Randomized, Double-Blind, Chronic Dosing (4 Weeks), Four-Period, Five-Treatment, Incomplete Block, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Four Doses of Budesonide Inhalation Aerosol (BD MDI, PT008) Relative to Placebo MDI in Adult Subjects With Mild to Moderate Persistent Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period
研究概览
简要总结
Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.
详细描述
This is a randomized, double-blind, chronic dosing (4 weeks), four-period, five-treatment, incomplete block, cross-over, multicenter study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent 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)
盲法说明
Double Blind
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
- •≥ 18 - 65 years of age
- •Diagnosis of mild to moderate persistent asthma, diagnosed at least 6 months prior to screening
- •Currently receiving treatment with a low to medium dose of an inhaled corticosteroid (ICS) OR a combination of controller medications for at least 4 weeks preceding screening
- •Pre-albuterol FEV1 of > 60% and < 85% of predicted normal value
- •Reversibility: Increase in FEV1 of ≥ 12% and ≥ 200 mL over the pre-albuterol FEV1 within 30 - 60 minutes after the inhalation of 4 puffs of Ventolin hydrofluoroalkane (HFA)
- •Asthma Symptom Criteria: Have required albuterol use on at least two of the last seven days and have an Asthma Control Questionnaire (ACQ) total score ≥ 1.5 prior to Randomization
排除标准
- •Life-Threatening Asthma: A subject must not have life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within the 12 months prior to screening
- •Worsening of Asthma: A subject must not have experienced a worsening of asthma which involved an emergency department visit, hospitalization or use of oral/parenteral corticosteroids within 6 weeks of screening
- •Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only intermittent, seasonal or exercise-induced asthma are excluded from participation in this study
- •Concurrent Respiratory Disease
- •Pregnant women or nursing mothers
- •A current diagnosis of Chronic Obstructive Pulmonary Disease (COPD
- •Current smokers or subjects with a > 10 pack year history of cigarettes, cigars, or pipe smoking
- •Respiratory tract infection within 6 weeks prior to Visit 1
- •Subjects with documented myocardial infarction within a year from screening visit
- •Clinically significant abnormal ECG
- •Abnormal liver function tests defined as aspartate aminotransferase (AST), alanine aminotransferace (ALT), alkaline phosphatase or total bilirubin ≥ 1.5 times upper limit of normal on repeat testing
- •Subjects who have cancer that has not been in complete remission for at least 5 years
- •Drug Allergy: Subjects who have a history of hypersensitivity to any component of the metered-dose inhaler (MDI)
研究组 & 干预措施
BD MDI 320 µg
Budesonide metered dose inhaler (BD MDI) 320 µg (PT008) administered as 2 inhalations BID
干预措施: BD MDI 320 µg (Drug)
BD MDI 160 µg
BD MDI 160 µg (PT008) administered as 2 inhalations BID
干预措施: BD MDI 160 µg (Drug)
BD MDI 80 µg
BD MDI 80 µg (PT008) administered as 2 inhalations BID
干预措施: BD MDI 80 µg (Drug)
BD MDI 40 µg
BD MDI 40 µg (PT008) administered as 2 inhalations BID
干预措施: BD MDI 40 µg (Drug)
Placebo MDI
Placebo MDI administered as 2 inhalations BID
干预措施: Placebo MDI (Drug)
结局指标
主要结局
Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period
时间窗: Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)
Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.
次要结局
- Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)(Baseline to Last 7 Days of Treatment Period)
- Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score(Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing))
- Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)(Baseline to Last 7 Days of Treatment Period)
- Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA(Baseline to Last 7 Days of Treatment)