NCT02570984进行中（未招募）2 期
Controlling and Preventing Asthma Progression and Severity in Kids
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- active asthma diagnosis
研究概览
简要总结
This trial is a randomized, double-blind, placebo controlled trial designed to test whether two years treatment of preschool children aged 2-3 years of age at high risk for asthma with omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2 year observation period off study drug.
详细描述
Prevention/ Disease modification of asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Months 至 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent/guardian must be able to understand and provide signed and dated written informed consent; he/she must also be able to communicate with study staff.
- •24-47 months of age at randomization
- •2-4 wheezing episodes in the past year
- •positive allergy to aeroallergen
- •first degree relative with history or current diagnosis of asthma or allergy
- •If is participating in a food immunotherapy treatment that is not part of a clinical trial, has been on an established maintenance regimen implemented continuously for a minimum of 2 months.
排除标准
- •>4 episodes of wheezing in the past year
- •Use of Step 5 or Step 6 therapy (ICS plus LABA ) at the time of enrollment (Visit 0).
- •Need for systemic corticosteroids or a hospitalization for respiratory symptoms within four weeks prior to screening.
- •Three or more courses of systemic corticosteroids for wheezing illnesses in the last year
- •More than four days of symptoms of wheezing, or tightness in the chest or cough in the past two weeks causing at least minimal limitation of activity
- •More than four days of albuterol treatment (for symptoms) in the past two weeks
- •More than one night of symptoms of wheezing, or tightness in the chest or cough causing sleep disruption in the past two weeks
- •More than one night of albuterol treatment (for symptoms) in the past two weeks
- •Prematurity (<34 weeks gestation)
- •Need for oxygen for more than 5 days in the neonatal period
- •History of intubation or mechanical ventilation for respiratory illness
- •Other significant medical conditions, including: major congenital anomalies, cystic fibrosis, chronic pulmonary diseases, bronchopulmonary dysplasia, thoracic surgery, history of tuberculosis, immunodeficiency (primary or secondary), seizure disorders
- •Expecting to relocate within 4 years of study initiation to a place which would make in-person clinical visits impossible
- •Deemed unable to adhere to study activities
- •Prior aeroallergen immunotherapy or use of biologics including anti-IgE
- •Prior IVIG or systemic immunosuppressant other than corticosteroids
- •History of hypoxic seizures during a wheezing episode
- •Total IgE outside of the omalizumab dosing range.
- •Enrolled in any clinical medication trial within the past 30 days.
- •With platelet counts < 150 x 109/L at the Screening Visit (V0)
- •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 impact the quality or interpretation of the data obtained from the study.
- •History of severe anaphylactic/anaphylactoid reactions from any cause
研究组 & 干预措施
Active
Active Comparator
omalizumab 0.016 mg/kg/IU total IgE
干预措施: Omalizumab (Drug)
Placebo
Placebo Comparator
looks like active drug
干预措施: Placebo (Drug)
结局指标
主要结局
active asthma diagnosis
时间窗: Final 12 months during 2 year observation period off study drug
questionnaire
asthma severity
时间窗: Final 12 months during 2 year observation period off study drug
questionnaire
次要结局
- number of positive new allergic sensitization(Final 12 months during 2 year observation period off study drug)
- decrease in number of wheezing episodes(Final 12 months during 2 year observation period off study drug)
研究者
Wanda Phipatanakul
Professor of Pediatrics
Harvard Medical School (HMS and HSDM)
研究点 (13)
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