A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With an Alum.-Adsorbed Allergoid Preparation of House Dust Mite (D. Pteronyssinus) in Patients With Allergic Bronchial Asthma, Rhinitis, Rhinoconjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Inhalative dose of fluticasone propionate
研究概览
简要总结
The trial is performed to assess efficacy and safety of the Allergopharma house dust mite allergoid in bronchial asthma.
详细描述
The rationale for the present study was to demonstrate clinical efficacy and tolerability compared to placebo in a phase III clinical study of pivotal character with a representative number of patients suffering from fully reversible asthma +/- allergic rhinitis. This condition is present in paediatric and adult patients with a shorter history of GINA II and III asthma, who were investigated in this study.
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 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bronchial asthma
- •Requirements for inhaled corticosteroid
- •Positive skin prick test to house dust mite
- •Positive radioallergosorbent test (RAST) to house dust mite
- •Positive provocation test result to house dust mite
排除标准
- •Serious chronic diseases
- •Other perennial allergies
研究组 & 干预措施
Placebo
Placebo was given the same way as a subcutaneous (just under the skin) injection. Children received lifestyle counselling.
干预措施: Placebo (Drug)
Acaroid
The drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses.
干预措施: Acaroid (Biological)
结局指标
主要结局
Inhalative dose of fluticasone propionate
时间窗: After 2 years
The primary endpoint variate was the change of inhalative dose of fluticasone propionate needed to ensure asthma control according to GINA recommendation.
次要结局
- Pre-bronchodilator morning peak flow(After 2 years)