Study HZA106851: A Study of the Effects of Inhaled Fluticasone Furoate/GW642444 Versus Placebo on the HPA Axis of Adolescent and Adult Asthmatics
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42
研究概览
简要总结
The purpose of this study is to assess the effect of six weeks' treatment with two once-daily strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient with ability to comply with study requirements and complete two 24-hour clinic visits
- •Clinical diagnosis of asthma for greater than/equal to 12 weeks
- •Reversibility FEV1 of at least twelve percent and two hundred milliliters
- •FEV1 greater than or equal to fifty percent of predicted
排除标准
- •History of life threatening asthma
- •Respiratory infection or oral candidiasis
- •Asthma exacerbation
- •Uncontrolled disease or clinical abnormality
- •Allergies to study drugs, study drugs' excipients, medications related to study drugs
- •Taking another investigational medication or prohibited medication
研究组 & 干预措施
FF/444 Dose B
Fluticasone furoate/GW642444 Dose B inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study
干预措施: Fluticasone Furoate/GW642444 Inhalation Powder (Drug)
FF/444 Dose B
Fluticasone furoate/GW642444 Dose B inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study
干预措施: Placebo Oral Capsule (Drug)
FF/444 Dose A
Fluticasone furoate/GW642444 Dose A inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study
干预措施: Fluticasone Furoate/GW642444 Inhalation Powder (Drug)
FF/444 Dose A
Fluticasone furoate/GW642444 Dose A inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study
干预措施: Placebo Oral Capsule (Drug)
Placebo
Placebo inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study
干预措施: Placebo Inhalation Powder (Drug)
Placebo
Placebo inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study
干预措施: Placebo Oral Capsule (Drug)
Prednisolone
Placebo inhalation powder once daily for 6 weeks' treatment + 1 oral prednisolone 10mg capsule each day on the last 7 days of the study
干预措施: Placebo Inhalation Powder (Drug)
Prednisolone
Placebo inhalation powder once daily for 6 weeks' treatment + 1 oral prednisolone 10mg capsule each day on the last 7 days of the study
干预措施: Prednisolone Oral Capsule (Drug)
结局指标
主要结局
Ratio From Baseline of the Serum Cortisol Weighted Mean (0-24 Hours) on Day -1/1 (Baseline) and Day 42
时间窗: Day -1/1 (Baseline) and Day 42
Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day -1/1 (Baseline) and Day 42. Serum cortisol weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 9, 12, 14, 16, 20, 22, and 24 hours (relative to the "0" time point). Because values are on a logged scale, the ratio of the endpoint to Baseline is presented, as it is a measure of the difference from Baseline.
次要结局
- Ratio From Baseline of the Serum Cortisol Area Under the Concentration-time Curve (AUC) (0-24 Hour) on Day -1/1 (Baseline) and Day 42(Day -1/1 (Baseline) and Day 42)
- Ratio From Baseline of 0-24 Hour Urinary Free Cortisol Excretion on Day -1/1 (Baseline) and Day 42(Day -1/1 (Baseline) and Day 42)
- Ratio From Baseline of Serum Cortisol Trough (0-24 Hours) at Day -1/1 (Baseline) and Day 42(Day -1/1 (Baseline) and Day 42)
- Plasma FF and VI Pharmacokinetic (PK) Concentration(Day 42)
- Cmax for FF on Day 42(Day 42)
- Tmax and Tlast of VI at Day 42(Day 42)
- Change From Baseline in Hemoglobin Values at Day 42/EW(Baseline and Day 42/EW)
- Change From Baseline in Albumin and Total Protein Values at Day 42/EW(Baseline and Day 42/EW)
- Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine Values at Day 42/EW(Baseline and Day 42/EW)
- Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period(From the start of study medication until Day 42 (Visit 5)/Early Withdrawal)
- Change From Baseline in Basophil, Eosinophil, Lymphocyte, Monocyte, and Segmented Neutrophil Values at Day 42/Early Withdrawal (EW)(Baseline and Day 42/Early Withdrawal (EW))
- AUC(0-t) and AUC(0-24) for FF on Day 42(Day 42)
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Days 14, 28, 42, and Maximum Post-Baseline(Days 14, 28, 42, and EW)
- Tmax and Tlast of FF at Day 42(Day 42)
- AUC(0-t) for VI on Day 42(Day 42)
- Cmax for VI on Day 42(Day 42)
- Change From Baseline in Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 42/EW(Baseline and Day 42/EW)
- Change From Baseline in Eosinophil, Total Neutrophil, Platelet, and White Blood Cell (WBC) Count Values at Day 42/EW(Baseline and Day 42/EW)
- Change From Baseline in Hematocrit Values at Day 42/EW(Baseline and Day 42/EW)
- Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) Values at Day 42/EW(Baseline and Day 42/EW)
- Change From Baseline in Pulse Rate at Days 14, 28, 42, and Maximum Post-Baseline(Days 14, 28, 42, and EW)