Treatment of Ragweed-Allergic Asthma With an Immunostimulatory Drug
Asthma Immunotherapy With a Ragweed Allergen Immunostimulatory Sequence Conjugate
研究概览
地位
详细说明
Ragweed allergy is a common trigger of asthmatic flare-ups in people with asthma. Individuals with ragweed allergy suffer increased asthma symptoms during the fall allergy season, which generally runs from August to November. These flare-ups can significantly impact an asthma patient's quality of life. AIC is an investigational medicine that combines special DNA sequences that can modify the way the immune system responds. In AIC, these sequences are linked to a piece of the ragweed pollen molecule (known as Amb a 1) that causes hay fever symptoms. Injections of AIC have been shown to change the way the immune system responds to ragweed pollen in both animals and humans in a way that may lead to reduced hay fever symptoms.
In a previous study, AIC was safe and well tolerated, and patients exhibited a decrease in allergy symptoms lasting up to 2 years after treatment on average. This study will evaluate whether short-term use of AIC during the spring can cause long-term immune tolerance to ragweed, reduce asthma symptoms, and decrease use of asthma medications for future allergy seasons.
During the 2007 fall ragweed allergy season, participants will be observed and be asked to keep a diary of their asthma symptoms and medication use. In the spring of 2008, participants will be randomly assigned to receive six weekly doses of either the experimental medicine or placebo. Participants will be observed again for the 2008 fall ragweed season. Another series of three weekly doses of the assigned study treatment will be given in spring 2009, with observation through the 2009 fall ragweed allergy season and possibly the 2010 season. During the observation periods, participants will be asked to track their asthma symptoms and medication use and report this information to study staff. Study visits will be weekly during the spring and biweekly during the ragweed season, with a maximum of 16 visits per year. Allergy and lung tests as well as blood and urine collection will occur at selected study visits; these tests are designed to measure the participants' immune response.
研究类型
注册
阶段
- 阶段2
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21224
- Johns Hopkins University
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Ohio
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Cincinnati、Ohio、美国、452323
- Bernstein Clinical Research Center, University of Cincinnati
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Columbus、Ohio、美国、43235
- Optimed Research, Ohio State University
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Pennsylvania
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Hershey、Pennsylvania、美国、71033
- Pennsylvania State University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- History of asthma
- History of asthma medication use during the 2005 fall ragweed season
- Suspected ragweed allergy
- Positive laboratory tests for ragweed allergy
Exclusion Criteria:
- Received immunotherapy for ragweed or other allergens within the 5 years prior to study entry
- Received anti-IgE (omalizumab) within the year prior to study entry
- 3 or more courses of oral corticosteroids for asthma within the year prior to study entry
- Inpatient hospitalization for asthma within the 5 years prior to study entry
- History of respiratory failure or intubation for asthma
- Smoking within the 6 months prior to study entry
- Greater than 5 pack/year history of smoking
- Clinically significant acute or chronic illness
- Chronic immunodeficiency
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
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Change in average daily asthma medication use between the 2007 and 2008 ragweed seasons
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次要结果测量
结果测量 |
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Effect of AIC on selected secondary clinical outcome measures
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safety of AIC in this population
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mechanisms through which AIC may induce tolerance to ragweed
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合作者和调查者
调查人员
- 学习椅:David Broide, MD、University of California, San Diego
- 首席研究员:Peter Creticos, MD、Johns Hopkins University
出版物和有用的链接
一般刊物
- Simons FE, Shikishima Y, Van Nest G, Eiden JJ, HayGlass KT. Selective immune redirection in humans with ragweed allergy by injecting Amb a 1 linked to immunostimulatory DNA. J Allergy Clin Immunol. 2004 Jun;113(6):1144-51. doi: 10.1016/j.jaci.2004.03.003.
- Tulic MK, Fiset PO, Christodoulopoulos P, Vaillancourt P, Desrosiers M, Lavigne F, Eiden J, Hamid Q. Amb a 1-immunostimulatory oligodeoxynucleotide conjugate immunotherapy decreases the nasal inflammatory response. J Allergy Clin Immunol. 2004 Feb;113(2):235-41. doi: 10.1016/j.jaci.2003.11.001.
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Amb a 1-immunostimulatory oligodeoxyribonucleotide conjugate (AIC)的临床试验
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ALK-Abelló A/S完全的