NCT00368576已完成1 期
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Repeat Dose Study to Assess the Effect of SB-480848 on Overall Asthma Control in Adult Subjects With Persistent Asthma Controlled on Stable, Low-dose, Inhaled Corticosteroids
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 8
- 主要终点
- FEV1
研究概览
简要总结
The purpose of this study is to compare the effects of SB-480848 with placebo in subjects with asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
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
- •Male and female subjects who have documented persistent asthma for at least 3 months
- •Subjects must have been on a stable, low-dose ICS for a minimum of 4 weeks prior to the screening visit.
- •Aged 18-65 years, at screening
- •FEV1 greater than or equal to 70% predicted (ECCS, 1993)
- •Subjects must show an increase in FEV1 greater than or equal to 12% (and an absolute change >200mL) within 30 minutes following inhalation of 4 puffs of albuterol/salbutamol or 1 nebulized treatment of 2.5mg or have historical, documented evidence of reversibility, within 12 months prior to screening
- •Subjects must be willing to replace their inhaled, short-acting β2-agonist with study provided albuterol/salbutamol
- •Patient must be capable of giving informed consent and comply with the study requirements and timetable.
- •Inclusion Criteria following run in period (Prior to randomisation) Subjects will be screened based on the inclusion and exclusion criteria noted above.
- •During the run-in period [Day -14 to Day 1], subjects will be asked to maintain a diary card and document the number of puffs of rescue inhaled, short-acting β2-agonists taken, asthma-related symptoms and night time awakenings as well as morning and evening PEF measurements.
- •On the morning of Day 0, subjects will be eligible for randomisation into the study if all of the following criteria are met:
- •Subjects required, on average less than or 2 puffs per day of study provided albuterol/ salbutamol during the last 7-day period prior to Day 0 [from Day -7 to Day 1]
- •Subjects had asthma symptoms on less than or 5 out of the last 7 consecutive days of the run-in period
- •FEV1 greater than or equal to 70% predicted (ECCS, 1993).
- •FEV1 must be within ± 15% of the FEV1 value at beginning of screening.
- •Compliance with completion of the diary card.
- •Exclusion criteria:
- •The patient has life threatening asthma. A research patient must not have been hospitalized two or more times in the last year prior to Day 0 due to asthma and must not have been hospitalized within 6 months prior to Day 0
- •Subjects with daily asthma-related symptoms.
- •Subjects taking any of the medications listed in the protocol for the listed interval prior to the screening visit or during the study:
- •Subjects with historical or current evidence of any other disease.
- •Subjects with clinically significant abnormal findings on physical exam or other screening procedures.
- •Subjects who have received an investigational product within 30 days or 5 half-lives [whichever is longer] prior to the first dose of study medication
- •Subjects who have tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV.
- •Subjects with history of drug or alcohol abuse
- •Positive drug (not related to known medications the subject is taking at time of screening), alcohol or cotinine/carbon monoxide (CO) test at screening or at Day 0
- •Subjects with a history of regularly drinking more than 2 (females)/3 (males) units of alcohol a day.
- •Pregnant or nursing female subjects.
- •Female subjects of childbearing potential with an unwillingness to agree to one of the methods of contraception listed in the protocol.
- •Subjects who suffer from any medical condition which in the opinion of the investigator would compromise patient safety or ability to comply with study procedures
- •Subjects who are current smokers or have given up smoking within the previous six months or who have a smoking history > 10 pack years.
- •Subjects with history of an upper or lower respiratory tract infection or symptoms (including the common cold) within 2 weeks prior to first dose of study medication
- •Subjects who have donated more than 500ml of blood within 56 days prior to the first dose of study medication
- •Subjects who are currently receiving potent 3A4 inhibitors be excluded.
- •Subjects on β-adrenergic receptor blockers within 3 months prior to screening visit
- •Subjects previously hospitalized as a result of a methacholine challenge
排除标准
- 未提供
结局指标
主要结局
FEV1
时间窗: 6 hours post-dose, Days 7, 14 and 21
次要结局
- Methacholine challenge Amounts of certain chemicals/proteins in blood Amount of drug in the blood(before dosing and after 21 days of dosing)
- Measurements of FEV1 following single doses of SB-480848 and placebo.
- Measurements of PC20 on Day 21 +24hrs after dosing with SB-480848 and placebo.(Day 21 +24hrs after dosing)
- Blood drug levels of SB-553253 [metabolite of SB-480848] may be assessed, as appropriate.
- Urinary leukotriene concentrations after 21 days of dosing with SB-480848 and Placebo.(after 21 days)
- Blood levels of LpPLA2 and CD62 concentrations over 21-day dosing period with SB-480848 and placebo(over 21-day dosing period)
- Measurements of FEF25-75 and peak expiratory flow following single and repeat oral doses of SB-480848.
- Assessment of vitals, ECGs, safety labs and number of puffs of rescue inhaled, short-acting β2-agonists taken, asthma-related symptoms and night time awakenings, number of subjects withdrawn due to worsening of asthma on SB- 480848 and placebo.
研究者
研究点 (8)
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