NCT00393991已完成3 期
A Randomized, Double-blind, Placebo-controlled, Parallel, Stratified, Multi-center, 12-Week Study Comparing the Safety & Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm)100/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI)With the Administration of Placebo or Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Mild to Moderate Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 475
- 试验地点
- 2
- 主要终点
- Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with mild to moderate asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of asthma for at least 12 months.
- •For steroid-requiring patients, documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit
- •For steroid-free patients, no history of inhaled steroid asthma medication for at least 12 weeks prior to Screening Visit.
- •Demonstrate FEV-1 of 60-85% of predicted normal values at Screening and Baseline Visit.
- •Documented reversibility of 15% within 12 months of Screening or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation or nebulized albuterol administration).
- •Symptoms of Asthma during Run-in
- •Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating, and are either sterile, or using acceptable methods of contraception.
- •Must otherwise be healthy.
- •Provide written informed consent. Wishes of minors must be respected.
排除标准
- •Life-threatening asthma within past year or during Run-In Period.
- •History of systemic corticosteroid medication within 3 months before Screening Visit.
- •History of omalizumab use within past 6 months.
- •History of leukotriene receptor antagonist use, e.g. montelukast, within past week.
- •Current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
- •Upper or lower respiratory infection within 4 weeks prior to Screening Visit or during Run-In Period.
- •Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease [COPD], cystic fibrosis, bronchiectasis).
- •Known Human Immunodeficiency Virus (HIV)-positive status.
- •Smoking history equivalent to "10 pack years".
- •Current smoking history within 12 months prior to Screening Visit.
- •Current evidence or history of alcohol and/or substance abuse within 12 months prior to Screening Visit.
- •Patients who are confined in institution
研究组 & 干预措施
1
Experimental
FlutiForm 100/10 μg
干预措施: Fluticasone propionate/formoterol fumarate 100/10 (Drug)
2
Active Comparator
Fluticasone 100 μg
干预措施: Fluticasone propionate 100 (Drug)
3
Active Comparator
Formoterol 10 μg
干预措施: Formoterol fumarate 10 (Drug)
4
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy
时间窗: Week 0 and 12 visits
次要结局
- Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR).(Whole duration of study)
- Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).(Whole duration of study)
- Safety variables including adverse events, ECGs, clinical laboratory tests and vital signs.(Whole duration of study)
- Serial 12-hour FEV-1 area under the curve (AUC).(Week 0, 2 and 12 visits)
研究者
研究点 (2)
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