Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Dermatophagoides Pteronyssinus.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Number and Seriousness of Both Local and Systemic Adverse Reactions
研究概览
简要总结
Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study was to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations in patients allergic to Dermatophagoides pteronyssinus.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with allergic rhinoconjunctivitis with or without asthma against DPT during a minimum of 1 year prior to study participation.
- •Patients must sign the informed consent form.
- •Patients must be between 18 and 60 years of age.
- •Patients who obtained a prick test result greater or equal to 3 mm diameter and a specific IgE greater or equal to class 2 (CAP/PHADIA) to DPT.
- •Patients will preferably be monosensitized to DPT. In the case of polysensitized patients they can only be included if other sensitizations are caused by seasonal allergens whose pollination do not overlap with the study period.
- •Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0
- •Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active
排除标准
- •Stable and continued use of medication for allergic pathology during 2 weeks prior to inclusion.
- •Patients sensitised to other perennial allergens clinically relevant and with specific IgE levels greater or equal to class 2 CAP/PHADIA.
- •Patients who received immunotherapy in the previous 5 years for DPT or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
- •Patients with severe asthma or FEV1 minor than 70% or asthma requiring inhaled or systemic corticoid treatment at the time of study entry or within 8 weeks prior to treatment initiation.
- •Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
- •Patients with a previous history of anaphylaxis
- •Patients with chronic urticaria
- •Patients with unstable angina
- •Patients with uncontrolled hypertension
- •Patients with clinically significant arrythmias
- •Patients with neoplasia
- •Patients with clinically relevant malformations of the upper respiratory tract.
- •Other chronic or immunological disease that could interfere with the assessment of the investigational product or that could generate any additional risk for the patients
- •Patients who have participated in another clinical trial within 3 month prior to enrolment.
- •Patients under treatment with tricyclic antidepressives, psychotropics beta-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
- •Female patients who are pregnant or breast-feeding or women of childbearing potential that do not agree to use an appropriate contraception method during the study if they are sexually active, if they have not been surgically sterilised or present any other incapacity to bear
- •Patient who does not attend the visits
- •Patient's lack of collaboration or refusal to participate
研究组 & 干预措施
Group A active
6 administrations and 5 weeks duration
- Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
- Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
干预措施: subcutaneous immunotherapy with DPT extract (Biological)
Group A placebo
6 administrations and 5 weeks duration
- Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
- Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
干预措施: Subcutaneous depot placebo (Biological)
group B active
8 administrations and 7 weeks duration
- Vial 1: 0.2 ml at 1 week intervals
- Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
- Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
干预措施: subcutaneous immunotherapy with DPT extract (Biological)
Group B placebo
8 administrations and 7 weeks duration
- Vial 1: 0.2 ml at 1 week intervals
- Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
- Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
干预措施: Subcutaneous depot placebo (Biological)
Group C active
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
- Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
- Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
- Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
- Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
干预措施: subcutaneous immunotherapy with DPT extract (Biological)
Group C placebo
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
- Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
- Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
- Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval
- Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
干预措施: Subcutaneous depot placebo (Biological)
结局指标
主要结局
Number and Seriousness of Both Local and Systemic Adverse Reactions
时间窗: From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )
The primary end points were the number of ARs and the severity of local and systemic ARs (SARs) to SCIT administration. Proportions were compared between study arms. The tolerability of SCIT was evaluated by early and late local reactions (i.e., local swelling and redness) and systemic reactions after each injection (any symptoms from organs distant from the location of the injection). Reactions were classified depending on the severity and onset of the reaction, according to the EAACI classification (Alvarez-Cuesta 2006).
次要结局
- Immunoglobulin Levels (IgE Specific) Active Versus Placebo(Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks))
- Immunoglobulin Levels (IgG 4) Active Versus Placebo(Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks))
- Immunoglobulin Levels (IgG Total) Active Versus Placebo(Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks))