Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense
关键词
抽象
描述
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with three arms of treatment: placebo and two active (one of the active arms will receive a dose that is 10x the dose of the other arm).
日期
| 最后验证: | 11/30/2010 |
| 首次提交: | 07/12/2007 |
| 提交的预估入学人数: | 07/12/2007 |
| 首次发布: | 07/15/2007 |
| 上次提交的更新: | 12/15/2010 |
| 最近更新发布: | 12/16/2010 |
| 实际学习开始日期: | 08/31/2007 |
| 预计主要完成日期: | 09/30/2009 |
| 预计完成日期: | 09/30/2009 |
状况或疾病
干预/治疗
Biological: Immunotherapy with modified extract of P. pratense pollen
Other: C
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: A: Biological vaccine The first active arm will receive a dose that is 10x less than the dose of the other arm | |
| Experimental: B: biological vaccine The first active arm will receive a dose that is 10x more than the dose of the other arm | |
| Placebo Comparator: C | Other: C Placebo 2 drops daily |
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 |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Positive clinical history of allergy to Phleum pratense - Patients of both gender aged from 12 up to 50 years. - Positive prick test to Phleum pratense allergen extracts - Specific IgE to Phleum pratense - Positive clinical history of allergic rhinoconjunctivitis and/or asthma - Written informed consent. Exclusion Criteria: - Use of immunotherapy during the last four years. - Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria: - Treatment with ß-blockers - Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role - Patients suffering from immune deficiencies - Patients with serious psychiatric / psychological disturbances - In addition, the following was considered as exclusion criteria: - Pregnant or/ in lactation patients - Patients aspirin intolerance |
结果
主要结果指标
1. Symptom scores [1 year]
次要成果指标
1. Nasal provocation test [1 year]
2. Dose-response skin prick-test [1 year]
3. Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ) [1 year]
4. Medication scores [1 year]
5. Visual scales [1 year]
6. "In vitro" immunological tests [1 year]
7. Record of adverse events [1 year]
