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
- 110
- 试验地点
- 1
- 主要终点
- Provocative Concentration of Methacholine Causing 20 % Fall (PC20) 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
- •Male and non-pregnant female subjects (18-65 years of age)
- •Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of predicted. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.
- •Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
- •Nonsmokers for at least 6 months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
- •Written informed consent.
排除标准
- •Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within six weeks prior to the screening visit.
- •History of seasonal asthma exacerbations, in which case the patient should be studied outside of the relevant allergen season.
- •History of a clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia.
- •History of cystic fibrosis, bronchiectasis or other respiratory diseases other than Asthma
- •Historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases
- •Known intolerance or hypersensitivity or hypersensitivity to any component of the albuterol metered dose inhaler (MDI).
研究组 & 干预措施
Placebo Product
One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols
干预措施: Placebo (Drug)
90 mcg Reference Product
Drug : 90 mcg Reference Product One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols
干预措施: 90 mcg Reference Product (Drug)
180 mcg Reference Product
Drug: 180 mcg Reference Product One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols
干预措施: 180 mcg Reference Product (Drug)
90 mcg Test Product
Drug: 90 mcg Test Product One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols
干预措施: 90 mcg Test Product (Drug)
结局指标
主要结局
Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second)
时间窗: 1 day
次要结局
未报告次要终点