NCT01011452已完成4 期
Assessment of the Effect of Oral Montelukast as Additional Treatment in the Management of Patients With Acute Severe Asthma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Difference in peak flow between active and placebo limbs by the morning after randomization
研究概览
简要总结
Patients presenting to hospital with an acute asthma exacerbation severe enough to require admission would receive full standard treatment according to British Thoracic Society guidelines in addition they would be offered the opportunity to take part in the study which would requite them to take a capsule of either montelukast or placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Asthma exacerbation requiring hospitalisation
排除标准
- •Smoking history greater than or equal to 10 pack years
- •Presenting PEFR greater than or equal to 75% predicted / best
- •Failure to demonstrate greater than or equal to 15% variability in PEFR or FEV during the study
- •Any significant and active pulmonary pathology other than asthma
- •Pregnancy or breastfeeding
- •Intended pregnancy or inability to take adequate precautions against conception
- •Patient already on Montelukast
- •Patient already on Phenobarbitone
- •Patient already on Rifampicin
- •Patient already on Phenytoin
- •Chronic airflow limitation
研究组 & 干预措施
Montelukast
Active Comparator
1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
干预措施: Montelukast (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in peak flow between active and placebo limbs by the morning after randomization
时间窗: 24 hours maximum
次要结局
- Time (hours) to achieve PEF and FEV greater than or equal to 75% best achieved in the last 12 months with greater than or equal to 25% diurnal variation(24 hours maximum)
- Time to discharge from hospital
- PEF, FEV and FVC (as % best/predicted) the morning following admission and at 4 week clinic follow up
- Proportion of days (post discharge until follow up) with a PEFR of less than or equal to 75%, and less than or equal to 50% best predicted
- Proportion of days (post discharge until follow up) with a PEFR variability of greater than or equal to 25%
- Residual volume as % predicted and RV/TLC% and FEF50 and FEF75 at 4 week out patient visit
- requirement for further medical intervention / increases in treatment following discharge
- Evaluation of quality of life over the four week out patient follow up period and expressed preference to continue on study medication
- Evaluation of economic costs and savings from the additional treatment
研究者
研究点 (1)
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