Is Levocetirizine Less Sedating Than Cetirizine? A Randomized, Double-blind, Placebo Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Modified Epworth Sleepiness Scale
研究概览
简要总结
The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine (xyzal), and placebo differ in the degree of sedation they produce and their relief of allergy symptoms.
详细描述
Levocetirizine, the R-enantiomer of cetirizine, has been found to be less sedating relative to placebo than was cetirizine in separate trials. We plan to examine whether patients who did not tolerate cetirizine due to sedation are able to tolerate levocetirizine. This study will utilize a randomized, double-blind, placebo controlled trial comparing levocetirizine, cetirizine, and placebo in regards to sedation and allergy symptom scores. Each patient will receive levocetirizine, cetirizine, and placebo in randomized order and thus serve as their own control.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 18 years of age or older
- •patients with perennial allergic rhinitis sensitized (positive RAST within the last 3 years or wheal greater than or equal to 3 mm within the last 3 years) to either:
- •dust mite
- •cat (if they own an indoor cat)
- •dog (if they own an indoor dog)
- •will allow for sensitization to tree, grass, or weed pollen, cockroach, or mold
- •history of reported sedation/somnolence when taking cetirizine
- •patient must have taken cetirizine for at least 1 week prior to discontinuing it
- •patients must have either tolerated levocetirizine in the past or have never tried levocetirizine.
排除标准
- •chronic urticaria requiring ongoing antihistamine or steroid treatment
- •atopic dermatitis requiring ongoing antihistamine or steroid treatment
- •URI or sinus infection during the 2 weeks preceding the beginning of the study
- •vasomotor (non-allergic) or irritant rhinitis
- •afrin use
- •elderly or over 77 years of age (could affect creatinine clearance) or chronic renal insufficiency
- •patients who have not tolerated levocetirizine in the past due to sedation.
- •taking other prescription or over the counter antihistamines and unwilling to stop them during the study
- •the presence of a sleep disorder such as sleep apnea or narcolepsy
- •the use of as needed sleeping aid medication
- •the presence of other chronic medical conditions which in the opinion of the investigator would prevent the subject from being able to participate effectively
研究组 & 干预措施
Levocetirzine
5 mg daily x 7 days (note = cross over = all participants receive active comparators and placebo)
干预措施: Levocetirizine (Drug)
cetirizine
10 mg daily x 7 days. Note = crossover study, so all participants recieve all active comparators and placebo.
干预措施: Cetirizine (Drug)
placebo
one tablet daily x 7 days; note that this is a crossover study so all participants receive all active comparators and placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Modified Epworth Sleepiness Scale
时间窗: 36 days of the study
Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36. This was mean data for all interventions.
Likert Score Rating Global Sedation
时间窗: duration of study (36 days)
Likert score range 1 to 9 (no sedation to extreme sedation). Highers scores indicate increased sedation. This was measured on days days 5, 12, 17, 24, 29, and 36 of the study. This was mean data for all interventions.
次要结局
- Total Four Symptom Scores (Allergy Symptoms)(same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36))
研究者
Douglas Tzanetos
Fellow
Vanderbilt University