A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Salmeterol Xinafoate/ Fluticasone Propionate Combination
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 3
- 主要终点
- 1.Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.
研究概览
简要总结
This is a 12 week, randomized, double blind, placebo-controlled, parallel group multi center study to evaluate the efficacy and safety of oral PH-797804 (6 mg) in adult patients with moderate-to-severe COPD as defined by GOLD (Global strategy for the diagnosis, management, and prevention of COPD, Update 2009, [stages II-III already treated with a background of LABA/ICS combination in 328 patients that will be conducted in 16 countries including India. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Study design: The study comprises 8 clinic visits: a Screening visit, 1 visit during the run-in phase (Week -1), a baseline/randomization visit (Week 0) at the start of the double-blind treatment phase, 4 visits during the double-blind treatment phase (Weeks 2, 6, 10 and 12) and a Follow-up visit (Week 14). At the beginning of the double-blind treatment phase (Week 0), subjects will be randomized to receive either PH-797804 (6 mg) once daily (QD) + salmeterol xinafoate/fluticasone propionate combination twice daily (BID) or matching placebo + salmeterol xinafoate/fluticasone propionate combination twice daily (BID).
Trial has been completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects between, and including, the ages of 40 and 80 years.
- •2.Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease.
- •3.Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up greater than 6 months ago.
- •4.Subjects must be treated with a LABA/ICS combination for at least 1 month prior to screening.
排除标准
- •1.A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
- •2.History or presence of significant cardiovascular disease.
- •3.ECG abnormalities.
- •4.Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study.
- •5.Evidence of organ or blood disorders.
结局指标
主要结局
1.Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.
时间窗: 12 weeks
次要结局
- 5.Global impression of change (patient and clinician).(12 weeks)
- 6.Blood sample for pharmacokinetics.(12 weeks)
- 3.Rescue bronchodilator usage(12 Weeks)
- 1.Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment.(12 weeks)
- 2.Dyspnea index scores(12 weeks)
- 4.Symptom scores.(12 weeks)
- 7.Blood and urine sample for biomarkers and molecular profiling.(12 weeks)