Multi-center, Randomized, Double Blind, Double Dummy, Placebo and Active Controlled, Crossover Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg in Stable Mild Asthma Patients
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Post-dose PD20
研究概览
简要总结
Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg
详细描述
To assess the pharmacodynamic bioequivalence of Albuterol Sulfate Inhalation Aerosol 0.09 mg base/ INH [Aurobindo Pharma, USA, Inc] compared to authorized generic drug Albuterol Sulfate HFA Inhalation Aerosol 0.09 mg per actuation [Teva Pharmaceuticals USA, Inc] in stable mild asthma patients, under Methacholine induced bronchoprovocation.
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)
盲法说明
Double Dummy
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).
- •Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
- •FEV1 ≥ 80% of predicted.
- •Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/mL or equivalent PD
- •Nonsmokers for at least six 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
- •Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
- •History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
- •History of cystic fibrosis, bronchiectasis or other respiratory diseases.
- •History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease.
- •Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months.
- •Known intolerance or hypersensitivity to any component of the albuterol MDI
研究组 & 干预措施
Zero dose:
干预措施: Methacholine Chloride (Other)
Zero dose:
干预措施: Placebo (Drug)
Reference 0.09 mg
干预措施: Methacholine Chloride (Other)
Reference 0.09 mg
干预措施: Albuterol Sulfate HFA 0.09 mg (Reference) (Drug)
Reference 0.18 mg
干预措施: Methacholine Chloride (Other)
Reference 0.18 mg
干预措施: Albuterol Sulfate HFA 0.18 mg (Reference) (Drug)
Test 0.09 mg
干预措施: Methacholine Chloride (Other)
Test 0.09 mg
干预措施: Albuterol Sulfate HFA 0.09 mg (Test) (Drug)
Test 0.18 mg
干预措施: Methacholine Chloride (Other)
Test 0.18 mg
干预措施: Albuterol Sulfate HFA 0.18 mg (Test) (Drug)
结局指标
主要结局
Post-dose PD20
时间窗: Over a period of 4 weeks
Provocative dose of the methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing doses of albuterol (or placebo) by inhalation.
次要结局
未报告次要终点