A Multi-center, Randomized, Single-dose, Double-blind, 4-way Cross-over Study to Evaluate Tolerability Following Treatment With Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)
研究概览
简要总结
This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 18 to 65 years old (inclusive)
- •Patients with mild to moderate persistent asthma
- •BMI must be within the range of 18-32 kg/m2 inclusive
- •Female subjects must:
- •have been sterilized at least 6 months prior to screening
- •be post-menopausal with no regular bleeding for at least a year prior to inclusion
排除标准
- •Patients with life-threatening arrhythmias
- •Patients with COPD or diabetes mellitus
- •History of immunocompromise, including a positive HIV
- •A positive Hepatitis B surface antigen (HBsAg) of Hepatitis C test result
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Active Comparator 1 different salt formulation of Indacaterol.
干预措施: Indacaterol maleate (Drug)
2
Active Comparator 2 different salt formulation of Indacaterol.
干预措施: Indacaterol maleate (Drug)
3
Active Comparator 3 different salt formulation of Indacaterol.
干预措施: Indacaterol maleate (Drug)
4
干预措施: Placebo (Drug)
结局指标
主要结局
Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)
时间窗: throughout the study
Severity of cough: to be judged independently by both the patient and the physician
时间窗: throughout the study
Duration of coughing
时间窗: throughout the study
Occurrence of cough within 1 minute post dose
时间窗: throughout the study
Number of coughs
时间窗: throughout the study
次要结局
- Severity of cough: to be judged independently by both the patient and the physician(throughout the study)
- Number of coughs(throughout the study)
- Occurrence of cough within 1 minute post dose(throughout the study)
- Duration of coughing(throughout the study)
- Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)(throughout the study)