NCT03208764已完成2 期
A Prospective, Open Labeled, Multi-Center, Evaluation of the Efficacy Safety and Tolerability of Nitric Oxide Given Intermittently Via Inhalation to Subjects With NTM (Specifically MABSC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety measured by NO-related Serious Adverse Events
研究概览
简要总结
A Prospective, Open labeled, multi-Center, Evaluation of the Efficacy Safety and Tolerability of Nitric Oxide Given Intermittently via Inhalation to Subjects with NTM (specifically MABSC)
Nitric Oxide (NO) has been shown to play a critical role in various biological functions. In the airways, NO is considered to play a key role in the innate immune system in which the first-line of host defense against microbes is built.
In vitro studies suggested that NO, in part per million (ppm) concentrations, possesses anti-microbial activity against a wide variety of phyla including fungi, and antibiotic-resistance bacteria.
In this study the investigators wish to evaluate the efficacy, safety and tolerability of 160 ppm Nitric Oxide intermittently delivered via inhalation to subjects infected with Non-tuberculosis mycobacteria (NTM), specifically with MABSC.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects (Male or female) between 6 to 65 years old
- •Diagnosis of pulmonary non-tuberculosis mycobacterial lung disease in accordance with the 2007 ATS/IDSA criteria with evidence of nodular bronchiectasis and/or cavitary disease by chest computed tomography (CT) and by culture.
- •History of at least 6 months chronic infection with Mycobacterium abscessus.
- •Mycobacterium abscessus positive sputum sample at screening or prior to screening.
- •Receiving ATS/IDSA guidelines-based treatment regimen defined as: adherent to a multi-drug regimen for at least 6 months prior to screening with persistently positive mycobacterial abscessus cultures.
- •FEV1 ≥ 30% at screening as well as baseline.
- •Ability to produce sputum or be willing to undergo an induction of sputum for clinical evaluation.
- •Life expectancy ≥1 year
- •Ability to perform 6MWT, but not to exceed a distance of 700 meters during screening.
- •Ability to understand and comply with study requirements.
- •Approved and signed informed consent by subject and/or by parent/legal guardian (depending on subject's age).
排除标准
- •Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
- •Subjects diagnosed with methemoglobinemia, immunodeficiency, heart disease, pulmonary hypertension and/or high blood pressure.
- •Use of an investigational drug during the last 30 days prior enrollment and/or the subject is expected to participate in a new study within five months from enrollment to this study.
- •History of frequent epistaxis (>1 episode/month).
- •Significant hemoptysis during the last 30 days prior to enrolment (>30 Ml of blood in a 24-hour period).
- •Methemoglobin level >2% at screening.
- •Patients on inconsistant dosage of systemic steroids (any formulation) 30 days prior to enrolment.
- •History of illicit drug or medication abuse within 1 year of screening.
- •History of lung transplantation.
- •History of daily, continuous oxygen supplementation.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
- •Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening.
- •Any change in chronic NTM multi-drug regimen within 28 days prior to study day 1.
研究组 & 干预措施
Nitric Oxide treatment
Experimental
干预措施: Nitric Oxide (Drug)
结局指标
主要结局
Safety measured by NO-related Serious Adverse Events
时间窗: 21 days
次要结局
- Six minute walk test(21 days)
- Mycobacterium Abscesuss load in sputum(81 days)
- NO-related AE's such as elevation of methemoglobin and elevation of NO2 during treatment(21 days)
- Type and frequency of occurrence of NO-related Adverse Events (AE's) and Serious AE's (SAE's)(51 days)
研究者
研究点 (1)
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