Clinical Efficacy and Mucosal/Systemic Antibody Response Changes After Sublingual Immunotherapy in Mite-allergic Children in a Randomized Double-blind, Placebo-controlled Study in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Change from Baseline in Symptom and Medication Scores at 12 months
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody response changes after SLIT using house dust mite allergen with or without bacterial extracts in mite-allergic children.
详细描述
Patients with allergic rhinitis with or without asthma were selected for a randomized double-blind, placebo-controlled trial and distributed into three groups: DPT (Dpt allergen extract, n=34), DPT+MRB (Dpt allergen plus mixed respiratory bacterial extracts, n=36), and Placebo (n=32). Clinical evaluation and immunological analyses are being carried out before and after 12 and 18 months of treatment, including rhinitis/asthma symptom and medication scores, skin prick test (SPT) to Dpt, and measurements of Dpt-, Der p 1-, Der p 2-specific serum IgE, IgG4, IgG1 and -specific salivary IgA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of allergic rhinitis
- •Positive skin test to Dermatophagoides pteronyssinus total extract
- •Positive serum levels of specific IgE to D. pteronyssinus extract
排除标准
- •Previous allergen immunotherapy
- •Use of antihistamines 1 week or topical corticosteroid up to 3 weeks prior to skin prick test
- •Long term use of systemic corticosteroid.
- •Airway infection 30 days prior to the selection.
- •Children with severe asthma, malignant, cardiovascular or autoimmune diseases, under chemotherapy or immunosuppressor therapy.
- •Users of cigarette smoke
- •Presence of severe skin lesions
结局指标
主要结局
Change from Baseline in Symptom and Medication Scores at 12 months
时间窗: Baseline and 12 months
For clinical evaluation will be used a questionnaire determining the symptom and medication scores.
次要结局
- Change from Baseline in Specific Antibody Levels.(Baseline, 12 months and 18 Months)
研究者
Ernesto Akio Taketomi
Principal Investigator
Federal University of Uberlandia