A Biomarker-Based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Children With Asthma and/or Perennial Allergic Rhinitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 5
- 主要终点
- Change in German Cockroach-Specific Serum IgE Over Time
研究概览
简要总结
This trial is a follow-up study of the ICAC-12 Phase I/II trial (NCT00829985), and is designed to study biomarkers of the immune response to allergen immunotherapy and the safety of this therapy in a pediatric population.
详细描述
Over the past two decades, scientific evidence has shown that the combination of cockroach allergy and cockroach exposure is one of the most important factors contributing to the dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a major goal of the National Institute of Allergy and Infectious Diseases (NIAID) Inner City Asthma Consortium (ICAC) is ultimately to conduct a large multi-center trial of cockroach sublingual immunotherapy (SLIT) in inner-city asthma. As a step toward achieving this goal, ICAC is conducting a clinical trial comparing two doses of glycerinated German cockroach (Blattella germanica) allergenic extract to placebo, administered under the tongue (sublingual).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a history of perennial allergic rhinitis, asthma, or both, before study entry. For those with asthma:
- •a diagnosis of asthma will be defined as a report by the participant that they have had a clinical diagnosis of asthma made by a physician over a year ago
- •the participant's asthma must be well controlled as defined by: ii. a forced expiratory volume at one second (FEV1) greater than or equal to 80% predicted value with or without controller medication ii. albuterol use for no more than 3 days per week in each of the previous 2 weeks for asthma symptoms (not including exercise prophylaxis)
- •Are sensitive to German cockroach (Blattella germanica) as documented by a positive (>/=3 mm greater than negative control) skin prick test result and detectable German cockroach specific IgE (>/=0.35 kUA/L)
- •Have no known contraindications to therapy with glycerinated German cockroach allergenic extract or placebo
- •Parent or legally authorized representative (LAR) of child is willing to sign the written Informed Consent prior to initiation of any study procedure
排除标准
- •Are pregnant or lactating. Females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception)
- •Cannot perform spirometry or peak flow at screening
- •Have an asthma severity classification at recruitment of severe persistent, using the National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
- •requires a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid
- •have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months
- •have been treated with depot steroids within the last 12 months
- •have been hospitalized for asthma within the 6 months prior to recruitment
- •have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment
- •Do not have access to a phone (needed for scheduling appointments)
- •Have received allergen immunotherapy in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study
- •Have previously been treated with anti-IgE therapy within 1 year of recruitment
- •Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study
- •Have in the last 3 months prior to recruitment experienced on average >/=1 day per week any of the symptoms below:
- •nausea or vomiting
- •abdominal pain or cramps severe enough to interfere with daily activities (excluding those associated with menstruation).
- •Refuse to sign the Epinephrine Auto-injector Training Form
- •Participants who meet any of the following criteria are not eligible for enrollment and may not be reassessed. Participants are ineligible if they:
- •Do not primarily speak English
- •Plan to move from the area during the study period
- •Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher
- •Have unstable angina, significant arrhythmia, uncontrolled hypertension, history of autoimmune disease, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the investigational agent or pose additional risk to the patient (e.g., gastrointestinal disease, gastroesophageal reflux disease, chronic infections, scleroderma, hepatic, and gallbladder disease)
- •Are using tricyclic antidepressants or beta-adrenergic blocker drugs (either oral and/or topical route[s] of administration)
研究组 & 干预措施
Cockroach Sublingual Immunotherapy (SLIT) - Low Dose
Glycerinated German cockroach (Blatella germanica) allergen extract administered sublingually with a maximally tolerated dose of 420 microliters daily
干预措施: Cockroach Sublingual Immunotherapy (SLIT) - Low Dose (Biological)
Placebo
Placebo administered sublingually not to exceed the maximally tolerated dose of either 1.) 420 microliters daily (placebo - low dose randomization) or 2.) 840 microliters twice daily (placebo - high dose randomization)
干预措施: Placebo (Other)
Cockroach Sublingual Immunotherapy (SLIT) - High Dose
Glycerinated German cockroach (Blatella germanica) allergen extract administered sublingually with a maximally tolerated dose of 840 microliters taken twice daily
干预措施: Cockroach Sublingual Immunotherapy (SLIT) - High Dose (Biological)
结局指标
主要结局
Change in German Cockroach-Specific Serum IgE Over Time
时间窗: Baseline through 3 months of treatment
Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.
次要结局
- Change in German Cockroach-Specific Serum IgG Over Time(Baseline through 3 months of treatment)
- Change in German Cockroach-Specific Serum IgG4 Over Time(Baseline through 3 months of treatment)
- Change in IgE Fragment Antibody Binding (FAB) Activity Over Time(Baseline through 3 months of treatment)
- Percent of Participants With the Occurrence of Adverse Events (AEs)(Participant enrollment to end of study (up to 3 months post-baseline))