A Phase I, Single-Blinded, Randomized Study of Nebulized RNS60 in Combination With Budesonide in Adult Subjects With Mild to Moderate Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Change in Forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
The purpose of this study is to determine whether RNS60, in combination with budesonide, is safe in mild to moderate asthmatics when taken by nebulization over a 28-day period, compared to a 28-day control period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female non-smokers, aged between 18 and 65 years.
- •Clinical diagnosis of mild to moderate asthma meeting NHLBI 2007 guidelines as outlined in Appendix A.
- •Subjects who have a currently prescribed inhaled corticosteroid medication to treat asthma, alone or in combination with other medications, with usage of 1 month (≥ 95% compliance) or more on the inhaled corticosteroid treatment.
- •Normal 12-lead ECG at Screening.
- •Normal single view chest x-ray at Screening.
- •Men and women of reproductive potential who commit to use adequate contraception during the study and for 1 month following the last day of treatment (Day 57).
- •Women of childbearing potential who have a negative pregnancy test (serum HCG) at the time of study entry, and again on Day
- •Subjects, or their legal guardians, must be capable of understanding the purpose and risks of the study and provide written, voluntary, informed consent.
排除标准
- •Chronic or acute disease that might interfere with the evaluation of RNS
- •Pregnancy, intent to become pregnant, or breastfeeding.
- •Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated).
- •Positive viral serology test for Human Immunodeficiency Virus (HIV-1), HBsAG and Hepatitis C antibody.
- •Positive urine drug screen (UDS) for drugs of abuse including alcohol and cotinine at the time of study entry and again on Day
- •Infections that require intravenous antibiotic therapy.
- •Significant organ dysfunction, including cardiac, renal, liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry.
- •Treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry.
- •Treatment with any investigational drugs, therapies, or medical devices within 4 weeks prior to study entry.
- •Any use of antidepressants or other psychiatric medicine within 4 weeks prior to study entry and/or during the study treatment period.
- •Use of any over-the-counter asthma treatments, including Primatene Mist, during the 8-week active study period.
研究组 & 干预措施
RNS60-BD 0.25
RNS60 in combination with Budesonide 0.25mg/2ml concentration
干预措施: RNS60 (Drug)
RNS60-BD 0.25
RNS60 in combination with Budesonide 0.25mg/2ml concentration
干预措施: Budesonide (Drug)
RNS60-BD 0.5
RNS60 in combination with Budesonide 0.5mg/2ml concentration
干预措施: RNS60 (Drug)
RNS60-BD 0.5
RNS60 in combination with Budesonide 0.5mg/2ml concentration
干预措施: Budesonide (Drug)
NS-BD 0.5
Normal Saline control (NS) in combination with Budesonide 0.5mg/2ml concentration
干预措施: Normal Saline (Drug)
NS-BD 0.5
Normal Saline control (NS) in combination with Budesonide 0.5mg/2ml concentration
干预措施: Budesonide (Drug)
结局指标
主要结局
Change in Forced expiratory volume in 1 second (FEV1)
时间窗: Baseline to 56 days
Evidence that RNS60 in combination with budesonide does not cause bronchoconstriction, as measured by FEV1 scores.
次要结局
- Change in peak expiratory flow(Baseline to 56 days)
- Change in quality of life(56 days)
- Change in rescue inhaler usage(56 days)