NCT04685720已完成不适用
A Pilot Study to Assess the Effect of Intermittent Inhaled Nitric Oxide on the Treatment of Nontuberculous Mycobacteria (NTM) Lung Infection in Cystic Fibrosis and Non-Cystic Fibrosis Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Treatment-Emergent SAEs
研究概览
简要总结
The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.
详细描述
The study will include 20 patients from up to four clinical sites in Australia. The overall treatment plan includes 2 weeks of inhalation treatments (intensive phase) of iNO four times per day at 4.5-hour intervals followed by 10 weeks of inhalation treatments (maintenance phase) at the maximum tolerated dose (a maximum of 250 ppm NO) inhaled twice daily.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with refractory NTM (MAC or MAbs) pulmonary infection
- •CF and Non-CF patients
排除标准
- •Diagnosis of methemoglobinemia or MetHb ≥2% at screening; treatment with any drug known to increase MetHb; known or suspected hemoglobinopathy.
- •History of or current myeloproliferative disease, leukemia or other hematological malignancy; known or suspected immunodeficiency disease.
- •Subjects with advanced cardiovascular disease or CHF
- •Use of an investigational drug during the 30 days prior to enrollment.
- •History of frequent epistaxis (>1 episode/month); significant hemoptysis (during the 30 days prior to enrollment.
- •Subject on non-constant dose of systemic steroids within 30 days prior to enrollment; subjects on constant systemic steroids if the daily dose is higher than 10 mg/d prednisolone or equivalent.
- •Active pulmonary malignancy (primary or metastatic) or any malignancy; history of lung transplantation.
- •Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening.
- •Uncontrolled hypertension within 3 months prior to or at screening
- •Diagnosis of significant pulmonary hypertension indicated on echocardiogram at screening
- •Clinically significant renal or liver laboratory abnormalities
- •History of daily, continuous oxygen supplementation.
- •Women of childbearing potential - pregnant or breastfeeding, or not on medically acceptable double methods of contraception from enrollment until Day
- •Smoking tobacco or any substance within 6 months prior to screening or anticipated inability to refrain from smoking throughout the study.
- •Patient receiving drugs that have a contraindication with NO
结局指标
主要结局
Treatment-Emergent SAEs
时间窗: Day 1 to Day 84
The primary endpoint of the study is the number of patients with treatment-emergent SAEs
次要结局
- Changes in NTM bacterial load from baseline to Day 174(Day 1 to Day 174)
- Changes in FEV1 from baseline to Day 174(Day 1 to Day 174)
- Change in 6 Minute Walking Test(Day 1 to Day 84)
- Number of patients with culture conversion at Day 174(Day 1 to Day 174)
- Changes in quality of life assessed by CFQ-R for or QOL-B with NTM module(Day 1 to Day 174)
- Changes in activity tracker data as assessed by changes in distance from baseline to Day 174.(Day 1 to Day 174)
研究者
研究点 (2)
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