EUCTR2007-001587-70-DE进行中（未招募）不适用
A randomized, double-blind, placebo-controlled crossover study to assess the efficacy's reproducibility of a combination of Pseudoephedrine and Cetirizine on symptom scores and rhinomanometry in patients with allergic rhinitis following pollen exposure in the Fraunhofer Environmental Challenge Chamber (ECC) in- and outside the grass pollen season
Fraunhofer Gesellschaft0 个研究点开始时间: 2007年4月10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
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
- •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 (vasectomised 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 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.
- •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 2, which is defined as a Nasal Obstruction Symptom Score (NOSS) of at least 2 (scored on a scale from 0 to 3) and a Total Nasal Symptom Score of at least 6 (TNSS is the sum of obstruction, rhinorrhea, itch, and sneeze, each of which has been scored on a scale from 0 to 3) at least once during the screening challenge.
- •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.
- •Able and willing to give written informed consent to take part in the study.
- •Available to complete all study measurements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects showing clinical symptoms of perennial allergic rhinitis.
- •History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening.
- •Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures.
- •Administration of oral, injectable or dermal corticosteroids within 8 weeks or intranasal and/or inhaled corticosteroids 4 weeks prior to the screening visit.
- •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.
- •Specific Immunotherapy (SIT) within the last two years prior to screening.
- •There is a risk of non-compliance with study procedures.
- •Participation in another clinical trial 30 days prior to enrolment.
研究者
相似试验
已完成
不适用
A randomized, double-blind, placebo-controlled cross-over study of epicutaneous immunotherapy for food allergy.Food allergyJPRN-UMIN000033049Department of Pediatrics, Hachioji Hospital, Faculty of Medicine, Tokai University13
已完成
不适用
A randomized, double-blind, placebo-controlled crossover study to assess the effect of 12-week fibre supplementation on mixed-meal challenge response in adultsHealth status1002766510000546NL-OMON55244Centre for Human Drug Research64
尚未招募
Unknown
A clinical trial on the effect of lactulose on mineral absorption.JPRN-UMIN000052813KSO Corporation100
进行中（未招募）
1 期
A phase IIb study of OligoG in subjects with cystic fibrosisCystic FibrosisEUCTR2014-000844-13-SEAlgipharma AS76
进行中（未招募）
1 期
A phase IIb study of OligoG in subjects with cystic fibrosisCystic FibrosisEUCTR2014-000844-13-DKAlgipharma AS76