An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria, Burkholderia Spp, Aspergillus Spp and Corona-like Viral (Sub-Study) Infections
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects
研究概览
简要总结
Non tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current treatment. These patients have few options to treat their lung infection. Nitric oxide has broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp, Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with difficult lung infections. This study will provide more data to see if NO therapy can reduce the bacterial load in the lungs, help the patients breath better; and in the case of COVID-19 act as a anti-viral agent resulting in the reduction of incidence of oxygen therapy, mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation during the study period.
详细描述
Main Study
Primary Objective: Assess the safety of inhaled NO (gNO) in adults & adolescents with NTM, Burkholderia, Aspergillus Lung Infections and Viral Lung (COVID-19) Infections
Safety will be evaluated by unanticipated adverse events in clinical labs (hematology, coagulation, and serum chemistries); in vitals; in inspired concentration of NO, O2 and NO2 delivered to each subject and; in real time methemoglobin and oxygen saturation levels.
Primary Endpoint:
Determine the safety of gNO in the NTM population,
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Has been previously diagnosed with NTM, Burkholderia spp and Aspergillus spp. or Corona-like viral infection:
- •NTM, Burkholderia spp and Aspergillus spp defined as positive culture(s) of at least one species of Mycobacterium avium Complex (MAC) or Mycobacterium abscessus Complex (MABSCor Burkholderia spp and Aspergillus spp) or Corona-like viral infection:
- •History of repeatedly positive cultures (2 or more), irregardless of therapy
- •Male or female ≥14 years of age.
- •Female not pregnant at time of study.
- •Has an FEV1 ≥ 30 % of predicted. c. Suspected corona-like viral infection
- •Oxygen saturation on room air >92% at screening.
- •a. Able to breathe without supplemental oxygen for 60 minutes
- •Non-smoker for at least 6 months prior to screening and agrees not to smoke during the study.
- •Willing and able to comply with the treatment schedule and procedures.
排除标准
- •Use of an investigational drug within 30 days of screening
- •History of frequent epistaxis (>1 episode/month)
- •Significant hemoptysis within 30 days (≥ 5 mL of blood in one coughing episode or > 30 mL of blood in a 24 hour period)
- •History of reactive pulmonary vascular hypertension
- •Methemoglobin >3% at screening
- •Liver function insufficiency (ALT/ AST >3 of normal values)
- •Hemoglobin <11 g/dl
- •Thrombocytopenia (platelet count <100,000/mm3) at screening
- •Prothrombin time international ratio (INR) > 1.3 at screening
- •Changes to antibiotics (e.g. azithromycin) from 7 days prior to screening through last treatment day. (Subjects may be taking antibiotics or antivirals during this time period, but they cannot start, stop or change doses during this time period)
- •On supplemental oxygen during gNO treatment (SaO2 < 90% for 50 minutes while resting in a chair).
- •For women of child bearing potential:
- •positive pregnancy test at screening or
- •lactating or
- •unwilling to practice a medically acceptable form of contraception from screening to Day 36 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent)
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
研究组 & 干预措施
160 ppm Nitric Oxide
干预措施: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation (Drug)
结局指标
主要结局
Measure the safety of 160ppm inhaled nitric oxide delivery in NTM subjects
时间窗: 26 Days
Measure the number of unanticipated adverse events over the duration of the study protocol
次要结局
- Measure the effect of 160ppm inhaled nitric oxide on Quality of Life (CRISS) Score(Day 19 and 26)
- Measure the effect of 160ppm inhaled nitric oxide delivery on lung spirometry in NTM subjects(Day 5,12,19 and 26)
- Measure the antimicrobial effect of 160ppm inhaled nitric oxide on lung NTM bacterial load in the sputum(Day 19 and 26)
研究者
Chris Miller
CSO
Nitric Solutions Inc.