented daily at morning in the diary of subjects
次要结局
- Change in forced expiratory volume in 1 second (FEV1) in % of reference value(Up to Week 8)
- Change in peak expiratory flow rate (PEFR) in % of reference value(Up to Week 8)
- Daily Asthma symptom score(Up to Week 8)
- Number of calendar days without asthma symptoms(Up to Week 8)
- Number of necessary administrations of salbutamol(Up to Week 8)
- Number of weeks with good asthma control(Up to Week 8)
- Change in forced vital capacity (FVC) in % of reference value(Up to Week 8)
- Change in mean morning peak flow in % of reference value(Up to Week 8)
- Percentage of subjects with a peak flow variability of 20%(Up to Week 8)
- Number of subject withdrawals due to asthma exacerbations(Up to Week 8)
- Number of subjects with adverse events (AEs)(Up to Week 8)