NCT00394121已完成3 期
Long-term Open-label Safety Study With SkyePharma FlutiForm HFA pMDI (100/10 µg and 250/10 µg) in Adult and Adolescent Patients With Asthma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 28
- 主要终点
- Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months.
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of the fixed combination asthma drug FlutiForm HFA MDI (containing fluticasone propionate and formoterol fumarate) in adult and adolescent patients with mild to moderate-severe asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring.
- •Inclusion Criteria:
- •History of asthma for at least 12 months.
- •Documented use of inhaled corticosteriod for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
- •Documented reversibility of 15% within 6 months of Screening Visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation).
- •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 the past 6 months.
- •History of leukotriene receptor antagonist use, e.g., montelukast, within the past week.
- •Current evidence of 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.
结局指标
主要结局
Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months.
次要结局
- Long-term efficacy after twice daily treatment with FlutiForm HFA MDI over 12 months.
研究者
研究点 (28)
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