Double-Blind, Placebo-Controlled Phase 2 Study to Assess Safety and Efficacy of Chinese Herbal Therapy and Multiple Food Allergen Oral Immunotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Sustained unresponsiveness to cumulative dose of 4,444 mg protein
研究概览
简要总结
The purpose of this study is testing the use of Enhanced-Butanol purified-Food Allergy Herbal Formula-2 (E-B-FAHF-2) Chinese herbal therapy in combination with multi-food oral immunotherapy (OIT) and Xolair® (Omalizumab) to help children and adults who are allergic to foods be able to safely tolerate food allergens. Specifically in this protocol, the food allergens are milk, egg, peanut, almond, cashew, hazelnut, walnut, sesame, and/or wheat. Omalizumab is considered an investigational drug for the treatment of food allergies in children and adults. Investigational means it has not been approved by the Food and Drug Administration (FDA) for use in the U.S. The researchers hope to learn whether the addition of Chinese herbal therapy (E-B-FAHF-2) can improve the outcome of sustained unresponsiveness (which is the ability to consume a food allergen and pass an oral food challenge after being off treatment for 3 months) as compared to placebo (i.e. subjects with OIT/Omalizumab + herbal vs. OIT/Omalizumab + placebo), and will help adults and children be able to safely ingest the foods they are allergic to.
详细描述
Prior studies have shown that this Chinese herbal formulation is safe and well-tolerated in food allergic individuals. While oral immunotherapy (OIT) can lead to desensitization, it remains uncertain whether this treatment can lead to lasting protection. Therefore, this study aims to use the Chinese herbal formula in combination with OIT to determine whether sustained protection can be achieved. All subjects will receive multi-allergen OIT, along with a 4 month course of omalizumab to provide added safety for the initial dose escalation and build up phases. Subjects will be randomized to receive active Chinese herbal formula or placebo. Subjects will be treated with OIT for 2 years and then food challenges will be performed to assess for desensitization. For those who achieve desensitization, all treatments will be discontinued and food challenges will be performed 3 months later to assess for sustained unresponsiveness.
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)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 through 40 years
- •At least one of the following for each of the 3 study allergens: serum immunoglobulin E (IgE) >4000 U/L or skin -prick test >6mm
- •dose limiting symptoms at a cumulative dose of <=444 mg protein for 3 allergens as screening double-blind, placebo-controlled food challenge
- •use of an effective method of contraception by females of child-bearing potential
- •ability to ingest oat or corn with no allergic reaction
排除标准
- •If baked milk or egg are tolerated (assessed by clinical report), then milk or egg may not be included as a study allergen
- •Any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, and serious ventricular arrhythmias
- •History of other chronic disease requiring therapy (other than asthma, atopic dermatitis, or rhinitis)
- •History of eosinophilic gastrointestinal disease
- •Current participation in any other interventional study
- •Investigational drug use within 90 days
- •Subject is on build-up phase of any allergen immunotherapy (prior to maintenance dosing)
- •Current uncontrolled moderate to severe asthma as defined by:
- •Forced Expiratory Volume-1 (FEV1) value <80% predicted or any clinical features of moderate or severe persistent asthma baseline severity (as defined by the 2007 NHLBI Guidelines) and greater than high daily doses of inhaled corticosteroids (as defined for children and adults using dosing tables from the 2007 NHLBI Guidelines).
- •Use of steroid medications in the following manners: history of daily oral steroid dosing for >1 month during the past year, having 1 burst or steroid course within the past 6 months, or having >1 burst oral steroid course within the past 12 months.
- •Asthma requiring >1 hospitalization in the past year for asthma or >1 Emergency Department (ED) visit in the past 6 months for asthma.
- •Use of systemic steroid medications (Intravenous, Intramuscular or oral) for indications other than asthma for > 3 weeks within the past 6 months
- •Inability to discontinue antihistamines for the initial day of escalation, skin testing or DBPCFC
- •Use of Xolair® (omalizumab) within the past 6 months
- •Known sensitivity to Xolair® (omalizumab) or to the class of study drugs
- •Body weight more than 90 kg, or subjects with weight-IgE combination that yields a dose requirement greater than 600 mg dosing
- •Use of beta-blockers (oral), Angiotensinogen converting enzyme (ACE) inhibitors, angiotensin-receptor blockers or calcium channel blockers
- •Pregnancy or lactation
- •Inability to swallow placebo capsules
- •Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements
研究组 & 干预措施
Active Comparator::Chinese Herbal Medication
Interventions:
- Drug: Chinese Herbal Medication (E-B-FAHF-2), dose level was determined using the subject's weight at the screening visit (>20-30 kg = 5 capsules daily, >30-70 kg = 8 capsules daily, and >70 kg = 10 capsules daily)
干预措施: Drug: Chinese Herbal Medication (Drug)
Placebo Comparator: Placebo
Interventions:
- Drug: Placebo. Placebo capsules were identical in appearance but contained corn starch
- Drug: Omalizumab. Omalizumab was dosed as per the product insert
- Drug: Multi OIT. An initial rush dose to a maximum of 250 mg of protein of each allergen (total 270 mg of protein) and up-dosing every 2 weeks until the maintenance dose of 1000mg was reached.
干预措施: Drug: Placebo (Drug)
结局指标
主要结局
Sustained unresponsiveness to cumulative dose of 4,444 mg protein
时间窗: 29 months
Sustained unresponsiveness evaluated by the absence of dose-limiting symptoms to a cumulative dose of 4,444 mg protein.
次要结局
- Desensitization to 4444mg protein(26 months)
- High level desensitization to 7444mg protein or higher(26 months)