Revaccination With Pollinex® Quattro
关键词
抽象
描述
The increasing prevalence of allergies represents a major problem for the health care system. Approximately 500 million people are suffering worldwide from allergic rhinitis (AR). Allergic rhinitis is a Type 1 hypersensitive disorder, initiated by IgE antibodies. Whereas seasonal allergic rhinitis (SAR) is caused by different allergens found outdoors such as grass, tree and weed pollen, perennial allergic rhinitis (PAR) is caused by allergens that are mainly found indoors such as dust mites, mould or animal hair.
Specific immunotherapy (SIT) presently constitutes the only causal therapy available and is common practice. SIT is indicated in cases of IgE-mediated allergic diseases and includes two forms of treatment options: subcutaneous (SCIT) and sublingual immunotherapy (SLIT). Both therapies aim to train the immune system not react to supposed pathological allergens, but instead to develop tolerance to them.
Even though allergy vaccinations have been applied for a century, the commonly used SCIT requires up to 90 injections over three to five years. Pollinex® Quattro is currently the only ultra-short term medicinal product which requires only four preseasonal injections. The immunological effect associated with Pollinex® Quattro shows an increase of allergen-specific IgG antibodies and a decrease of allergen-specific IgE antibodies as well as a shift from a Th2 to a more Th1 type-immune reaction. Previous studies on the therapeutic efficacy of Pollinex® Quattro have come to a positive conclusion in regards to tolerability and decrease of allergic symptoms. As an ultra-short course SCIT, Pollinex® Quattro might decrease the number of noncompliance and withdrawal for revaccination in patients that have already undergone an intensive immunisation therapy.
In this non-interventional study, patients who were treated with Pollinex® Quattro and patients who decided to use anti-allergic drugs for the treatment of their grass pollen allergy were compared due to their allergic symptoms in the grass pollen season from May to July. For this purpose, the rhinoconjunctivitis and asthmatic symptoms as well as the use of concomitant medication were documented in a dia
日期
| 最后验证: | 09/30/2016 |
| 首次提交: | 10/15/2015 |
| 提交的预估入学人数: | 10/18/2015 |
| 首次发布: | 10/19/2015 |
| 上次提交的更新: | 10/23/2016 |
| 最近更新发布: | 10/24/2016 |
| 实际学习开始日期: | 02/28/2015 |
| 预计主要完成日期: | 09/30/2015 |
| 预计完成日期: | 09/30/2015 |
状况或疾病
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Group 1: Pollinex® Quattro Patients Patients treated with Pollinex® Quattro | |
| Group 2: Control Patients Patients who decided to use only anti-allergic drugs during the grass pollen season |
资格标准
| 有资格学习的年龄 | 12 Years 至 12 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen. A previous specific immunotherapy finished at least five years ago had to be successful. Exclusion Criteria: - Contraindications according to the patient information leaflet |
结果
主要结果指标
1. Assessment of the efficacy of Pollinex® Quattro based on the Combined Symptom and Medication Score (CSMS) (Pfaar et al., 2014). [3 months]
