NCT02182713已完成4 期
Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
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
- 30
- 主要终点
- Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%)
研究概览
简要总结
The purpose of this study was to evaluate whether 2 puffs of fixed combination of aerosolized 120 mcg salbutamol sulphate (equivalent to 100 mcg of the base) + 20 mcg ipratropium bromide confers significant additional protection against metacholine induced bronchoconstriction in asthmatic atopic patients when compared to 2 puffs of aerosolized 100 mcg salbutamol alone.
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
- 7 Years 至 12 Years（Child）
- 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 Criteria
- •Patients aged 7 to 12 years inclusive
- •Patients able to perform spirometry
- •Patients with FEV1 (forced expiratory volume in the first second) ≥ 80% of predicted normal value after saline
- •Patients with PD20 (provocative dose that reduces FEV1 by 20 %) metacholine lower than 8 mg/ml
- •Patients or responsible relatives willing and able to sign an informed consent form
排除标准
- •Patients on treatment for or suspected as having glaucoma
- •Patients with known allergy of contra-indications to either salbutamol, ipratropium or their excipients
- •Patients 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 include pulmonary fibrosis, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary tuberculosis, pulmonary complications of AIDS
- •Patients requiring drugs for the treatment of the acute asthma attack other than the study drugs or oxygen
- •Patients who have been previously recruited into this study
- •Patients with myocardiopathy, pulmonary edema or other life threatening diseases, which in the judgement of the pediatrician precludes their entry into the study
- •Patients with obvious or previously diagnosed serious hepatic or renal disease
- •Patients who have been under the following drugs within the specified periods of time prior to determination of Baseline FEV1 or metacholine challenge
- •Short acting β2 agonists: 6 hours
- •Long acting β2 agonists: 12 hours
- •Ipratropium bromide: 8 hours
- •DSCG (disodium cromoglicate): 7 days
- •Nedocromil: 7 days
- •Short acting β2 agonists: 18 hours
- •Anticholinergics: 7 days
- •Short acting theophylline: 24 hours
- •Long acting theophylline: 72 hours
- •Antihistamines: 7 days
- •Astemizole: 3 months
- •Ketotifen: 3 months
- •INHALED or ORAL: Other investigational drugs: 3 months
- •INHALED or ORAL: Corticosteroids: 30 days
研究组 & 干预措施
Arm 1 - CombiventTM followed by Salbutamol
Experimental
干预措施: Salbutamol sulfate/Ipratropium bromide (Drug)
Arm 1 - CombiventTM followed by Salbutamol
Experimental
干预措施: Salbutamol (Drug)
Arm 2 - Salbutamol followed by CombiventTM
Active Comparator
干预措施: Salbutamol sulfate/Ipratropium bromide (Drug)
Arm 2 - Salbutamol followed by CombiventTM
Active Comparator
干预措施: Salbutamol (Drug)
结局指标
主要结局
Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%)
时间窗: Baseline and 30 minutes after treatment
次要结局
- Change from baseline in systolic and diastolic blood pressure(Baseline, 30 and 60 min after treatment)
- Change from baseline in heart rate(Baseline, 30 and 60 min after treatment)
- Change from baseline in respiratory rate(Baseline, 30 and 60 min after treatment)
- Occurrence of adverse events(up to 8 days)
- SaO2 (oxygen saturation) during metacholine challenge(continuously after adminstration of study drug)
研究者
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