NCT00071552终止4 期
Evaluation of Clinical Efficacy of HFA-Propelled Beclomethasone Dipropionate Metered-Dose Inhaler Versus Fluticasone Propionate Multidose Dry Powder Inhaler on Small Airways in Poorly Controlled Asthmatic Adolescent and Adult Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in post-inhalation percent-predicted FEF 25-75 (%) from baseline (week 0) to week 12
研究概览
简要总结
The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Poorly controlled asthma;
- •Average use of over 2 puffs of albuterol per day in the previous 7 days OR Having symptoms of asthma on 5 of the last 7 days OR Awakening at night due to asthma at least once in the previous 7 days OR Having been treated with a course of oral or intravenous steroids at least once in the last 3 months.
排除标准
- •Subjects receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for rhinitis;
- •Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, oral or intranasal anticholinergics;
- •History and/or presence of any non-asthmatic acute or chronic lung disease, including but not limited to bronchitis, emphysema, active tuberculosis, bronchiectasis or cystic fibrosis;
- •History and/or presence of any clinically significant cardiovascular disease, clinically significant hepatic, renal, or endocrine dysfunction, stroke, uncontrolled diabetes, hyperthyroidism, convulsive disorders, neoplastic disease other than basal cell carcinoma, and significant psychiatric disease.
研究组 & 干预措施
Qvar
Experimental
Qvar 160 mcg twice daily
干预措施: Qvar (Drug)
Flovent Diskus
Active Comparator
Flovent Diskus 200 mcg twice daily
干预措施: Flovent Diskus (Drug)
结局指标
主要结局
Change in post-inhalation percent-predicted FEF 25-75 (%) from baseline (week 0) to week 12
时间窗: Final Visit
次要结局
- Mean and mean change from pre-dose to 15-minute post-dose in percent predicted FEV1 (%) at week 12(week 12)
研究者
研究点 (1)
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