NCT02892019已完成2 期
A Multicenter, Randomized, Double-blind, Active-controlled, 2 Week Treatment, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Trough Forced Expiratoty Volume in 1 Second (FEV1)
研究概览
简要总结
This study is designed to explore lung function effects of two doses of indacaterol acetate, 75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic exposure to indacaterol in plasma with historical data in adults, to identify an appropriate dose to Phase III evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children ≥ 6 years and < 12 years with confirmed diagnosis of asthma for at least 1 year prior to study enrollment.
- •Written informed consent by parent(s)/legal guardian(s) and depending upon their age and local requirements a consent or assent for the patient.
- •Patients receiving daily treatment with a stable low dose Inhaled Corticosteroid (ICS) (with or without additional controller), or patients receiving daily treatment with a stable mid-dose ICS (monotherapy or together with LTRA) for at least 4 weeks prior to Screening, and able to tolerate fluticasone propionate 100 μg b.i.d. inhaler starting at Visit 1 (or soon after).
- •Patients with a pre-bronchodilator FEV1 ≥ 50% and ≤ 90% of the predicted normal value for the patient at the start and end of Run-in (Visits 101 and 199).
- •Patients who demonstrate an increase in FEV1 of 12% within 30 minutes after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Visit
- •All patients must perform a reversibility test at Visit 101.
排除标准
- •Patients taking a mid-dose ICS (per GINA guidelines) in combination with LABA or any patient taking high-dose ICS.
- •Evidence of unstable disease within 4 weeks prior to Screening (Visit 1).
- •Patients who have had an asthma attack/exacerbation requiring systemic steroids (SCS) or hospitalization or emergency room visit within 3 months prior to Visit 1 (Screening) or more than 3 separate exacerbations in the 12 months preceding Visit
- •Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Screening (Visit 1).
- •Prior intubation for asthma.
研究组 & 干预措施
Indacaterol acetate 75 μg o.d.
Active Comparator
Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler
干预措施: Indacaterol acetate 75 μg (Drug)
Indacaterol acetate 150 μg o.d.
Active Comparator
Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler
干预措施: Indacaterol acetate 150 μg (Drug)
结局指标
主要结局
Trough Forced Expiratoty Volume in 1 Second (FEV1)
时间窗: 2 weeks
Change from baseline in pre-dose trough FEV1 after 2 weeks of treatment with indacaterol acetate 75 μg o.d and 150 μg o.d. The primary endpoint is change from baseline in pre-dose trough FEV1 (mL) after 2 weeks of treatment. The pre-dose trough FEV1 (mL) is defined as the mean of the two FEV1 (mL), values measured at -45 min and -15 min pre-dose.
次要结局
- Pre-dose Morning and Evening Peak Expiratoty Flow (PEF)(2 weeks)
- Symptoms as Recorded by Patient E-diary (Percentage of Asthma Symptoms Free Days)(2 weeks)
- Rescue Medication Usage (Mean Daiily Number of Puffs)(2 weeks)
- Forced Expiratoty Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)(2 weeks)
- Symptoms as Recorded by Patient E-diary (Mean Total Daily Symptom Score)(2 weeks)
- Asthma Control as Assessed by Pediatric Interviewer-administered Asthma Control Questionnaire(2 weeks)
- Rescue Medication Usage (Percentage of Rescue Medication Free Days)(2 weeks)
- Systemic Exposure to Indacaterol in Plasma(day 1, day 14)
研究者
研究点 (1)
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