NCT02382510已完成2 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Two-Way Cross-Over, Phase 2a Study to Evaluate the Safety and Bronchodilator Activity of TRN-157 in Stable Mild and Moderate Asthmatics
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
- 59
- 试验地点
- 6
- 主要终点
- Change from baseline in FEV1
研究概览
简要总结
This multiple ascending dose study is to determine the safety and bronchodilator activity of TRN-157 in 59 mild and moderate asthmatics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the following criteria will be considered eligible to participate in the study:
- •The patient is ≥ 18 and < 70 years of age, and gives informed consent
- •Clinical diagnosis of mild to moderate asthma of at least 6 months duration and age of onset < 50 years
- •Presently using ICS at moderate doses (equivalent to 200-800 µg of budesonide or 88-500 µg of fluticasone daily)
- •≥ 12% and ≥ 200 mL improvement in FEV1 to 4 puffs albuterol by metered-dose inhaler (MDI) at screening visit
- •Patient is willing to use acceptable form of birth control during trial and for one month thereafter
- •Ability to measure morning (AM) peak expiratory flow (PEF) on schedule using electronic peak flow meter (EPFM) and to complete the study diary correctly at least 70% of the time during the run-in period
- •After 7 day withdrawal from LABA therapy and overnight withdrawal from SABA therapy (except rescue medication), patient has between 55% - 80% of predicted FEV1 at CV2
排除标准
- •A patient meeting any of the following criteria is not eligible for enrollment in the study:
- •A clinical diagnosis of chronic obstructive pulmonary disease (COPD), chronic bronchitis, bronchiectasis, or other significant pulmonary disease other than asthma
- •History of upper or lower respiratory infection within 4 weeks of screening
- •History of asthma exacerbation requiring oral or systemic corticosteroids or hospital admission within 6 months of screening
- •History of myocardial infarction, or cardiac conduction abnormalities, including but not limited to atrial fibrillation, and paroxysmal atrial tachycardia
- •Hospitalization due to cardiac failure within the last 6 months
- •History of narrow angle glaucoma or obstructive uropathy
- •Current smokers or vapers, or former smokers with > 10 pack-year (self-reported) history of smoking
- •Patients who presently use the following medications will not be eligible for participation:
- •Long-acting muscarinic receptor antagonist (LAMA)
- •LABA (but may be withdrawn and converted to SABA x 7 days prior to entry)
- •Leukotriene pathway blockers
- •Anti-IgE antibody (Xolair) within last 6 months prior to CV1
- •Phosphodiesterase 4 (PDE4) inhibitors (e.g., Roflumilast)
- •Methylxanthines (e.g., aminophylline and theophylline)
- •5-Lipoxygenase inhibitor (e.g., Zileuton)
- •Allergies to LAMA therapies
- •History of life-threatening asthma exacerbation requiring ICU admission, mechanical ventilation, or tracheostomy
研究组 & 干预措施
TRN-157
Experimental
干预措施: TRN-157 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Tiotropium
Active Comparator
干预措施: Tiotropium (Drug)
结局指标
主要结局
Change from baseline in FEV1
时间窗: After 2 weeks of treatment with TRN-157 vs. Placebo
Safety and tolerability as determined by number of subjects with adverse events
时间窗: After 2 weeks of treatment with TRN-157 vs. Placebo
Adverse events and/or clinically significant changes in vital signs, ECG, and/or laboratory values
次要结局
- Characterize effects on asthma symptomatology(During the 2 weeks of treatment with TRN-157 vs. Placebo)
- Characterize effects on pulmonary function(After 2 weeks of treatment with TRN-157 vs. Placebo)
- Determination of pharmacokinetic parameters: AUC0-t, AUC0-inf, Cmax, tmax, t½, elimination rate constant (kel), volume of distribution at steady state (Vss/F), total plasma clearance (CL/F)(After 2 weeks of treatment with TRN-157)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
1 期
Single Ascending Dose Study of TRN-157 in Healthy SubjectsChronic Obstructive Pulmonary DiseaseNCT02133339Theron Pharmaceuticals, Inc.30
已完成
2 期
Bronchodilator Effects and Safety of Glycopyrronium Bromide (25 ug and 50 ug o.d.) in AsthmaAsthmaNCT03137784Novartis Pharmaceuticals148
招募中
2 期
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With AsthmaAsthmaNCT05222529Novartis Pharmaceuticals42
已完成
3 期
Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPDEmphysemaChronic Obstructive Pulmonary DiseaseChronic BronchitisNCT00064402Sumitomo Pharma America, Inc.741
已完成
1 期
Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's DiseaseParkinson's DiseaseNCT02157714Prothena Biosciences Limited64