A Randomized, Double-blind, Double-dummy, Active (Formoterol 12 µg b.i.d) and Placebo Controlled, Multi-center, 5 Period Crossover Study to Assess the Bronchodilatory Efficacy and Safety of Single Doses of Indacaterol 150 µg, 300 µg and 600 µg Delivered Via Single Dose Dry Powder Inhaler (SDDPI) vs. Placebo in Patients With Persistent Asthma

Novartis10 个研究点分布在 1 个国家目标入组 45 人开始时间: 2006年11月1日最近更新: 2016年11月18日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Novartis
入组人数: 45
试验地点: 10
主要终点: Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1 day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg, indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a washout-period of 1 week

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 12 Years 至 75 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Males and females 12 - 75 years of age with a diagnosis of persistent asthma
•Daily treatment with a bronchodilator and daily dose of at least 100 µg beclomethasone dipropionate or equivalent
•FEV1 at Visit 1 at least 50% of the predicted normal value
•FEV1 reversibility at least 15%

排除标准

•Use of tobacco products within 6 months prior to Visit 1 or a smoking history of more than 10 pack years
•Chronic Obstructive Pulmonary Disease (COPD)
•Seasonal allergy where asthma is likely to deteriorate during the period of the study
•Emergency room treatment for an acute asthma attack within the previous 6 weeks or hospitalized within the previous 6 months
•A respiratory tract infection within the previous 6 weeks Other protocol-defined exclusion criteria may apply

结局指标

主要结局

Lung function measured 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second "(FEV1)

次要结局

Percent change in FEV1 at time points 30 min, 1, 2 and 4 h, 23 h 10 min and 23 h 45 min post dose
Forced vital capacity (FVC) at time points 30 min, 1, 2 and 4 h, 23 h 10 min and 23 h 45 min post dose
FEV1 at time points 30 min, 1, 2 and 4 h post-dose

研究者

发起方

Novartis

申办方类型

Industry

研究点 (10)

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