NL-OMON32040撤回4 期
The protective effect of levocetirizine on exercise induced airway obstruction in cold air. - icetrackstudy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 17（—）
入选标准
- •- Clinical history of allergic rhinitis and/or allergic asthma.
- •- Age between 12 and 17 years.
- •- Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%.
- •- Maximal FEV1 greater than 70% of predicted value.
- •- Clinically stable period at least 3 weeks before the study period.
排除标准
- •- Use of intranasal or systemic corticosteroids in the last 4 weeks prior to the study.
- •- Use of antihistamines, cromoglycates, anticholinergics in two weeks prior to the study.
- •- Use of intranasal or systemic corticosteroids, antihistamines, cromoglycates, anticholinergics, during the study.
- •- Use of long acting bronchodilators 24 hours before testing.
- •- Use of short acting bronchodilators 8 hours before testing.
- •- Other pulmonary or cardiac disorder.
- •- Deviation of the FEV1 of more than 12 % from baseline spirometry and the FEV1 before subsequent exercise provocation challenges.
- •- Signs of gastro-esophageal reflux.
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