Stop Exogenous Allergic Alveolitis (EAA) in Childhood: Healthy Into Adulthood - A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Prednisolone Treatment and Course of Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 7
- 主要终点
- Forced Vital Capacity (FVC).
研究概览
简要总结
Stop exogenous allergic alveolitis (EAA) or hypersensitivity pneumonitis in childhood: healthy into adulthood - a randomized, double-blind, placebo-controlled, parallel-group study to evaluate prednisolone treatment and course of disease.
The hypothesis of the study is that the treatment with placebo will not be inferior in terms of Forced Vital Capacity (FVC) improvement than treatment with systemic steroids after 6 months treatment.
详细描述
After an initial steroid pulse given to all patients, patients will be allocated to the two treatments, i.e., oral prednisolone and Placebo.
Experimental intervention: Placebo Control intervention: Prednisolone Duration of intervention per patient: 3 months Follow-up per patient: 3 months
Primary Objective:
To evaluate outcome of EAA at 6 months and compare the medium term treatment with systemic steroids or placebo.
Secondary Objectives:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly or previously diagnosed but not appropriately treated EAA in children, adolescents and young adults, aged between 3 and 25 years. The diagnosis of EAA must be confirmed by independent review of the findings by an expert panel and must be based on the presence of at least 4 of the following findings:
- •History of appropriate allergen exposure
- •Restrictive lung function (FVC < 80% predicted for age and FVC/FEV1 < 1) testing, if appropriate for age (usually > 5 y)
- •Positive serum precipitins for bird/fungus exposed to (other allergens have rarely, if every been demonstrated in children)
- •Lymphocytosis in BAL (> 20% of cells are lymphocytes)
- •HRCT showing the characteristic nodular, linear or reticular opacities, and ground glass pattern with increased attenuation.
- •Lung biopsy demonstrating lymphocytic alveolitis, bronchiolitis, and non-caseating histiocytic granulomatas.
- •Controlled allergen exposure followed by characteristic reaction, including fever, coughing, restriction on lung function, hypoxemia/desaturation at rest or with exercise
- •Unchanged inhaled steroids if on; if off, no plans to introduce them in the following 6 months
- •Agreement to home visit by independent study physician
排除标准
- •Contraindication for usage systemic steroids
- •Critically ill patients needing respiratory support
- •Non-compliance with medical treatments and interventions
- •Women with childbearing potential and not practicing a medically accepted contraception during the trial and a positive pregnancy test (serum or urine) before and at the end of the trial. Reliable contraception are systematic contraceptives (oral, implant, injection) and diaphragm or condoms with spermicide.
- •Pregnancy and lactation.
- •Participation in another trial for EAA during the last 4 weeks or not beyond the time of 4 half-lives of the medication used. In the unlikely event a subject is already in another clinical study but not for EAA, that study must be stopped and the subject may be treated according to this protocol; a latency time between the two studies does not appear reasonable, as acute intervention is necessary for EAA. Treatment may be best done in the frame work of this protocol.
研究组 & 干预措施
Placebo
Capsules of placebo will be taken for 3 months, same schedule as verum.
干预措施: Placebo (Drug)
Prednisolone
Oral prednisolone, anticipated dose:
first month 0.5 mg/kg bw/d, second month 0.25 mg/kg bw/d, and third month 0.125 mg/kg bw/d in a single morning dose.
Individual capsules will be prepared using rounded dose.
干预措施: Prednisolone (Drug)
结局指标
主要结局
Forced Vital Capacity (FVC).
时间窗: 6 months
The relative change from baseline through month 6 compared to change from placebo of FVC.
次要结局
- Forced Vital Capacity (FVC)(3 months)
研究者
Matthias Griese
Prof. Dr. med.
Ludwig-Maximilians - University of Munich