A Randomised, Double-blind, Double Dummy, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening All Administered by Inhalation Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 669
- 试验地点
- 1
- 主要终点
- Peak expiratory flow (PEF)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once daily either in the morning or the evening and GW685698X 250mcg administered once daily in the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients aged between 16- 65 years.
- •Male and female; female subjects must be non-child bearing potential or of childbearing potenetial with negative pregnancy test and willing to use acceptable contraceptive methods
- •Documented clinical history of persistent asthma first diagnosed at least 6 months prior to Visit 1
- •Currently receiving inhaled short-acting beta-2 agonists for symptom relief
- •A lung function of between 50 to 90% predicted (PEF)
- •Increase in PEF of at least15%, 20 minutes after inhalation of 400mcg salbutamol
排除标准
- •History of respiratory tract infection and/or exacerbation of asthma within a period of 4 weeks prior to Visit 1
- •History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures.
- •A history of two or more asthma exacerbations requiring treatment with oral corticosteroids or hospitalisation in the 6 months before Visit
- •Past or present disease that, as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematologic disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis and bronchopulmonary dysplasia).
- •Known or suspected sensitivity to corticosteroids, VENTOLIN, or the constituents of ROTADISKS (e.g., lactose).
- •Undergoing allergen desensitisation therapy.
- •Neurological or psychiatric disease or history of drug or alcohol abuse that would interfere with the subject's proper completion of the protocol requirements.
- •Is a current smoker or has a smoking history of 10 pack years or more (e.g., 20 cigarettes/day for 10 years). Note: Current smoker is defined as currently smoking or stopped smoking within 6 months of screening visit.
研究组 & 干预措施
GW685698X (fluticasone furoate) 100mcg Morning
干预措施: GW685698X (fluticasone furoate) 100mcg Morning (Drug)
GW685698X (fluticasone furoate) 100mcg Evening
干预措施: GW685698X (fluticasone furoate) 100mcg Evening (Drug)
GW685698X (fluticasone furoate) 250mcg Evening
干预措施: GW685698X (fluticasone furoate) 250mcg Evening (Drug)
Placebo
干预措施: GW685698X (fluticasone furoate) 100mcg Morning (Drug)
Placebo
干预措施: GW685698X (fluticasone furoate) 100mcg Evening (Drug)
Placebo
干预措施: GW685698X (fluticasone furoate) 250mcg Evening (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Peak expiratory flow (PEF)
时间窗: 28 days
Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning compared with GW685698X 100mcg once daily in the evening by inhalation via DISKHALER.
次要结局
- Peak expiratory flow (PEF)(28 days)
- PEF(28 days)
- Clinic lung function(28 days)