NCT00334698已完成不适用
A Randomized, Double Blind, Placebo-controlled, Four Way Cross-over Study to Assess the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Cetirizine Alone on Symptoms Scores and Rhinomanometry in Patients With Allergic Rhinitis Following Pollen Exposure in the Fraunhofer Environmental Challenge Chamber (ECC)
Fraunhofer-Institute of Toxicology and Experimental Medicine2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2006年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change of nasal obstruction symptom score
研究概览
简要总结
The aim of this study is to assess the efficacy on nasal congestion and other allergic symptoms and the onset of action of an oral combination of cetirizine and pseudoephedrine in comparison to the single substances under controlled pollen exposure in an Environmental Challenge Chamber (ECC).
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, aged 18-55 years.
- •Women will be considered for inclusion if they are:
- •Not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing.
- •Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
- •Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomized partner, abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication and to continue until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, some IUDs)
- •FEV1 > 80% of predicted at screening.
- •Absence of any structural nasal abnormalities or nasal polyps on examination, absence of a history of frequent nose bleeding or recent nasal surgery.
- •Absence of conditions or factors, which would make the subject unlikely to be able to stay in the Fraunhofer ECC for 6 hours.
- •Non smokers or smokers with a history of less than 10 pack years.
- •Able and willing to give written informed consent to take part in the study.
- •Available to complete all study measurements.
- •History of allergic rhinitis to grass pollen and a positive skin prick test for Dactylis glomerata pollen at or within 12 months prior to the screening visit.
- •Subject must exhibit a moderate response upon 4000 Dactylis glomerata pollen grains/m3 during 2 hours in the ECC on visit
- •Subjects with mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function may be included.
排除标准
- •History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening and during the study.
- •Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures.
- •Administration of oral, injectable or dermal corticosteroids within 8 weeks or intranasal and/or inhaled corticosteroids within 4 weeks of the screening visit.
- •Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDS), anti-depressant drugs, anti-histamines and anti-asthma, anti-rhinitis or hay fever medication (other than short acting inhaled beta-agonists) for 1 week prior to screening and throughout the course of the study.
- •Paracetamol up to 1g per day is permitted for the treatment of minor ailments, e.g. headache.
- •Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
- •Known hypersensitivity, allergic reactions or intolerance to cetirizine, pseudoephedrine or any of the other ingredients.
- •Subject receiving monoamine oxidase inhibitors or has received these agents in the last two weeks before dosing.
- •Subject is undergoing allergen desensitisation therapy.
- •There is a risk of non-compliance with study procedures.
- •Participation in another clinical trial 30 days prior to enrolment.
结局指标
主要结局
Change of nasal obstruction symptom score
次要结局
未报告次要终点
研究者
研究点 (2)
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