A Randomised, Double-blind, Double-dummy, Placebo Controlled (With Rescue Medication), Multicenter Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period
研究概览
简要总结
A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.
详细描述
This is a multi-center, randomized, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of Fluticasone Furoate Inhalation Powder 100mcg once daily and Fluticasone Propionate Inhalation Powder 250mcg twice daily with Placebo. Subjects will participate in the study for up to a maximum of 29 weeks (including screening, treatment and follow-up contact). The primary endpoint consists of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 week treatment period. The nominated powered secondary endpoint is the change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry and urine cortisol excretion. For subjects who have consented for pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Outpatient at least 12 years of age
- •Both genders; females of child bearing potential must be willing to use approved birth control method
- •Pre-bronchodilator FEV1 of 40-90% predicted
- •Reversibility FEV1 of at least 12% and 200mLs
- •Current asthma therapy that includes an inhaled corticosteroid for at least 4 weeks prior to first visit
排除标准
- •History of life threatening asthma
- •Respiratory infection or candidiasis
- •Asthma exacerbation within 6 months prior to first visit
- •Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
- •Allergies to study drugs, study drug excipients, medications related to study drugs
- •Taking another investigational medication or medication prohibited for use during this study
研究组 & 干预措施
Fluticasone Furoate OD and Placebo BID
Fluticasone furoate inhalation powder once daily and placebo inhalation powder twice daily for 24 weeks
干预措施: Fluticasone furoate (Drug)
Fluticasone Furoate OD and Placebo BID
Fluticasone furoate inhalation powder once daily and placebo inhalation powder twice daily for 24 weeks
干预措施: Placebo (Drug)
Fluticasone Propionate BID and Placebo OD
Fluticasone propionate inhalation powder twice daily and placebo inhalation powder once daily for 24 weeks
干预措施: Fluticasone propionate (Drug)
Fluticasone Propionate BID and Placebo OD
Fluticasone propionate inhalation powder twice daily and placebo inhalation powder once daily for 24 weeks
干预措施: Placebo (Drug)
Placebo only BID
Placebo inhalation powder twice daily for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period
时间窗: Baseline and Week 24
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the clinic visit at the end of the dosing interval. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 was measured electronically by spirometry in the evening at the Baseline through Week 24 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 24 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 post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.
次要结局
- Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period(Baseline and Week 24)
- Mean Change From Baseline in Daily Trough Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period(From Baseline up to Week 12 and Week 24)
- Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period(From Baseline up to Week 12 and Week 24)
- Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period(Baseline and Week 24)
- Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24(Baseline, Week 12, and Week 24)