NCT00691951已完成3 期
Comparative Effects of Budesonide and Budesonide/Formoterol (Symbicort) on Asthma Control in Smoking Asthmatic Subjects: A Pilot Study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 4
- 主要终点
- Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ)
研究概览
简要总结
A reduced response to inhaled corticosteroids (ICS) has been reported in smoking compared to non-smoking asthmatic patients. However, the comparative response to other currently prescribed medications such as combination therapy of long-acting beta agonists and ICS remain to be further evaluated.
No significant differences were found between our group of subjects in regard to changes in asthma control pulmonary function and airway inflammation following budesonide or the association of budesonide with formoterol for a period of 2 months. This should be further explored in larger groups of subjects.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthmatic non-smokers or ex-smokers (less than 10 pack/years)
- •Asthmatic smokers (more than 5 cigarettes a day and more than 5 pack/years
- •FEV1 greater than 70%
- •No more than 3 doses of rescue medication (bronchodilator) per day
排除标准
- •Mentally or legally incapacitated thus preventing informed consent from being obtained
- •Other pulmonary disorder
- •History of upper respiratory tract infection in the last month
- •Pregnant or lactating women
结局指标
主要结局
Comparative changes before and after treatments in each group for Asthma Control Questionnaire (ACQ)
次要结局
- Other control scores (ACSS score) and rescue B2 agonist need
- Comparative changes in FEV1
- Quality of life questionnaire
- Morning and evening PEF
- Total and differential cell counts in induced sputum and ECP and MPO
研究者
研究点 (4)
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