NCT01381666终止2 期
Evaluation of the Diagnostic Utility of INS316 in Patients With Interstitial Lung Diseases (01-701)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 主要终点
- diagnosis of sarcoidosis using sputum induction (sputum weight)
研究概览
简要总结
The objective of the present work is to explore and compare the diagnostic quality of sputum specimens obtained by BAL, induction with hypertonic saline (3%), and induction with INS316 in patients diagnosed with interstitial lung diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18 years or older
- •undergone diagnostic bronchoalveolar lavage within the previous 21 days
- •diagnosed with sarcoidosis or other ILD
排除标准
- •having resting hypoxemia
- •receiving corticosteroid treatment
研究组 & 干预措施
hypertonic saline 3% sodium chloride solution
Placebo Comparator
inhalation via nebulizer given for 2 doses for 60 minutes each
干预措施: hypertonic saline 3% sodium chloride solution (Drug)
INS316
Experimental
inhalation via nebulizer given for 2 doses for 60 minutes each
干预措施: INS316 solution for inhalation (Drug)
结局指标
主要结局
diagnosis of sarcoidosis using sputum induction (sputum weight)
时间窗: 60 minutes
次要结局
- adverse events(60 minutes)
研究者
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