EUCTR2007-004642-32-GB进行中（未招募）1 期
THE EFFECT OF THEOPHYLLINE IN PATIENTS WITH RHINITIS - Theophylline in rhinitis
niversity of East Anglia0 个研究点目标入组 27 人开始时间: 2007年11月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 27
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Males or females, aged between 16 and 65 years.
- •Weight between 50 and 150 Kg.
- •Smokers, non-smokers or ex-smokers
- •Chronic rhinosinusitis as defined as 2 or more symptoms of nasal blockage/congestion, discharge, facial pain or reduction in smell for more than 12 weeks.
- •A positive skin prick test or RAST to a perennial allergen
- •Patients with a seasonal component to their symptoms can be enrolled out with the relevant pollen season.
- •Patients must be receiving intranasal corticosteroids
- •Patients will be permitted to receive inhaled short and long acting beta2 agonists or anti-cholinergic drugs, inhaled corticosteroids (up to a dose of 2mg per day BPD equivalent), oral montelukast or oral antihistamines.
- •Able to provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Significant medical, surgical or psychiatric disease that would affect the results of the study in the opinion of the investigator.
- •Women who are pregnant or breast feeding
- •Patients with previous cardiac problems or significant renal or hepatic impairment
- •Upper respiratory tract infection in the last month as defined by yellow or green nasal discharge and increase in the usual nasal symptoms.
- •Patients consuming more than the recommended amount of alcohol (14 units per week for women and 21 units per week for men)
- •Inhaled corticosteroids at a dose greater than 2mg beclomethasone dipropionate (BDP) equivalent or oral corticosteroids or oral zafirlukast
- •Currently receiving oral theophyllines.
- •Previous adverse effects to oral or intravenous theophylline.
- •Currently any medication known to interact with theophylline including
- •oAllopurinol
- •oMacrolide, quinolone or isoniazid
- •oFluvoxamine
- •oCarbamazepine, phenytoin
- •oFluconazole or itraconazole
- •oBarbiturates
- •oOestrogens
- •oCimetidine
研究者
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