NCT03462030已完成2 期
Phase II Study of Baked Milk Oral Immunotherapy for the Treatment of Cow's Milk Allergy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
研究概览
简要总结
The purpose of this study is to determine whether baked milk oral immunotherapy is safe in the treatment of cow's milk allergy.
详细描述
This study is designed to assess the safety of baked milk oral immunotherapy among patients who are milk allergic and who do not pass a baked milk challenge.
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
Placebo controlled
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all of the following criteria are eligible for enrollment as study participants, including participants who:
- •Are age 3-18 years, either sex, any ethnicity or race
- •Provide signed informed consent by parent or legal guardian and informed assent if applicable
- •Have a history of symptomatic reactivity to cow's milk (i.e. eczema, urticarial, upper or lower respiratory symptoms, gastrointestinal disturbances, rash, oral symptoms)
- •Have a skin prick test positive to milk (diameter of wheal 3 mm ≥ negative control) and serum milk-specific immunoglobulin E (IgE) level >5 kilo Units (kU)/L within the past 6-12 months
- •Have a positive reaction to a cumulative dose of ≤444 mg of baked milk powder in the initial qualifying double blind placebo-controlled food challenge.
- •Use an effective method of contraception by females of childbearing potential to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
- •Have self-injectable epinephrine available at all times
排除标准
- •Patients who meet any of these criteria are not eligible for enrollment as study participants, including participants who:
- •Have a history of severe anaphylaxis resulting in hypotension, neurological compromise, or mechanical ventilation
- •Have a history of intubation related to asthma
- •Tolerate more than 444 mg of baked milk powder at the initial qualifying double blind placebo controlled food challenge.
- •Allergy to placebo ingredients or reacts to any dose of placebo during the qualifying oral food challenge.
- •Poor control of atopic dermatitis
- •Are unable to tolerate at least 3 mg of baked milk protein on dose escalation day
- •Are pregnant or lactating
- •Have severe asthma defined by 2007 National Heart Lung and Blood Institute (NHLBI) Criteria Steps 5 or 6
- •Have severe or poorly controlled asthma defined by with any of the following criteria:
- •Forced expiratory volume in 1 second (FEV1) <80% of predicted
- •Inhaled corticosteroid dosing dosing of >500 mcg daily of fluticasone (or equivalent inhaled corticosteroids based on NHLBI dosing chart) or
- •≥ 1 hospitalization in the past year for asthma or
- •> 1 emergency department visit in the past 6 months for asthma
- •Use of steroid medications (oral steroids, such as prednisone or Medrol, steroid injections, such as Kenalog, or intravenous or oral corticosteroid burst) in the following manners: History of daily oral steroid dosing within 4 weeks prior to baseline visit or for > 1 month during the past year or >2 burst oral steroid courses in the past 6 months.
- •Are unable to discontinue antihistamines for 5 days for long acting and 3 days for short acting prior to skin testing or food challenges
- •Are receiving omalizumab, mepolizumab, beta- blocker, angiotensin-converting-enzyme inhibitor (ACE-I), angiotensin-receptor blockers, calcium channel blockers, or tricyclic antidepressant therapy
- •Have used immunomodulatory therapy (not including corticosteroids) or biologic therapy within the past year
- •Have participated in any interventional study for treatment of a food allergy in the past 6 months
- •Are on 'build up phase' of environmental allergen immunotherapy. Subjects tolerating maintenance allergen immunotherapy can be enrolled.
- •Have a history of eosinophilic esophagitis in the past 3 years
- •Have a chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
- •Have used an investigational drug within 90 days or plan to use an investigational drug during the study period
- •Severe reaction at initial double blind placebo controlled food challenge, defined as:
- •Life-threatening anaphylaxis
- •Requiring overnight hospitalization
研究组 & 干预措施
Baked Milk Immunotherapy
Experimental
Subjects will receive baked milk oral immunotherapy with baked non-fat cow's milk powder as the intervention. Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.
干预措施: Baked non-fat cow's milk powder (Drug)
结局指标
主要结局
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
时间窗: 1 year
Adverse events will be recorded per CTCAE version 4.0. Events per dose on baked milk oral immunotherapy will be compared to adverse events per dose on placebo. Data will be collected over the first year of treatment. Analysis of cumulative adverse reactions per dose of oral immunotherapy or placebo will be performed at the end of year 1.
次要结局
- Proportion of Subjects Who Are Able to Tolerate 4 Grams of Baked Milk Protein After One Year of Treatment(1 year)
- Number of Subjects Who Are Able to Tolerate 2 Grams of Unheated Milk Protein After 2 Years of Treatment(2 years)
- Change in Maximum Tolerated Dose of Baked Milk(Baseline, 1 year and 2 years)
- Change in Milk-specific IgE Level(Baseline and up to year 2)
- Change in Milk-specific IgG4 Level(Baseline and up to year 2)
- Change in Milk Skin Prick Test Responses(Baseline and up to year 2)
- Change in Quality of Life as Assessed by the Food Allergy Questionnaire(Baseline and up to year 2)
研究者
研究点 (1)
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