Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Decrease in oral steroid therapy requirements.
研究概览
简要总结
Trial of effects of minocycline as "add-on" therapy to adults with asthma with a history of requiring at least one episode of oral steroid therapy to control the disease.
详细描述
This is a double-blind, placebo-controlled crossover study of adult asthmatics given minocycline 150 mg po BID or placebo as add-on therapy for eight weeks each. Each eight week arm is separated by a four week wash-out. Spirometry is performed at the baseline and end of each arm. Daily symptoms scores, peak flow rates, and oral steroid requirements are recorded. A standardized asthma quality of life symptoms assessment is made every four weeks (AQLQ, Juniper).
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult asthmatics
- •History of or current use of oral steroids to control symptoms
排除标准
- •Pregnant women
研究组 & 干预措施
Minocycline
Addition of minocycline 150 mg po twice daily to current asthma treatment regimen.
干预措施: minocycline (Drug)
Placebos
Addition of placebo capsules po twice daily to current asthma treatment regimen
干预措施: Placebos (Drug)
结局指标
主要结局
Decrease in oral steroid therapy requirements.
时间窗: 8 weeks
次要结局
- improvement in morning and evening peak flow(8 weeks)
- decrease in rescue inhaler usage(8 weeks)
- improvement in spriometric parameters(8 weeks)
- improvement in symptoms scores(8 weeks)
研究者
Rauno Joks
Associate Professor of Clinical Medicine
State University of New York - Downstate Medical Center