NL-OMON30795招募中3 期
Bronchiectasis and long term Azithromycin (AZM) Treatment: a randomised placebo-controlled trial studying disease modifying effects of immunomodulating treatment - The BAT trial: AZM versus placebo in bronchiectasis
Medisch Centrum Alkmaar0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients aged 18 >= years
- •Bronchiectasis diagnosed by plain bronchography or high resolution computer tomography.
- •Minimal 4 lower respiratory tract infection (LRTI) treated with oral/IV antibiotics in the year preceeding the study inclusion.
- •The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum.
- •Three sputum cultures with either P.aeruginosa or H. influenzae in the preceeding year.
- •Informed consent.
排除标准
- •Previous ( >= 6 weeks) prolonged macrolide therapy.
- •Pregnant or lactating women.
- •Allergy to macrolides.
- •Intolerance to macrolides.
- •Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or
- •more times the upper limit of normal).
- •Use of antibiotics within 14 days of screening.
- •Use of orale or IV corticosteroids (>= 30 mg prednisolone/daily) within 30 days
- •of screening.
- •Initiation of tobramycin/colimycin solution for inhalation, recombinant
- •human DNAase inhalation solution, or high dose ibuprofen within 30 dagen
- •of screening.
- •Other research medication started 2 months prior to inclusion.
研究者
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