ACTRN12612000816853已完成3 期
A Randomized, double-blind, placebo-controlled trial to assess the effects of Oral Montelukast on forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR) in patients with acute asthma exacerbation
Hilton Pharma (Pvt.) Limited0 个研究点目标入组 100 人开始时间: 2012年8月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 16 Years 至 o limit(—)
- 性别
- All
入选标准
- •All adults (age 16 and above), presenting to the ER or clinic of Aga Khan University Hospital (AKUH) with acute asthma exacerbation will be eligible for the study. They will be included if they have one or more features suggestive of ‘Acute asthma exacerbation’ according to GINA Guidelines and are hospitalized
- •Acute asthma exacerbation is characterized by a progressive increase in shortness of breath, cough, wheezing or chest tightness, and by a decrease in expiratory flow that can be quantified by simple measures of pulmonary function such as PEFR and FEV1. The severity of exacerbations may range from mild to life-threatening.
- •Hospital admission criteria will be standardized:
- •a.FEV1 < 70% predicted or PEFR < 300 L/min after receiving initial treatment in the emergency room
- •b.Respiratory rate > 24 breaths/min
- •c.No improvement in symptoms like shortness of breath or wheezing
排除标准
- •1.Under 16 years of age
- •2.Pregnancy
- •3.Patients who do not consent to participate
- •4.History of tobacco use > 10 pack years
- •5.Any acute concurrent medical condition like pneumonia, congestive heart failure or pneumothorax on presentation to the ER
- •6.Concomitant therapy with systemic corticosteroids or le ukotriene modifiers at time of admission
- •7.FEV1 > 70% predicted or PEFR > 300 L/min
- •8. Acute respiratory failure requiring mechanical ventilation
- •9.Patients initially recruited in the study but improved after initial treatment and discharged from the ER
研究者
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