A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 250mcg Twice Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma Symptomatic on Low-Dose ICS Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 622
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8
研究概览
简要总结
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.
详细描述
A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Low-Dose ICS Therapy
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
干预措施: placebo (Drug)
Arm 2
干预措施: GW685698X (Drug)
结局指标
主要结局
Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8
时间窗: Baseline and Week 8
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.
次要结局
- Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period(From Baseline up to Week 8)
- Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period(From Baseline up to Week 8)
- Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis(From Baseline up to Week 8/Early Withdrawal)
- Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8(Baseline and Week 8)
- Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period(From Baseline up to Week 8)
- Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period(From Baseline up to Week 8)
- Hematocrit at Baseline and Week 8(Baseline and Week 8)
- Hemoglobin at Baseline and Week 8(Baseline and Week 8)
- Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8(Baseline and Week 8)
- Red Blood Cells (RBC) Count at Baseline and Week 8(Baseline and Week 8)
- Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8(Baseline and Week 8)
- Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8(Baseline and Week 8)
- Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8(Baseline and Week 8)
- Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8(Baseline and Week 8)
- Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal(Baseline and Week 8/Early Withdrawal)
- Urine Specific Gravity at Baseline and Week 8/Early Withdrawal(Urine specific gravity at Baseline and Week 8/Early Withdrawal)
- Urine pH at Baseline and Week 8/Early Withdrawal(Baseline and Week 8/Early Withdrawal)
- 24-hour Urinary Cortisol Excretion at Baseline and Week 8(Baseline and Week 8)
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8(Baseline and Week 8)
- Change From Baseline in Heart Rate at Week 8(Baseline and Week 8)
- Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period(From the first dose of study medication up to Week 8/Early Withdrawal)
- Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period(From the first dose of study medication up to Week 8/Early Withdrawal)