Assessment of Bronchodilatory Effects of Cetirizine in Adults With Concomitant Allergic Rhinitis and Mild Asthma as Measured by Impulse Oscillometry.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in impulse oscillometry result
研究概览
简要总结
Primary Objective :
To compare the acute bronchodilatory effects of cetirizine 10 mg tablet and nebulized levalbuterol using impulse oscillometry technique in asthmatic subjects aged 18 to 65 years old who have allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.
Secondary Objective:
To assess the bronchodilatory effects of cetirizine 10 mg tablet versus placebo after two weeks of therapy using impulse oscillometry technique in subjects 18 to 65 years old who have allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.
详细描述
OBJECTIVES:
Primary Objective :
To compare the acute bronchodilatory effects of cetirizine 10 mg tablet and nebulized levalbuterol using impulse oscillometry technique in asthmatic subjects aged 18 to 65 years old who have allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.
Secondary Objective:
To assess the bronchodilatory effects of cetirizine 10 mg tablet versus placebo after two weeks of therapy using impulse oscillometry technique in subjects 18 to 65 years old who have allergic rhinitis and show clinical evidence of bronchial hyper-reactivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 65 years of age
- •Physician diagnosis of mild asthma based on the NIH guidelines
- •Physician diagnosis of allergic rhinitis and confirmed by at least 3+ skin test response to at least one allergen
- •Evidence of abnormal, reversible airway function on impulse oscillometry
- •Ability to cooperate in measurement of impulse oscillometry
排除标准
- •Treatment with inhaled or oral corticosteroids within one month of screening visit
- •Change in dosage of intranasal corticosteroids, or oral anti- leukotrienes within one month of screening visit. Subjects on constant dose of intranasal corticosteroids or anti-leukotrienes for one month or more will be allowed in the study.
- •Known history of reflux, lung disease, or congenital heart disease
- •Known history of adverse reaction to cetirizine
研究组 & 干预措施
Cetirizine
Cetirizine 10 mg orally once a day
干预措施: Cetirizine (Drug)
Sugar pill
This will be the placebo arm
干预措施: Placebo (Drug)
结局指标
主要结局
Change in impulse oscillometry result
时间窗: Baseline and after three weeks of study intervention
Impulse oscillometry measures airway resistance which is a reflection of dilation of the bronchial airways
次要结局
未报告次要终点
研究者
Sheldon Spector, MD
Principal Investigator
California Allergy and Asthma Medical Group, Inc.