EUCTR2006-005819-10-DE
进行中（未招募）
不适用
Influence of tiotropium bromide (Spiriva ®) plus salbutamol versus salbutamol on the mucin secretion and sputum properties in subjects with a COPD exacerbation-TIBROMUC- - TIBROMUC
Philipps-University Marburg0 个研究点2007年10月26日
适应症Anticholinergic bronchodilators, such as ipratropium bromide, may be used in combination with beta adrenergic agonists as SAlbutamol to produce bronchodilation in excess of that achieved by either agent alone.Therefore we will treat both study arms with salbutamol. One group A will receive tiotropium bromide with salbutamol, while the other group B will receive salbutamol.MedDRA version: 8.1Level: LLTClassification code 10010952Term: COPD
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Anticholinergic bronchodilators, such as ipratropium bromide, may be used in combination with beta adrenergic agonists as SAlbutamol to produce bronchodilation in excess of that achieved by either agent alone.Therefore we will treat both study arms with salbutamol. One group A will receive tiotropium bromide with salbutamol, while the other group B will receive salbutamol.
- 发起方
- Philipps-University Marburg
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •provided written informed consent
- •Hospitalized male or female subjects’ \= 35 years of age.
- •Subject who has COPD 2 or 3 according to the GOLD criteria (see Table 1\)
- •FEV1/FVC \< 70%
- •30% \<\= FEV1 (GOLD 3\) \< 50% \<\= FEV1 (GOLD 2\) \< 80% predicted
- •with chronic symptoms (cough, sputum production)
- •Subjects must have a clinical diagnosis of an acute exacerbation of an underlying COPD (GOLD 2 and 3\) supported by at least two of the following signs and symptoms: increased sputum purulence, increased dyspnea, or increased sputum volume (Anthonisen Criteria I or II).
- •The onset of signs and symptoms of the current exacerbation must occur within 7 days before start of evaluation.
- •Subjects may have taken inhaled anticholinergic\- or ß2\-agonists drugs prior to the study, except tiotropium bromide.
- •Subjects may have taken inhaled corticosteroids (ICS) prior to the study.
排除标准
- ••Subjects who have taken tiotropium bromide in the last 4 weeks.
- •Subjects should not have received any mucolytic drug such as acetylcysteine or ambroxol during the study and 24 hours prior to the study.
- •Subjects who inhale corticosteroids during the time of study;
- •whereas on the day and the day after evaluation inhaled corticosteroids are accepted.
- •Subject who has suspected or known (positive chest radiograph) pneumonia.
- •Subject who has suspected or known asthma bronchiale.
- •Subject who requires parenteral antibiotic therapy.
- •Subject who has taken:
- •oA systemic antibiotic within 2 weeks before study drug administration
- •oAny long acting antibiotic (e.g., penicillin G benzathine or azithromycin) within 4 weeks before study drug administration.
结局指标
主要结局
未指定
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