A Proof of Concept Study in Allergic Rhinitis, to Evaluate the Differential Effects Between Single and Chronic Dosing of Doxazosin on Nasal Airway Calibre
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in peak nasal inspiratory from baseline as compared with acute and chronic dosing of doxazosin versus placebo
研究概览
简要总结
Allergic rhinitis (allergic inflammation of the nose) is a common medical condition which is known to seriously decrease quality of life, aggravate preexisting conditions particularly asthma, carry significant medical treatment costs and be responsible for reduced work productivity and lost school days. A significant symptom of the condition, nasal blockage, remains difficult to treat even when using nasal corticosteroids. Decongestant medications act on the blood vessels in the nose and have an immediate effect in clearing a blocked nose but if used for more than seven days a more severe rebound congestion of the nose develops.
In this study, the investigators aim to assess the effects of doxazosin, a drug which is currently used to treat high blood pressure and symptoms of prostate enlargement, to find out if it has an effect on nasal blockage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18-70 years
- •Able to provide informed consent
- •Able to comply with the requirements of the protocol
- •Diagnosis of allergic rhinitis
- •Peak nasal inspiratory flow which is reversible to >20 l/min with oxymetazoline
- •Positive skin prick test to at least one common aeroallergen
- •Ability to withhold antihistamines, intranasal corticosteroids 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
排除标准
- •Pregnancy, planned pregnancy or lactation
- •Respiratory tract infection in the previous 2 months
- •Nasal polyps of more than Grade I on nasal endoscopy
- •Any known adverse reaction to the Investigational Medicinal Product or other quinazolines
- •Systolic BP <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 clinical trial of investigational medicinal product 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.
研究组 & 干预措施
Placebo
Participants will take 1 capsule placebo each evening
干预措施: Placebo (Other)
Doxazosin XL
Participants will take 1 capsule Doxazosin 4mg XL each evening
干预措施: Doxazosin XL (Drug)
结局指标
主要结局
Change in peak nasal inspiratory from baseline as compared with acute and chronic dosing of doxazosin versus placebo
时间窗: 12 hours; 3 to 5 weeks
次要结局
- Domiciliary peak nasal inspiratory measurements after chronic dosing(12 hours; 3 to 5 weeks)
- Nasal airways resistance after single and chronic dosing(12 hours; 3 to 5 weeks)
- Nasal histamine challenge response as measured by peak nasal inspiratory flow after chronic dosing(12 hours; 3 to 5 weeks)
- Symptoms after chronic dosing(12 hours; 3 to 5 weeks)
- Mini Rhinoconjunctivitis Quality of Life Questionnaire after chronic dosing(24 hours; 3 to 5 weeks)
研究者
Brian J Lipworth
Professor of Allergy and Pulmonology
University of Dundee