Sub-Sensitivity to Long-Acting Bronchodilators (LABA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement in PC20
研究概览
简要总结
The purpose of this study is to look at whether Advair® and SYMBICORT® have different effects on airway constriction by means of methacholine challenge testing.
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
- None
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
- •20 subjects males or females 18-65 years of age with physician diagnosed asthma Diagnosis of asthma > 12 months Currently on 2 puffs SABA bid. Baseline percent FEV1 of greater than 60% and less than or equal to 100% 12% reversibility in the previous 12 months 12% reversibility at Screening Visit Positive MTC (≤ 8mg/ml) at the end of 2 week Run-In Currently symptomatic with ACT score less than 19 at the end of run in on ICS ≥ 200 and ≤ 400 ug/day Non-smoker or ex-smoker with < 10 pk year who stopped > 1 year ago
排除标准
- •Asthma exacerbation, significant airflow obstruction, or respiratory infection between Visits 0 and
- •Patients who fail screening because of one of these events may be re-screened once (at least 4 weeks after recovery from the event).
- •Pre-existing lung disease other than asthma, including active infections Clinically significant medical disease that is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study Noncompliance or inability to participate in all assessments. Current smoker or former smoker with a lifetime smoking history of ≥ 10 pack-years. A current smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or a pipe or cigar) for >/= 30 days within the 24 months prior to Visit
- •Any individual who smokes (cigarettes, marijuana, pipe, or cigar) occasionally, even if for < 30 days in the 24 months Prior to Visit 1, must agree to abstain from all smoking from the time of consent through completion.
- •History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator.
- •Participation in another interventional clinical trial (including a trial of an approved drug or an interventional study that does not include medication) within 30 days or 5 half-lives of the investigational agent, whichever is longer.
- •Women with a positive urine pregnancy test.
研究组 & 干预措施
fluticasone propionate and salmeterol
干预措施: fluticasone propionate and salmeterol (Drug)
fluticasone propionate and salmeterol
干预措施: budesonide and formoterol (Drug)
budesonide and formoterol
干预措施: fluticasone propionate and salmeterol (Drug)
budesonide and formoterol
干预措施: budesonide and formoterol (Drug)
结局指标
主要结局
Improvement in PC20
时间窗: Study Completion
Improvements in PC20 as measured by methacholine challenge between the two treatment groups at the end of the first 4 week period to determine efficacy between low dose Advair and Symbicort.
Improvement in PC20
时间窗: A baseline methacholine challenge was compared to the methacholine challenge performed after 4 weeks of treatment for each arm.
Improvements in PC20 as measured by methacholine challenge between the two treatment groups at the end of the first 4 week period to determine efficacy between low dose Advair and Symbicort.
次要结局
- Changes in FEV1(Study Completion)