NCT02849210已完成1 期
A Phase I Multicenter, Open Clinical Trial With Subcutaneous Immunotherapy in Depot Presentation in Patients With Rhinoconjuncitivis Sensitized to Olea Europaea
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 6
- 主要终点
- Number and severity of adverse reactions as a measure of Safety and tolerability
研究概览
简要总结
The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with Olea europaea pollen extract in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity
详细描述
An study conducted througout Spain with 4000 allergic patients (Alergoloógica 2005) showed that 47% of patients with rhinoconjuncitivits and 51% of asthmatic patients were sentitized to olive pollen. This gives us an idea of the importance of this allergen sensitization in Spain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must sign the informed consent form.
- •Patients must be between 18 and 60 years of age.
- •Patients with seasonal allergic rhinoconjunctivitis against Olea europea during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild concomitant asthma is allowed.
- •Patients who obtained a prick test result ≥ 3 mm diameter to Olea europaea Positive and negative control of the test should give consistent results.
- •Patients with specific immunoglobulin E ≥ class 2 (CAP/PHADIA) to Olea europaea.
- •Patients sensitized to Olea europaea with clinically relevant symptoms in which treatment with Olea europea 100% vaccine is indicated.
- •Patients who met all windows of treatment described in the protocol for both, treatment and study procedures.
- •Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit
- •Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active.
排除标准
- •Patients who received immunotherapy in the previous 5 years for Olea europaea or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
- •Patients with severe asthma or forzed expiratoy volumen in 1 second FEV1< 70% even if the are pharmacologically controlled .
- •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.
- •Polisensitized patients to other inhalant allergens besides Olea europaea, if in the judgment of the investigator may present symptoms clinically relevant to those other airborne allergens while participating in this study
- •Patients with a previous history of anaphylaxis
- •Patients with chronic urticaria,
- •Patients with moderate to severe atopic dermatitis
- •Patients who have participated in another clinical trial within 3 month prior to enrolment.
- •Patients under treatment with tricyclic antidepressives, phenothiazines , β-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
- •Female patients who are pregnant or breast-feeding
- •Patient who does not attend the visits
- •Patient's lack of collaboration or refusal to participate.
研究组 & 干预措施
Allergovac depot
Experimental
Allergovac depot with Olea europaea pollen extract
干预措施: Allergovac depot with Olea europaea pollen extract (Biological)
结局指标
主要结局
Number and severity of adverse reactions as a measure of Safety and tolerability
时间窗: 17 weeks treatment period
次要结局
- Immunoglobulin changes from baseline(At baseline and 1 week after last administered dose)
- Cutaneous reactivity changes from baseline(At baseline and 1 week after last administered dose)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
1 期
A Multicenter, Open Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Parietaria JudaicaRhinoconjunctivitisNCT02477917Roxall Medicina España S.A51
已完成
1 期
A Trial With Subcutaneous Immunotherapy (SCIT) in Patients With Rhinoconjunctivitis Sensitized to Olea Europaea and Phleum PratenseRhinoconjuntivitisNCT02849249Roxall Medicina España S.A52
已完成
1 期
A Study to Evaluate ICP-022 in Patients With R/R Mantle Cell Lymphoma (MCL)Mantle Cell LymphomaNCT03494179Beijing InnoCare Pharma Tech Co., Ltd.106
已完成
1 期
A Study of DNA Vaccine With Electroporation for the Prevention of Disease Caused by H1 and H5 Influenza VirusHealthyNCT01405885Inovio Pharmaceuticals116
已完成
1 期
Tuberculosis Vaccine in Healthy Indian AdultsTuberculosisNCT06438978Bharat Biotech International Limited30