A Randomized, Open Labeled Comparative Study to Assess the Efficacy and Safety of Controller Medications as Add on to Inhaled Steroid and Long Acting β2 Agonist in Treatment of Moderate to Severe Persistent Bronchial Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome was percentage of improvement in FEV1
研究概览
简要总结
The purpose of this study is to know the effect of another controller medication add on to the inhaled corticosteroid and long acting β2 agonist on clinical symptom, lung function and compliance in patients of moderate to severe persistent bronchial asthma.
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
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 15 to 65 years of either sex
- •had clinically diagnosed Bronchial asthma
- •had poor asthma control defined by ACQ score (asthma control questionnaire) of 1.5 or greater
- •FEV1 (Forced Expiratory Volume at 1 second) value of 50% or more of predicted
- •improvement in FEV1 was greater than 15% after bronchodilator inhalation
排除标准
- •major illness of system other than respiratory major respiratory illness other than asthma taken long acting anti histaminic within a preceding week of enrollment Smokers Pregnant and lactating woman history of hypersensitivity to any of above drugs
研究组 & 干预措施
inhaled budesonide and formeterol plus oral montelukast
1st two weeks -run in period .All three participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet montelukast (10 mg/day)orally in the evening
干预措施: inhaled budesonide and formeterol plus oral montelukast (Drug)
inhaled budesonide and formeterol plus oral doxophylline
1st two weeks -run in period, all three participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks
干预措施: inhaled budesonide and formeterol plus oral doxophylline (Drug)
Doubling the dose of inhaled budesonide and formeterol
1st two weeks -run in period all the participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg /puff + formeterol 6 mcg/puff) two times a day plus metered dose inhaler of budesonide (200 mcg/puff) two times a day
干预措施: Doubling the dose of inhaled budesonide and formeterol (Drug)
结局指标
主要结局
The primary outcome was percentage of improvement in FEV1
时间窗: 10 weeks
次要结局
- Improvement in PEFR (Peak expiratory flow rate), ACQ scores(asthma control questionnaire score), rates of adverse drug reaction and EPACs (episodes of poor asthma control)(10 weeks)