A Multicentre, Open Label, Phase IIb Clinical Trial to Evaluate Safety, Tolerability and Efficacy of the Depigmented Modified Allergen Extract of Two Mites Mixes at 200 DPP/ml (DP/MG/14-1 Dermatophagoides Pteronyssinus / Lepidoglyphus Destructor and DP/MG/14-2 Dermatophagoides Pteronyssinus /Blomia Tropicalis) in Subjects With Allergic Rhinitis or Rhinoconjunctivitis, With Controlled Allergic Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 3
- 主要终点
- Subjects (%) suffering from immediate or delayed systemic grade 2 reactions
研究概览
简要总结
This is an open-label, non-controlled, non-randomised, prospective safety study in patients with rhinitis or allergic rhinoconjunctivitis, with controlled asthma, and clinically relevant sensitisation to dust mites from the Pyroglyphidae and Glycyphagidae families.
详细描述
The objective is to evaluate the safety and tolerability of the administration of two allergen extracts of dust mite mixtures at 200 DPP/ml (DP/MG/14-1 Dermatophagoides pteronyssinus / Blomia tropicalis and DP/MG/14-2 Dermatophagoides pteronyssinus / Lepidoglyphus destructor) using a rush build-up phase in patients with allergic rhinitis or rhinoconjunctivitis, with controlled asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided appropriately signed and dated written informed consent.
- •Men and women aged 18 years and 70 years of age at Visit
- •Has an FEV1 value 80% of predicted normal value at Visit
- •Individuals suffering from perennial allergic rhinitis or rhinoconjunctivitis moderate-severe for at least the preceding year, with controlled asthma, caused by double sensitization against Dermatophagoides pteronyssinus (DPT) and Lepidoglyphus destructor or Dermatophagoides pteronyssinus and Blomia tropicalis.
- •Patients sensitized to co-allergens such as tree pollen, grasses or weeds, fungi or animal epithelials cannot participate in the study if they are symptomatic.
- •If a female is of non-childbearing potential, the subject must be postmenopausal for at least 1 year or surgically sterile.
- •If a female is of childbearing potential, the subject must be non-lactating and non-pregnant and must correctly use an effective method of contraception during the study.
排除标准
- •Any contraindication for treatment with allergen specific immunotherapy.
- •Subjects with a previous history of anaphylaxis.
- •Patients with hospital admission due to asthma exacerbations within 1 year prior to V
- •Has uncontrolled asthma, according to Global Initiative for Asthma Guidelines (GINA 2010).
- •Acute or chronic infectious conjunctivitis.
- •Has acute or chronic inflammatory or infectious airways disease.
- •Has chronic structural diseases of the affected organ (e.g. eye, nose, lung).
- •History or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance.
- •Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism).
- •Has a severe uncontrolled disease that could increase the risk to the subjects while participating in the study, including but not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disord
研究组 & 干预措施
DP/MG/14-2
DP/MG/14-2: Depigmented modified allergen extract of D. pteronyssinus 50% / Depigmented, glutaraldehyde-polymerised L.destructor 50% (200DPP/mL) The administration regimen will consist of a rush build-up régimen and a follow up period
干预措施: DP/MG/14-2 (Biological)
DP/MG/14-1
DP/MG/14-1: Depigmented modified allergen extract of D. pteronyssinus 50% / Depigmented, glutaraldehyde-polymerised B. tropicalis 50% (200DPP/mL) The administration regimen will consist of a rush build-up régimen and a follow up period
干预措施: DP/MG/14-1 (Biological)
结局指标
主要结局
Subjects (%) suffering from immediate or delayed systemic grade 2 reactions
时间窗: Safety: local and systemic adverse reactions (EAACI classification) within 24 and 48 hours after the treatment.
Subjects (%) suffering from immediate or delayed systemic grade 2 reactions, according to EACCI 2006 classification, along the study
次要结局
未报告次要终点