ACTRN12620001354976尚未招募未知
Multi-centre, open-label, parallel, randomized trial to compare efficacy, tolerability and safety of tobramycin inhalation powder using Orbital™ DPI device vs TOBI Podhaler for lung infections in CF patients (Tobra Orbital TOBI Trial-TOTT)
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Inclusion criteria, which must be met at the time of study screening, are:
- •A stable history of chronic CF disease with a FEV1 of greater than or equal to 30% predicted.
- •Clinical stability, as determined by the clinician’s evaluation, with no pulmonary exacerbation in the past month determined by the patient’s records (e.g. need for IV antibiotics).
- •Proven previous tolerability to TobiPodhaler.
- •Chronic Pseudomonas aeruginosa infection as determined by the patient’s records.
- •Aged equal to or greater than 18 years
排除标准
- •Exclusion criteria are:
- •CF patients with severe unstable conditions.
- •CF patients with chronic Mycobacterium abscessus and Burkholderia cepacia complex (B. cepacia) colonisation.
- •CF patients who are on continuous tobramycin therapy (not on alternate month tobramycin therapy)
- •Pregnant or lactating females or females who intend to fall pregnant within the study period.
研究者
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