The Effects of Omalizumab on the Late-phase Response to Nasal Allergen Challenge
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- The the Size of the 8 Late-phase Skin Response
研究概览
简要总结
This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, cells in the blood and cells in the skin that cause allergies. The investigators will compare the changes in the nose to changes in the skin and blood cells.
Objective: To test the hypothesis that treatment with omalizumab will decrease the nasal allergen challenge late-phase eosinophil count in nasal brushings at the time when blood basophils have become hypo-responsive to in vitro allergen exposure.
详细描述
This is a randomized, placebo-controlled, double-blind, parallel group design study that includes 3.5 months of treatment with omalizumab or placebo and a 3 month follow-up. All subjects will be cat allergic.
Twenty four subjects (1:1 randomization) will undergo a cat allergen nasal challenge prior to treatment and another challenge after 2 months of treatment or when their blood basophils become hyporesponsive to cat allergen in vitro. A second group of 10 subjects (1:1 active:placebo), will not undergo nasal challenges. This group will participate in an ancillary study in which the effects of omalizumab on gene expression profiles in peripheral blood cells will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Asthma with baseline FEV1 < 80% predicted, and/or moderate to severe asthma classification per the 2007 NAEPP guidelines.
- •Individuals with total serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment.
- •Individuals with reduced hematocrit (< 32%), WBC count (2400/microliter), platelet count (< 75000/microliter), and increased creatinine (> 141.4 micromolar/L), or AST (> 100 IU/L).
- •Individuals with body weight less than 30 kg or greater than 150 kg.
- •Pregnant females or females with plans to become pregnant or breastfeed during the duration of the study.
- •Individuals with perforated nasal septum, structural nasal defects, large nasal polyps causing obstruction, evidence of acute or chronic sinusitis.
- •History of malignancy, anaphylaxis or bleeding disorder.
- •Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- •Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- •Use of any investigational drugs within 8 weeks of participation.
- •Contraindications to omalizumab including patients with a previous hypersensitivity to omalizumab.
- •Recent recipient of any licensed or investigational live attenuated vaccine(s) within two months of study initiation such as flu mist.
- •Any prior use of omalizumab.
- •Frequent episodes of acute sinusitis (>2 documented episodes per year) or active sinusitis within 2 weeks prior to enrollment
- •Use of aeroallergen immunotherapy within 5 years prior to enrollment
- •Current or within 4 weeks prior to enrollment use of nasal steroids, nasal cromolyn or oral steroids
- •Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may compromise the quality
研究组 & 干预措施
Omalizumab
Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.
干预措施: Omalizumab (Drug)
Placebo
This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.
干预措施: Placebo (Drug)
结局指标
主要结局
The the Size of the 8 Late-phase Skin Response
时间窗: Baseline, 2-6 wks
Reduction in skin late phase size at 8 hours at the time of blood basophil hypo-responsiveness to allergen will be reduced compared to baseline.
次要结局
未报告次要终点
研究者
Sarbjit Saini
Associate Professor
Johns Hopkins University