EUCTR2012-005035-85-GB进行中（未招募）不适用
A proof of concept study in allergic rhinitis, to evaluate the differential effects of doxazosin between single and chronic dosing on nasal airway calibre - MAN01 Alpha Blockers in Allergic Rhinitis Version 2.0
Tayside Medical Sciences Centre on behalf of University of Dundee & NHS Tayside0 个研究点目标入组 16 人开始时间: 2013年5月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
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
- 性别
- All
入选标准
- •Able to provide informed consent Able to comply with the requirements of the protocol Diagnosis of allergic rhinitis Ability to tolerate Doxazosin XL 4mg without clinically significant drop in blood pressure Peak nasal inspiratory flow which is reversible to more than 20 l/min with oxymetazoline Positive skin prick test to at least 1 common aeroallergen Ability to withhold antihistamines for duration of the study Agreement for their GP to be made aware of study participation and to receive feedback as relevant to the participant’s well being
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Pregnancy, planned pregnancy or lactation Respiratory tract infection in the previous 2 months Nasal polyps of more than Grade 1 on nasal endoscopy Any known adverse reaction to the Investigational Medicinal Product or other quinazolines Known hepatic dysfunction (as no safety data available for this) Systolic blood pressure <100mmHg Any degree of heart block Any clinically significant medical condition that may endanger the health or safety of the participant or jeopardise the protocol Participation within another trial within the last 30 days Under the age of 18 Benign hyperplasia, chronic urinary tract infections, bladder stones, overflow bladder, anuria or progressive renal failure History of oesophageal or gastrointestinal obstruction or decreased lumen diameter of the gastrointestinal tract. Concomitant use of PDE5 inhibitors (sildenafil etc.) Alpha antagonists - this is the medication under investigation Other cardiovascular medications including but not limited to: ACE inhibitors, Angiotensin II antagonists, Beta blockers, calcium channel blockers, diuretics, nitrates, phosphodiesterase type-5 inhibitors or other vasodilating medications – these in combination with doxazosin carry an increased risk of symptomatic hypotension Monoamine oxidase inhibitors (MAOIs) – antidepressant medication that can lead to significant hypotension in combination with alpha antagonists Anxiolytics and hypnotics - enhanced hypotensive and sedative effects when alpha-blockers given in combination with these. Methyldopa and levodopa – potential enhanced hypotensive effect with alpha antagonists Nasal corticosteroid spray – would confound study outcomes Oxymetazoline - this is used as an outcome of response in the study Antihistamines - the participants will be undergoing a histamine nasal challenge Sympathomimetics i.e. dopamine, ephedrine, epinephrine, metaraminol, methoxamine, phenylephrine- may reduce the effect of Doxazosin Any other medication, which in the opinion of the Investigator may put the participant at risk
研究者
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