A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Treatment, Three 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 300mg as Compared to Adding Montelukast 10mg or Placebo Tablets QD to Fluticasone Propionate/Salmeterol 250/50mcg Diskus BID
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Trough (AM pre-dose and pre-rescue bronchodilator) FEV1
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily in uncontrolled asthmatic subjects > or = 18 years of age over the course of 6 weeks treatment.
The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily to fluticasone propionate/salmeterol 250/50mcg inhalation powder administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 18 years of age over the course of 6 weeks treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years of age or older
- •Non-, former or current smokers with a documented smoking history of ≤ 10 pack years
- •Asthma diagnosis as defined by the National Institutes of Health
- •Best FEV1 of 50% to <80% of the predicted normal value
- •For current and former smokers, a post-albuterol FEV1/FVC ratio of >0.70 at Visit 1/1a (between 5:00AM and 12:00 noon)
- •≥ 12% and ≥200mL reversibility of FEV1
- •Must have been using FP/SAL 250/50mcg inhalation powder BID for at least 2 weeks just prior to Visit
- •Must be able to replace their current short-acting beta2-agonists with albuterol inhalation aerosol
- •Must be able and willing to give written informed consent to take part in the study.
- •Must be able and willing to comply with all aspects of the study including completion of daily e-Diary.
- •Exclusion criteria:
- •History of life-threatening asthma
- •Recent asthma exacerbation
- •Concurrent respiratory disease
- •Recent respiratory infection
- •Liver disease
- •Other concurrent diseases/abnormalities
- •Oral candidiasis
- •Drug allergy
- •Milk protein allergy
- •Immunosuppressive Medications
- •Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1
- •OATP1B1 substrates within 4 weeks of Visit 1
- •Cytochrome P450 3A4 (CYP 3A4) Inhibitors
- •Cytochrome P450 3A4 (CYP 3A4) Inducers
- •Investigational Medications
- •Compliance: any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol
- •Affiliation with Investigator's Site
排除标准
- 未提供
研究组 & 干预措施
FP/SAL 250/50mcg BID plus placebo BID
P/SAL 250/50mcg BID plus placebo BID
干预措施: Placebo capsule (PM) (Drug)
FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
干预措施: GSK2190915 200mg QD (AM) (Drug)
FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
干预措施: FP/SAL 250/50mcg BID (Drug)
FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
干预措施: GSK2190915 100mg QD (AM) (Drug)
FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM)
干预措施: Placebo capsule (PM) (Drug)
FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
干预措施: FP/SAL 250/50mcg BID (Drug)
FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
干预措施: Montelukast 10mg QD (PM) (Drug)
FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM)
干预措施: Placebo tablets (2) (AM) (Drug)
FP/SAL 250/50mcg BID plus placebo BID
P/SAL 250/50mcg BID plus placebo BID
干预措施: FP/SAL 250/50mcg BID (Drug)
FP/SAL 250/50mcg BID plus placebo BID
P/SAL 250/50mcg BID plus placebo BID
干预措施: Placebo tablets (2) (AM) (Drug)
结局指标
主要结局
Trough (AM pre-dose and pre-rescue bronchodilator) FEV1
时间窗: at the end of the 6 week treatment period.
次要结局
- • Daily trough (AM pre-dose and pre-rescue bronchodilator) AM PEF(averaged over the last 3 weeks of the 6 week treatment period.)
- • Daily PM PEF(averaged over the last 3 weeks of the 6 week treatment period.)
- • Percentage of symptom-free days(during the last 3 weeks of the 6 week treatment period.)
- • Percentage of nights without awakenings due to asthma(during the last 3 weeks of the 6 week treatment period.)
- • Proportion of subjects withdrawn due to lack of efficacy(during the last 3 weeks of the 6 week treatment period.)
- • Daily (average of AM and PM)(averaged over the last 3 weeks of the 6 week treatment period)
- • Daily asthma symptom score(averaged over the last 3 weeks of the 6 week treatment period.)
- • Daily rescue salbutamol use(averaged over the last 3 weeks of the 6 week treatment period.)
- • Percentage of rescue-free days(during the last 3 weeks of the 6 week treatment period.)
- • Percentage of symptom-free nights(during the last 3 weeks of the 6 week treatment period.)
- • Percentage of rescue-free nights(during the last 3 weeks of the 6 week treatment period.)