EUCTR2010-019466-81-Outside-EU/EEA进行中（未招募）1 期
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Treatment, Four 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 100 mg, GSK2190915 300 mg, Montelukast 10 mg or Placebo Tablets Once Daily or Salmeterol 50 mcg Inhalation Powder Twice Daily to Fluticasone Propionate 100 mcg Inhalation Powder Twice Daily in Uncontrolled Asthmatic Subjects =12 Years of Age.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age: 12 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
- •- 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 100mcg inhalation powder BID for at least 2 weeks just prior to Visit 1.
- •- 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 41
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 290
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- 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
研究者
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