NCT05658029撤回1 期
An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in Patients With a Tracheostomy
Matthew Bruehl1 个研究点 分布在 1 个国家开始时间: 2023年5月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Incidence of adverse events / serious adverse events
研究概览
简要总结
The goal of this investigator-initiated, open label study is to evaluate the safety and efficacy of ARINA-1 in people with a tracheostomy.
Participants will attend study visits at Screening, Baseline, Day 14, Day 28, and Day 56. There will be 3 safety phone calls at Days 2, 7, and 21. Participants will nebulize the ARINA-1 solution twice daily for 28 days
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tracheostomy for ≥6 months with no anticipated changes to tracheostomy status within the next 3 months from screening visit
- •Males or females 18-75 years old at time of consent
- •Willing and able to comply with the protocol and visit schedule
- •Subject or legal authorized representative capable of giving informed consent. Determination of subject capacity to give informed consent will be determined by investigators and guided by principles set forth in the Declaration of Helsinki (World Medical Association, 2013) and by WakeMed Health & Hospitals guidance (Patient Competency and Decisional Capacity - Legal Affairs Tip Sheet/FAQ).
排除标准
- •Inability to speak or understand English
- •Positive urine pregnancy test at screening and/or baseline visit, if applicable
- •Active breastfeeding status
- •Diagnosis of cystic fibrosis or primary ciliary dyskinesia
- •History of lung transplant
- •Listed for lung transplant
- •Inability to tolerate nebulized treatments
- •Planned decannulation before completion of this study
- •Exacerbation or infections requiring any acute antibiotics, urgent care visit, emergency department visit or hospitalization within 14 days of screening visit
- •Previous intolerance to hypertonic saline (HTS)
- •Initiating a chronic azithromycin or any new inhaled maintenance therapy < 28 days prior to baseline visit
- •Initiating any N-acetyl-cysteine-containing (NAC), ascorbic acid or glutathione (GSH)-containing therapy (oral or nebulized) < 28 days prior to baseline visit
- •Intolerance to NAC or GSH
- •Intolerance to bronchodilator (e.g., Albuterol)
- •Significant comorbidities that in the opinion of the investigator would reduce the safety of the subject or interfere with the ability to interpret study data
- •Currently participating in or have participated in other interventional (drug or device) clinical study within 90 days of the baseline visit
- •Receiving a vaccination within 14 days of the baseline visit
研究组 & 干预措施
Open label treatment group
Experimental
干预措施: ARINA-1 (Drug)
结局指标
主要结局
Incidence of adverse events / serious adverse events
时间窗: Baseline to day 28
次要结局
- Change from baseline to day 28 for Composite Tracheostomy Questionnaire and the Clinical Global Impression of Change (CGI-C)(Baseline to day 28)
- Changes in blood CRP over 28 days(Baseline to day 28)
- Ventilator settings / respiratory system compliance (for subjects on intermittent chronic ventilatory support)(Baseline to day 28)
- Change in bacterial culture at 28 days(Baseline to day 28)
- Change in mucus rheology(Baseline to day 28)
- Peripheral Oxygen Saturation (SpO2)(Baseline to day 28)
研究者
Matthew Bruehl
M.D.
WakeMed Health and Hospitals
研究点 (1)
Loading locations...
相似试验
招募中
早期 1 期
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous CD-801 in Treating Advanced HCC PatientsAdvanced Hepatocellular CarcinomaNCT06418659Shanghai Changzheng Hospital37
招募中
早期 1 期
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α srRNA in Treating Advanced ICC PatientsIntrahepatic CholangiocarcinomaNCT06583993Shanghai Changzheng Hospital9
Unknown
不适用
An Investigator Initiated Study for OTOV101N+OTOV101C InjectionDFNB9NCT05901480Otovia Therapeutics25
已完成
3 期
CONCERTA (OROS Methylphenidate Hydrochloride) for the Treatment of Attention Deficit Hyperactivity Disorder in AdultsAttention Deficit Disorder With HyperactivityNCT00246207Janssen-Ortho Inc., Canada32
招募中
1 期
Assessment of Safety, Tolerability and Pharmacokinetics With BAT8010 for Injection in Advanced Malignant Solid Tumors PatientsAdvanced or Metastatic Solid TumorsNCT05848466Bio-Thera Solutions109