A Randomised, Double-blind, Placebo-controlled, Three-way Crossover, Repeat Dose Pilot Study Comparing the Effect of Inhaled Fluticasone Furoate/GW642444M Combination and Fluticasone Furoate on the Allergen-induced Early Asthmatic Response in Subjects With Mild Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
研究概览
简要总结
We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist (LABA)/ inhaled corticosteroid (ICS) combination product on protection from allergic triggers in asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
- •Females of non-child bearing potential.
- •Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation
- •Pre-bronchodilator FEV1 >70% of predicted at screening
- •Subjects who are current non-smokers
- •Methacholine challenge PC20 < 8 mg/mL at screening
- •Screening allergen challenge demonstrates that the subject experiences an early asthmatic response
排除标准
- •Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- •Subject is hypertensive at screening
- •Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
- •History of life-threatening asthma
- •Symptomatic with hay fever at screening or predicted to have symptomatic hayfever
- •Unable to abstain from short acting beta agonists
- •Unable to abstain from antihistamines
- •Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-asthma anti-rhinitis or hay fever medication
- •The subject has participated in a study with a new molecular entity during the previous 3 months or has participated in 4 or more clinical studies in the previous 12 months
- •undergoing allergen desensitisation therapy
研究组 & 干预措施
Placebo
Placebo Inhaler
干预措施: Placebo (Drug)
inhaled corticosteroid(ICS)/long acting bronchodilator (LABA)
ICS/LABA inhaler
干预措施: FF/Vilanterol (VI; GW642444M) (Drug)
ICS
ICS inhaler
干预措施: Fluticasone Furoate (Drug)
结局指标
主要结局
Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
时间窗: Baseline and Day 29 of each treatment period (up to Study Day 197)
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29.
次要结局
- Minimum FEV1 Absolute Change From Baseline Between 0-2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period(Baseline and Day 29 of each treatment period (up to Study Day 197))
- Maximum Percent Decrease From Baseline in FEV1 Between 0 2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period(Baseline and Day 29 of each treatment period (up to Study Day 197))
- Number of Participants With Treatment-emergent Adverse Events (AEs)(From the start of study medication until Follow-up/Early Withdrawal (up to 197 days))