Prospective Observational Study to Evaluate the Efficacy and Safety of Treatment With "Allergovac Poliplus" in Polysensitized Patients With Allergic Rhinitis/Rhinoconjunctivitis, With or Without Associated Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 10
- 主要终点
- Combined Symptoms and Medication Score (CSMS)
研究概览
简要总结
This is an observational prospective multicenter clinical study, to evaluate the efficacy and safety of the treatment with Allergovac Poliplus subcutaneous immunotherapy (SCIT) with a mixture of 2 allergenic extracts (pollens or mites), in polymerized-depot formulation, administered in its different available allergenic extracts mixtures (2 pollens or 2 mites), and in one of the 2 recommended administration schedules (1 Day or Rapid).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 5 and 60 years with allergic rhinitis or rhinoconjunctivitis mediated by IgE, caused by sensitization to more than one allergenic source (pollens or mites) and with or without associated mild / moderate asthma.
- •Patients susceptible to receive treatment with Allergovac Poliplus (SCIT), according to usual clinical practice
- •Patients who have given their signed informed consent.
排除标准
- •Patients who have received or initiated treatment with Allergovac Poliplus previously to study inclusion.
- •Patients who have received previous immunotherapy treatment, both subcutaneous (SCIT) and sublingual (SLIT), with any of the allergenic extracts that they plan to receive, in the 5 years prior to study inclusion.
- •Patients who in the opinion of the investigator may present difficulties that prevent the understanding of what was written in the informed consent form or the completion of self-administered questionnaires / scales or the patient's diary.
- •Patients who are participating in another clinical trial or observational study with any drug.
结局指标
主要结局
Combined Symptoms and Medication Score (CSMS)
时间窗: Basal-12 months
The score ranged from 0 to 6 points and is obtained as follows: Symptoms Score (SS) (from 0 to 3 points) + Medication Score (MS) (from 0 to 3 points). Through these 2 sub-scales the total score of the Combined Symptom and Medication Scale (CSMS) is obtained as follows: CSMS = SS (0-3) + MS (0-3) = 0-6 points The 0 value indicate no symptoms and no medication, and 6 points indicate the worst state of symptoms and the highest medication step
次要结局
- Patient´s Tolerability assessment using a Likert-type scale(6 months-12 months)
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)(Basal-12 months)
- Total number, percentage, severity and gradation of adverse reactions(Basal- 6 months-12 months)
- Patient's perception of the improvement in their global status using a Likert-type scale(12 months)
- Patient's Satisfaction using a Likert scale(12 months)