A Study of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.
2016年9月13日 更新者：GlaxoSmithKline
A Randomised, Double-blind, Double Dummy, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening All Administered by Inhalation Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.
The purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once daily either in the morning or the evening and GW685698X 250mcg administered once daily in the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
669
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kazan、俄罗斯联邦、420015
- GSK Investigational Site
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Moscow、俄罗斯联邦、115446
- GSK Investigational Site
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Moscow、俄罗斯联邦、115478
- GSK Investigational Site
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Moscow、俄罗斯联邦、123 182
- GSK Investigational Site
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St. Petersburg、俄罗斯联邦、197022
- GSK Investigational Site
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St. Petersburg、俄罗斯联邦、197 089
- GSK Investigational Site
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Tomsk、俄罗斯联邦、634 050
- GSK Investigational Site
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Volgograd、俄罗斯联邦、400130
- GSK Investigational Site
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Pleven、保加利亚、5800
- GSK Investigational Site
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Sofia、保加利亚、1606
- GSK Investigational Site
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Sofia、保加利亚、1431/1000
- GSK Investigational Site
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Sofia、保加利亚、1619
- GSK Investigational Site
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Varna、保加利亚、9010
- GSK Investigational Site
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Osijek、克罗地亚、31000
- GSK Investigational Site
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Split、克罗地亚、21000
- GSK Investigational Site
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Zagreb、克罗地亚、10000
- GSK Investigational Site
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Törökbálint、匈牙利、2045
- GSK Investigational Site
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Bloemfontein、南非、9300
- GSK Investigational Site
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Cape Town、南非、7500
- GSK Investigational Site
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Mexico、墨西哥、04530
- GSK Investigational Site
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Mexico, D.F.、墨西哥、06720
- GSK Investigational Site
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Rio Grande Do Sul
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Porto Alegre、Rio Grande Do Sul、巴西、40110-160
- GSK Investigational Site
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Athens、希腊、115 28
- GSK Investigational Site
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Athens、希腊、15669
- GSK Investigational Site
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Papagos/Athens、希腊、15669
- GSK Investigational Site
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Berlin、德国、13086
- GSK Investigational Site
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Berlin、德国、10717
- GSK Investigational Site
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Berlin、德国、13597
- GSK Investigational Site
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Berlin、德国、10969
- GSK Investigational Site
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Berlin、德国、10365
- GSK Investigational Site
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Berlin、德国、10585
- GSK Investigational Site
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Baden-Wuerttemberg
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Schwetzingen、Baden-Wuerttemberg、德国、68723
- GSK Investigational Site
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Weinheim、Baden-Wuerttemberg、德国、69469
- GSK Investigational Site
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Hessen
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Eschwege、Hessen、德国、37269
- GSK Investigational Site
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Gelnhausen、Hessen、德国、63571
- GSK Investigational Site
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Kassel、Hessen、德国、34117
- GSK Investigational Site
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Niedersachsen
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Hannover、Niedersachsen、德国、30159
- GSK Investigational Site
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Hannover、Niedersachsen、德国、30167
- GSK Investigational Site
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Lueneburg、Niedersachsen、德国、21335
- GSK Investigational Site
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Nordrhein-Westfalen
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Guetersloh、Nordrhein-Westfalen、德国、33330
- GSK Investigational Site
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Sachsen
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Annaberg、Sachsen、德国、09456
- GSK Investigational Site
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Aue、Sachsen、德国、08280
- GSK Investigational Site
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Schleswig-Holstein
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Geesthacht、Schleswig-Holstein、德国、21502
- GSK Investigational Site
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Thueringen
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Erfurt、Thueringen、德国、99084
- GSK Investigational Site
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Campania
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Eboli (SA)、Campania、意大利、84025
- GSK Investigational Site
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Napoli、Campania、意大利、80131
- GSK Investigational Site
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Salerno、Campania、意大利、84126
- GSK Investigational Site
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Emilia-Romagna
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Ferrara、Emilia-Romagna、意大利、44100
- GSK Investigational Site
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Liguria
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Genova、Liguria、意大利、16132
- GSK Investigational Site
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Lombardia
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Sesto San Giovanni (MI)、Lombardia、意大利、20099
- GSK Investigational Site
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Marche
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Torrette (AN)、Marche、意大利、60126
- GSK Investigational Site
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Toscana
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Firenze、Toscana、意大利、50134
- GSK Investigational Site
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Pisa、Toscana、意大利、56124
- GSK Investigational Site
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Veneto
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Bussolengo (VR)、Veneto、意大利、37012
- GSK Investigational Site
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Padova、Veneto、意大利、35128
- GSK Investigational Site
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Región Metro De Santiago
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Santiago、Región Metro De Santiago、智利、7500551
- GSK Investigational Site
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Santiago、Región Metro De Santiago、智利、7500691
- GSK Investigational Site
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Kohtal-Jdrve、爱沙尼亚、31 025
- GSK Investigational Site
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Parnu、爱沙尼亚、80024
- GSK Investigational Site
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Tallinn、爱沙尼亚、1162
- GSK Investigational Site
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Tartu、爱沙尼亚、51014
- GSK Investigational Site
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Brasov、罗马尼亚
- GSK Investigational Site
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Bucharest、罗马尼亚、050159
- GSK Investigational Site
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Bucuresti、罗马尼亚、70000
- GSK Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 至 65年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Outpatients aged between 16- 65 years.
- Male and female; female subjects must be non-child bearing potential or of childbearing potenetial with negative pregnancy test and willing to use acceptable contraceptive methods
- Documented clinical history of persistent asthma first diagnosed at least 6 months prior to Visit 1
- Currently receiving inhaled short-acting beta-2 agonists for symptom relief
- A lung function of between 50 to 90% predicted (PEF)
- Increase in PEF of at least15%, 20 minutes after inhalation of 400mcg salbutamol
Exclusion Criteria:
- History of respiratory tract infection and/or exacerbation of asthma within a period of 4 weeks prior to Visit 1
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures.
- A history of two or more asthma exacerbations requiring treatment with oral corticosteroids or hospitalisation in the 6 months before Visit 1.
- Past or present disease that, as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematologic disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis and bronchopulmonary dysplasia).
- Known or suspected sensitivity to corticosteroids, VENTOLIN, or the constituents of ROTADISKS (e.g., lactose).
- Undergoing allergen desensitisation therapy.
- Neurological or psychiatric disease or history of drug or alcohol abuse that would interfere with the subject's proper completion of the protocol requirements.
- Is a current smoker or has a smoking history of 10 pack years or more (e.g., 20 cigarettes/day for 10 years). Note: Current smoker is defined as currently smoking or stopped smoking within 6 months of screening visit.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：安慰剂
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GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
Placebo inhaled twice daily (morning and evening) for 28 days
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实验性的：GW685698X (fluticasone furoate) 100mcg Morning
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GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
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实验性的：GW685698X (fluticasone furoate) 100mcg Evening
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GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
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实验性的：GW685698X (fluticasone furoate) 250mcg Evening
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GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Peak expiratory flow (PEF)
大体时间：28 days
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Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning compared with GW685698X 100mcg once daily in the evening by inhalation via DISKHALER.
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28 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Peak expiratory flow (PEF)
大体时间：28 days
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Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 250mcg once daily compared with GW685698X 100mcg once daily both administered in the evening by inhalation via DISKHALER.
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28 days
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PEF
大体时间：28 days
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Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning, 100mcg once daily in the evening, or GW685698X 250mcg once daily in the evening, compared with placebo
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28 days
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Clinic lung function
大体时间：28 days
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Change from baseline in pre bronchodilator clinic lung function (forced expiratory volume in 1 second [FEV1] and PEF) after 28 days of treatment with GW685698X 250mcg once daily in the evening compared with GW685698X 100mcg once daily in the evening
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28 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.
- Medley H, Orozco S, Allen A. Efficacy and safety profile of fluticasone furoate administered once daily in the morning or evening: a randomized, double-blind, double-dummy, placebo-controlled trial in adult and adolescent patients with persistent bronchial asthma. Clin Ther. 2012 Aug;34(8):1683-95. doi: 10.1016/j.clinthera.2012.06.024. Epub 2012 Jul 13.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2003年9月1日
初级完成 (实际的)
2004年3月1日
研究完成 (实际的)
2004年3月1日
研究注册日期
首次提交
2011年12月8日
首先提交符合 QC 标准的
2011年12月21日
首次发布 (估计)
2011年12月26日
研究记录更新
最后更新发布 (估计)
2016年9月15日
上次提交的符合 QC 标准的更新
2016年9月13日
最后验证
2016年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- FFA20001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
研究数据/文件
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带注释的病例报告表
信息标识符：FFA20001信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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数据集规范
信息标识符：FFA20001信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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统计分析计划
信息标识符：FFA20001信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
知情同意书
信息标识符：FFA20001信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
临床研究报告
信息标识符：FFA20001信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
个人参与者数据集
信息标识符：FFA20001信息评论：For additional information about this study please refer to the GSK Clinical Study Register
-
研究协议
信息标识符：FFA20001信息评论：For additional information about this study please refer to the GSK Clinical Study Register
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.