A Double-blind, Randomized, Placebo-controlled, Cross-over, Allergen Challenge Study to Evaluate the Efficacy, Safety and Tolerability of BLX-028914 in Subjects With Allergic Rhinitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Post allergen challenge; Total Nasal Symptom Score(TNSS)
研究概览
简要总结
This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge model. BLX-028914, a selective phosphodiesterase-4 (PDE4) inhibitor with a promising safety profile,is currently under development for treatment of airway diseases by Orexo AB, Sweden.
The aim of this study is to compare the effect, safety and tolerability of 14 days treatment with BLX-0289014 in patients with SAR in an allergen challenge model versus placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 50 years of age (inclusive), male or female
- •Body Mass Index (BMI) between 18 and 28 kg/m2 (inclusive)
- •History of pollen-induced seasonal allergic rhinitis but otherwise healthy
- •Positive skin prick test for timothy and/or birch allergen
- •Sufficient reaction to nasally administered allergen at screening
- •Signed informed consent obtained
排除标准
- •Expected symptoms of seasonal allergic rhinitis during the study period
- •Nasal anatomical deviations, ongoing nasal symptoms, ongoing upper respiratory tract infection
- •Anti-allergy immunotherapy in the previous two years
- •Extensive use of nasal sprays
- •Any medication except for contraceptives, during their last five half- lives prior to the first treatment period except for occasional OTC analgesics
- •Ingestion of grapefruit or grapefruit juice or herbal remedies (e.g. St John's-wort) that may effect the enzyme CYP3A4
- •Smoking within 3 months of first treatment period
- •Clinically significant laboratory findings
- •Pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control
- •Known hypersensitivity to any constituent of the study medication or placebo
- •Participation in any other investigational study in the last three months
- •Subject anticipated not being able to adhere to study plan according to investigator judgement
研究组 & 干预措施
C
Placebo
干预措施: placebo (Drug)
B
BLX-028914 15 mg
干预措施: BLX-028914 (Drug)
A
BLX-028914 50 mg
干预措施: BLX-028914 (Drug)
结局指标
主要结局
Post allergen challenge; Total Nasal Symptom Score(TNSS)
时间窗: 10 minutes after allergen challenge
次要结局
未报告次要终点