Clinical Study Evaluating Safety and Efficacy of Fluticasone Furoate in People With Asthma
2016年11月20日 更新者：GlaxoSmithKline
A Randomised, Double-blind, Placebo-controlled (With Rescue Medication), Multi-centre Study to Evaluate the Efficacy and Safety of Inhaled Fluticasone Furoate in the Treatment of Persistent Asthma in Adults and Adolescents Not Currently Receiving Inhaled Corticosteroids
A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids
研究概览
详细说明
This will be a multi-centre, randomised, placebo controlled (with rescue medication), double-blind, parallel group study.
Subjects meeting all the inclusion criteria and none of the exclusion criteria during Visit 1 (Screening Visit) will enter a two week Run-in Period.
Subjects failing screening will not be eligible for re-screening.
During the run-in and double-blind treatment periods subjects will maintain an electronic daily diary to record morning and evening peak expiratory flow (PEF), asthma symptom score and rescue albuterol/salbutamol use.
At Visit 2 (end of run-in/Randomisation Visit), subjects meeting the eligibility criteria will be randomised to either inhaled Fluticasone Furoate 50 mcg or inhaled placebo.
In addition all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as required to treat symptoms.
Subjects will attend 4 on-treatment visits at Visits 3, 4, 5, and 6 (Weeks 2, 4, 8 and 12 respectively).
Subjects will receive treatment for 84 days (12 weeks).
A follow-up contact will be performed 1-week after completing study medication (Visit 7).
Subjects will participate in the study for up to a maximum of 15 weeks (including screening, treatment and follow-up contact).
研究类型
介入性
注册 (实际的)
248
阶段
- 第三阶段
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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Klin、俄罗斯联邦、141600
- GSK Investigational Site
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Moscow、俄罗斯联邦、115446
- GSK Investigational Site
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Saratov、俄罗斯联邦、410028
- GSK Investigational Site
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St. Petersburg、俄罗斯联邦、194356
- GSK Investigational Site
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Voronezh、俄罗斯联邦、394066
- GSK Investigational Site
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Yaroslavl、俄罗斯联邦、150003
- GSK Investigational Site
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Jalisco
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Zapopan、Jalisco、墨西哥、45040
- GSK Investigational Site
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Michoacán
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Morelia、Michoacán、墨西哥、58070
- GSK Investigational Site
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Tabasco
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Villahermosa、Tabasco、墨西哥、86100
- GSK Investigational Site
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Lima、秘鲁、Lima 1
- GSK Investigational Site
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Lima、秘鲁、Lima 27
- GSK Investigational Site
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Lima
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Lima 18、Lima、秘鲁
- GSK Investigational Site
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San Borja、Lima、秘鲁、Lima 41
- GSK Investigational Site
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San Miguel、Lima、秘鲁、Lima 32
- GSK Investigational Site
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California
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Long Beach、California、美国、90808
- GSK Investigational Site
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Los Angeles、California、美国、90025
- GSK Investigational Site
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Newport Beach、California、美国、92663
- GSK Investigational Site
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Georgia
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Albany、Georgia、美国、31707
- GSK Investigational Site
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Missouri
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Columbia、Missouri、美国、65203
- GSK Investigational Site
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Oklahoma
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Oklahoma City、Oklahoma、美国、73103
- GSK Investigational Site
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South Carolina
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Orangeburg、South Carolina、美国、29118
- GSK Investigational Site
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Spartanburg、South Carolina、美国、29303
- GSK Investigational Site
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Texas
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Corsicana、Texas、美国、75110
- GSK Investigational Site
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Waco、Texas、美国、76712
- 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
12年 及以上 (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:
- Signed informed consent
- Outpatient at least 12 years of age with diagnosis of asthma at least 12 weeks before first visit
- Both genders; females of child bearing potential must be willing to use appropriate contraception during the study
- Pre-bronchodilator FEV1 of at least 60% predicted
- FEV1 reversibility of at least 12% and 200mls
- Current asthma therapy that includes a non-corticosteroid controller and/or short-acting beta agonist
Exclusion Criteria:
- History of life-threatening asthma exacerbation within the past 10 years
- Asthma exacerbation requiring treatment with oral corticosteroids within the last 3 months or that required overnight hospital stay within 6 months
- Current or recent respiratory infection or current oral candida infection
- Presence of another significant respiratory disease or medical condition that is not controlled or that could affect subject safety or study outcome
- Known or suspected allergy to study drug or materials
- Taking another investigational medication or prohibited medication during the study
- Previous treatment with inhaled fluticasone furoate in a phase II or III study
- Current smokers or former smokers with significant tobacco exposure
- Children in Care
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Fluticasone furoate 50mcg
Inhalation powder delivered by Novel Dry Powder Inhaler
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Inhalation powder delivered by Novel Dry Powder Inhaler
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安慰剂比较：Placebo
Inhalation powder delivered by Novel Dry Powder Inhaler
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Inhalation powder delivered by Novel Dry Powder Inhaler
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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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Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period
大体时间：Baseline and Week 12
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 12 clinic visit.
Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits.
The highest of 3 technically acceptable measurements was recorded.
Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 12 value minus the Baseline value.
Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.
The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.
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Baseline and Week 12
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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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Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 12-week Treatment Period
大体时间：From Baseline up to Week 12
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The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary).
A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free.
A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication.
The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant.
Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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From Baseline up to Week 12
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Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period
大体时间：From Baseline up to Week 12
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PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated.
PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use.
Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 12-week Treatment Period minus the Baseline value.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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From Baseline up to Week 12
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Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period
大体时间：From Baseline up to Week 12
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PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated.
PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use.
Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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From Baseline up to Week 12
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Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 12-week Treatment Period
大体时间：From Baseline up to Week 12
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Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement.
A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free.
A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing.
The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant.
Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value.
Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.
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From Baseline up to Week 12
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Number of Participants Who Withdrew Due to a Lack of Efficacy During the 12-week Treatment Period
大体时间：From the first dose of the study medication until Week 12/Early Withdrawal
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The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%.
The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.
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From the first dose of the study medication until Week 12/Early Withdrawal
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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.
- O'Byrne PM, Woodcock A, Bleecker ER, Bateman ED, Lotvall J, Forth R, Medley H, Jacques L, Busse WW. Efficacy and safety of once-daily fluticasone furoate 50 mcg in adults with persistent asthma: a 12-week randomized trial. Respir Res. 2014 Aug 11;15(1):88. doi: 10.1186/s12931-014-0088-z.
- Svedsater H, Jacques L, Goldfrad C, Bleecker ER. Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. NPJ Prim Care Respir Med. 2014 Jun 26;24:14019. doi: 10.1038/npjpcrm.2014.19. No abstract available.
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
2011年9月1日
初级完成 (实际的)
2012年6月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2011年9月15日
首先提交符合 QC 标准的
2011年9月15日
首次发布 (估计)
2011年9月19日
研究记录更新
最后更新发布 (估计)
2017年1月11日
上次提交的符合 QC 标准的更新
2016年11月20日
最后验证
2016年11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
- 115283
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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统计分析计划
信息标识符：115283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：115283信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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研究协议
信息标识符：115283信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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临床研究报告
信息标识符：115283信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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知情同意书
信息标识符：115283信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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个人参与者数据集
信息标识符：115283信息评论：For additional information about this study please refer to the GSK Clinical Study Register
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带注释的病例报告表
信息标识符：115283信息评论：For additional information about this study please refer to the GSK Clinical Study Register
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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.