EUCTR2004-002872-41-GB进行中（未招募）1 期
A Study to Validate Key Therapeutic Targets and Biomarkers during Allergen Exposure in Subjects with Allergic Rhinitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Males or females aged between 18 and 65 years inclusive
- •Female subjects of childbearing potential must be using effective forms of contraception (i.e. abstinence, oral contraceptives, Norplant*, documented placement of intrauterine device (IUD) with failure rate of less than 1%, a diaphragm with spermicide, a condom and diaphragm with spermicide or Depo-Provera*) for at least one month prior to screening and throughout the study period.
- •Subjects with a known history of SAR with a clinically significant positive skin prick test/RAST to any of 6 common allergens
- •No signs or symptoms of rhinitis outside of the relevant airborne allergen season(s)
- •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
- •As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study
- •Subject is female who is pregnant or lactating
- •History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments
- •History of abnormal bruising or bleeding
- •Symptoms of rhinitis at inclusion indicated by total VAS score of >40 for the combined symptoms scores for blockage, rhinorrhoea, sneezing, itching) or a single symptom with a VAS score >20
- •Subjects not showing a nasal response to allergen concentration =< 10,000 BU/ml
- •Subjects with positive skin prick test for Dust House Mite
- •Subjects showing demonstrating hypersensitivity to the vehicle challenge at screening
- •Concurrent purulent nasal infection
- •Requirement for > 250µg inhaled FP > 500µg inhaled budesonide propionate (BDP; or equivalent) per day as treatment for asthma
- •Inability to abstain from all intranasal or oral medication to treat nasal allergy from study visit 1 to the completion of the study including: sodium cromoglycate, anti-histamines, alpha-adrenergic agonists and corticosteroids
- •Use of any medications that significantly inhibit the Cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
- •Current smokers or anyone that has regularly smoked over the last 6 months
- •Female subjects who are unwilling or unable to use an appropriate method of contraception
研究者
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