NCT02182700终止3 期
Open Study on the Efficacy and Safety of Combivent® Aerosol (120 mcg Salbutamol Sulfate Plus 20 mcg Ipratropium Bromide) + Spacer, 12 to 24 Puffs, in Adult Patients With Moderate to Severe Asthma Crisis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 47
- 主要终点
- Number of patients discharged with a peak flow expiratory flow rate (PEFR) >= 70% predicted normal value at the end of the first and the second treatment
研究概览
简要总结
Study to evaluate the bronchodilator efficacy and safety of a fixed combination of salbutamol sulfate (120 mcg) + ipratropium bromide (20mcg) (Combivent® MDI) in aerosol plus spacer in adult patients with moderate-to-severe asthma crisis who arrived at the emergency room.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with a diagnosis of asthma according to the American Thoracic Society (ATS) presenting at the emergency room with an acute moderate and/or severe asthma attack
- •Patients aged between18 to 40 years
- •Patients able to perform spirometry (PEFR and FEV1)
- •PEFR < 60% and > 25 % of predicted normal value or a FEV1 <= 60% of predicted normal value
- •Patients able to sign witnessed informed consent
排除标准
- •Patients with very severe or life threatening obstruction, manifested by:
- •Cyanosis of tongue and lips
- •Confusion, drowsiness, coma or exhaustion
- •Silent chest on auscultation or weak respiratory effort
- •PEFR < 25% the predicted normal value
- •Bradycardia (of less 60 beats/min)
- •Patients with a smoking history of more than 10 pack/years
- •Patients with chronic obstructive pulmonary disease (COPD)
- •Patients on treatment for or suspected as having glaucoma
- •Patients with uncontrolled hypertension
- •Patients with known allergy or contra-indications to either salbutamol, ipratropium or hydrocortisone or their excipients
- •Female patients known or suspected to be pregnant or nursing
- •Patients known or suspected on clinical grounds to have pneumonia, pneumothorax or pneumomediastinum
- •Patients with a history of chest surgery
- •Patients with other respiratory conditions if diagnosed. These included pulmonary fibrosis, bronchiectasis, cystic fibrosis, pulmonary tuberculosis, pulmonary complications of AIDS, lung cancer
- •Patients requiring drugs for the treatment of the acute asthma attack other than the study drug, hydrocortisone or oxygen
- •Patients who have previously recruited into this study
- •Patients who have been on other investigational drugs within three months prior to study entry
- •Patients with acute myocardial infarction, pulmonary edema or other life threatening disease, which in the judgment of the ER (Emergency room) physician precluded entry into the study
- •Patients with obvious or previous diagnosed serious hepatic or renal impairment or bladder neck obstruction
研究组 & 干预措施
Combivent® aerosol
Experimental
干预措施: salbutamol sulfate + ipratropium bromide (Drug)
结局指标
主要结局
Number of patients discharged with a peak flow expiratory flow rate (PEFR) >= 70% predicted normal value at the end of the first and the second treatment
时间窗: 60 and 120 min after starting treatment
次要结局
- Number of relapses and/or new episodes(7 days after finishing treatment)
- Number of patients whose PEFR >= 60% within the first or the second hour(60 and 120 min after start of treatment)
- Hospitalisation period at the Intensive Care Unit (ICU)(up to 3rd hour after treatment)
- Hospitalisation time at the general ward(up to 3rd hour after treatment)
研究者
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