To Compare the Bronchoprotective Effects of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Methacholine Bronchoprovocation Challenge Testing in Stable Mild Asthma Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Cipla Ltd.
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Provocative Dose of Methacholine Causing 20 % Fall (PD20) in FEV1(Forced Expiratory Volume in 1 second)
研究概览
简要总结
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
详细描述
This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
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
- Double (Participant, Investigator)
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
- •Subject must have a ≥6-months diagnosis of stable mild asthma based on National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP EPR3) guidelines (NAEPP EPR3, 2007)
- •Subject must demonstrate an FEV1 ≥1.5L and ≥80% of predicted based on NHANES III predicted values at the pre-challenge/Pre-saline stage of the first screening MBPC
- •a. If a subject's FEV1 at the pre-challenge (baseline/Pre-saline) spirometry is <80%, but ≥70%, the screening visit may be rescheduled one time (visit must take place within 7 days)
- •Subject must demonstrate airway responsiveness to methacholine at baseline (pre-albuterol dose) PC20 at ≤8 mg/mL concentration of methacholine (Equivalent to PD20 of ≤513 µg) at the first screening MBPC
- •Subject must have a BMI of ≥18 kg/m2 and ≤35 kg/m2 at screening.
排除标准
- •Subject has a fall in FEV1 at the saline stage ≥10% at the screening MBPC.
- •Subject having FEV1 of less than 1.5L at pre-challenge or saline stage of MBPC at any visit. No re-screening/re-scheduling is allowed for such subjects.
研究组 & 干预措施
Placebo Product
One actuation each from four different placebo inhalation aerosols.
干预措施: Placebo (Drug)
Test Product
One actuation from the test inhalation aerosol and one actuation each from three different placebo inhalation aerosols
干预措施: Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) (Drug)
Reference 90mcg Product
One actuation from the reference inhalation aerosol and one actuation each from three different placebo inhalation aerosols.
干预措施: Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1 (Drug)
Reference 180mcg Product
One actuation each from two different reference inhalation aerosols and one actuation each from two different placebo inhalation aerosols
干预措施: Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2 (Drug)
结局指标
主要结局
Provocative Dose of Methacholine Causing 20 % Fall (PD20) in FEV1(Forced Expiratory Volume in 1 second)
时间窗: 1 day
• To compare the bronchoprotective effects of the test product, Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) \[InvaGen Pharmaceuticals Inc., (a subsidiary of Cipla Ltd.) Fall River - MA02720\] with the Reference product, Ventolin HFA (Albuterol sulfate inhalation aerosol) 90 mcg per actuation (GlaxoSmithKline, USA), as assessed by methacholine bronchoprovocation challenge (MBPC) testing
次要结局
未报告次要终点