NCT01087710已完成2 期
Effect of Novel Medical Food on Reducing the Frequency and Severity of Asthma Symptoms and Airway Hyper-responsiveness in Children With Mild to Moderate Persistent Asthma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- asthma free days
研究概览
简要总结
To determine the effect of medical food on reducing asthma symptoms in asthmatic children.
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
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female children who have had mild to moderate persistent asthma for at least 1 year and are between 6 and 14 years of age, and not currently being treated with steroids are eligible.
- •Each subject also has to have:
- •Subject is off of controller therapy 4 wks preceding visit
- •Mild to moderate persistent asthma
- •Methacholine responsiveness with an FEV1 PC20
- •Able to perform reproducible spirometry
- •Verbal assent in addition to consent
- •History of prior clinical varicella or varicella vaccine.
- •Nonsmoker in past year.
排除标准
- •Asthma symptoms and/or albuterol use consistent with severe persistent asthma during the run-in period.
- •Subject with FEV1 < 80% predicted at visit 1 or FEV1 < 70% predicted at visit
- •Two or more hospitalizations for asthma in the past year.
- •Subject has received oral, nasal, inhaled, or IM corticosteroids during the preceding month.
- •Subject has received leukotriene modifiers, theophylline derivatives, or mast cell stabilizers for asthma within 4 weeks before visit 1
- •Subject is receiving one or more of the following medications:
- •Astemizole prior to 3 months of visit 1
- •Oral, inhaled or parenteral corticosteroids prior to 4 weeks of visit 1
- •Cromolyn, antimuscarinics, cimetidine, metoclopramide, phenobarbital, phenytion, terfenadine, loratadine, or anticholingeric agents prior to 2 weeks of visit
- •Theophylline prior to 4 weeks of visit 1
- •Subject with active upper respiratory tract infection prior to 4 weeks before visit 1
- •Subject with acute sinus disease requiring antibiotic treatment within 1 week before visit
- •Subject with an emergency department treatment for asthma within 1 month, prior intubation for asthma, or hospitalization for asthma within 3 months
- •Subject has known bleeding disorder and/or is on medication known to have significant anticoagulant effects.
- •Subject has known hypersensitivity to any of the ingredients
- •Subject is taking either pill, powder, or liquid forms of nutritional and/or health food supplements within the past 4 weeks prior to visit
- •Subject unable to tolerate or unwilling to take the full dose of the nutritional study formulas
- •Cystic fibrosis or any other chronic lung disease other than asthma.
- •Subject having gastroesophogeal reflux undergoing medical treatment
- •Significant medical illness other than asthma that could require oral corticosteroids during the study.
- •Subject is receiving allergen hyposensitization therapy other than an established maintenance regimen
- •Subject has received IV globulins or immunosuppressants.
- •Subject is known to be human immunodeficiency virus (HIV) positive.
- •Pregnancy or lactation.
- •If of child bearing potential, failure to practice abstinence or use of an acceptable birth control method.
- •Subject is morbidly obese
结局指标
主要结局
asthma free days
时间窗: 12 weeks
次要结局
- reduction of airway hyper-responsiveness(12 weeks)
- time to the first asthma exacerbation(12 weeks)
- respiratory function (spirometry)(12 weeks)
- need for rescue for exacerbations of asthma symptoms.(12 weeks)
研究者
研究点 (2)
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