NCT01057927已完成2 期
Parallel Group, Randomised, Placebo Controlled, Double Blind Oral Assessment of OC000459 Dosed Twice Daily for 28 Days in Asthmatic Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Oxagen Ltd
- 入组人数
- 132
- 试验地点
- 15
- 主要终点
- Forced expiratory volume in one second (FEV1)
研究概览
简要总结
The purpose of the study is to investigate the clinical effects of multiple (28 day) twice-daily doses of OC000459 in comparison to placebo on clinic lung function (FEV1) in mild to moderate asthmatics with an FEV1 of 60-80% of predicted and requiring only short acting inhaled B2-adrenergic agonists for symptomatic control.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Use of inhaled or local corticosteroids in the period from 28 days prior to screening.
- •Receipt of prescribed or over the counter medication within 14 days of the first study day.
研究组 & 干预措施
OC000459
Experimental
干预措施: OC000459 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Forced expiratory volume in one second (FEV1)
时间窗: 28 days
次要结局
- Clinic peak expiratory flow, diary peak expiratory flow, diary asthma symptoms, diary salbutamol use, Asthma Quality of Life Questionnaire (AQLQ(S))(28 days)
- Sputum eosinophilia (subset of patients) and serum IgE(28 days)
- Safety and tolerability assessed by adverse events, chest examination, concomitant medication and laboratory safety parameters(28 days)
研究者
研究点 (15)
Loading locations...
相似试验
已完成
2 期
Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa.BronchiectasisNCT00775138Insmed Incorporated64
已完成
1 期
Safety, Efficacy, and Pharmacokinetics (PK) Study of Trans Sodium Crocetinate (TSC) in Patients With Intermittent ClaudicationIntermittent ClaudicationNCT00725881Diffusion Pharmaceuticals Inc48
已完成
2 期
Dose Range Finding Study of Bimagrumab in SarcopeniaSarcopeniaNCT02333331Novartis Pharmaceuticals217
已完成
3 期
Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive BladderUrinary Bladder, OveractiveNCT00688688Astellas Pharma Inc2,792
Unknown
2 期
SP01A: The Study of an Oral Entry Inhibitor in Treatment-Experienced HIV PatientsHIV InfectionsHuman Immunodeficiency VirusNCT00299897Samaritan Pharmaceuticals, Inc60