Open-Label Trial of the Use 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
- 14
- 试验地点
- 1
- 主要终点
- Improvement in FEV1 on spirometry
研究概览
简要总结
The tetracycline minocycline has, in addition to its anti-infective properties, anti-inflammatory properties which may be of use in the treatment of asthma. This study evaluates the benefit of minocycline as add-on therapy for adults with asthma.
详细描述
Adult asthmatic (ages 18 to 75 years) with a history of moderate to severe persistent asthma are given minocycline capsules as add-on therapy for treatment of asthma. Treatment is for one year. Dosing begins at 150 mg twice daily and can increase every eight weeks by 50mg BID to a maximum of 250 mg twice daily. This is as per patient tolerance as minocycline can cause dizziness and stomach upset, as well as effects of liver enzymes.Patients undergo routine blood toxicity screens every two months, at which time spirometry is performed Exclusion criteria: pregnant women (adequate contraception in mandated) previous history of hypersensitivity to tetracyclines, chronic liver disease Outcome measures: improvement in FEV1 and other spirometric parameters, decrease in oral steroid requirements, change in total serum IgE, improvement in quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults (ages 18 to 75 yrs)
- •Mild to severe asthma
- •History of or current oral steroid use to control asthma atopy
排除标准
- •Pregnant women
研究组 & 干预措施
minocycline
addition of minocycline to standard asthma care as add-on therapy: 150 mg bid to 250 mg bid for up to one year
干预措施: Minocycline (Drug)
结局指标
主要结局
Improvement in FEV1 on spirometry
时间窗: one year
次要结局
- decrease in oral steroid requirements(one year)
- improvement in quality of life scores(one year)
- decrease in total serum IgE(one year)
研究者
Rauno Joks, MD
Associate Professor of Clinical Medicine
State University of New York - Downstate Medical Center