A Prospective, Multicenter, Randomized, Controlled, Open Trial, Parallel Groups (1: 1), With Subcutaneous Polimerized Mix (100/100), in Patients With Rhinoconjunctivitis Sensitized to the Following Combination of Pollen: Timothy Grass and Olea Europaea, and Asministered by Different Schedules
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- Number and severity of adverse reactions as a measure of safety and tolerabitity
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 polimerized (100/100) mixture of pollens: Olea europaea and Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
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
- None
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 must sign the Informed Consent Form.
- •Patients must be between 18 and 60 years of age.
- •Patients with seasonal allergic rhinoconjunctivitis produced by Phleum pratense and Olea europaea during at least 2 years prior to participating in the study. Although the pathology being studied is allergic rhinoconjunctivitis, patients who have concomitant mild or moderate asthma may be included.
- •Patients who have had a skin prick test result ≥ 3 mm in diameter against Phleum pratense and Olea europaea.
- •Patients who have specific IgE ≥ class 2 (CAP/PHADIA) to Phleum pratense and Olea europaea.
- •Patients will preferably be polysensitized to Phleum pratense. Polysensitized patients to otherallergenic sources may only be included in the study if their other sensitizations are produced by:
- •Overlapping seasonal pollens which are cross-reactive with Phleum pratense and Olea europaea.
- •Pollens whose seasons do not overlap with Phleum pratense or Olea europaea and which are not expected to produce symptoms during the study period.
- •Other allergens which are not expected to produce symptoms during the study period.
- •Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
- •Furthermore, women of child-bearing potential must agree to use adequate contraceptive methods during this study if they are sexually active.
排除标准
- •Patients who received immunotherapy in the previous 5 years for Phleum pratense and 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.
- •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
研究组 & 干预措施
One day schedule
Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in one day schedule. The maintenance dose (0.5 mL) is reached in one day.
干预措施: allergovac polimerized (100/100) (Biological)
Rapid schedule
Allergovac polimerized with a mixture of 2 pollen extracts (100:100): Olea europea and Phleum pratense, administered in a rapid Schedule.The initation phase includes 3 weekly increasing doses till the maintenance dose of 0.5 mL is reached.
干预措施: allergovac polimerized (100/100) (Biological)
结局指标
主要结局
Number and severity of adverse reactions as a measure of safety and tolerabitity
时间窗: Across 12-15 weeks treatment period
次要结局
- Skin reactivity changes from baseline(At baseline and 1 week after last administered dose)
- Immunoglobulin changes from baseline(At baseline and 1 week after last administered dose)