NCT00501527已完成2 期
Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense in Patients Suffering From Allergic Rhinoconjunctivitis and/or Asthma
Laboratorios Leti, S.L.2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Symptom scores
研究概览
简要总结
The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Phleum pratense in the rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass pollen.
详细描述
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).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Symptom scores
时间窗: 1 year
次要结局
- Nasal provocation test(1 year)
- Dose-response skin prick-test(1 year)
- Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ)(1 year)
- Medication scores(1 year)
- Visual scales(1 year)
- "In vitro" immunological tests(1 year)
- Record of adverse events(1 year)
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Subcutaneous-Sublingual Immunotherapy With Depigmented and Polymerized Dermatophagoides Pteronyssinus Allergen ExtractAllergic AsthmaNCT00622362Laboratorios Leti, S.L.3
Unknown
3 期
Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust MitesAllergic RhinitisNCT01013116Roxall Medizin120
已完成
不适用
Clinical Study for the Efficacy Evaluation of a Food SupplementSpot PigmentedWrinkleNCT06453837Mibelle Group Biochemistry110
终止
2 期
Safety and Efficacy Study of MAGE-A3 + AS-15 in Patients With Muscle-invasive Bladder Cancer After CystectomyUrinary Bladder NeoplasmsNCT01435356European Association of Urology Research Foundation83
已完成
4 期
Immunogenicity of Influenza Vaccines in HIV-infected Persons in ThailandInfluenzaNCT01538940Centers for Disease Control and Prevention415