EUCTR2007-002808-18-DE进行中（未招募）不适用
A double-blind placebo controlled dose-response study for evaluation of safety and efficacy of immunotherapy with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) adsorbed onto aluminium hydroxide in patients with IgE-mediated allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma - ADRET-Trial: Recombinant Phleum - Dose-response Study
ALLERGOPHARMA JOACHIM GANZER KG0 个研究点目标入组 50 人开始时间: 2007年7月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male and female outpatients, 18-50 years
- •- Patients with IgE-mediated, moderate to severe seasonal allergic rhinitis with controlled asthma (FEV1 at least 80% predicted normal according to ECCS (GINA 2006)), attributable to grass pollen allergens
- •- Main symptoms of allergic rhinitis/rhinoconjunctivitis against grass pollen allergens and
- •- Proven clinical relevance of grass pollen allergy by positive conjunctival provocation test result using natural grass pollen extract
- •- Positive prick test reaction to natural grass pollen allergen demonstrated by allergen weal at least as large as histamine control reaction (histaminedihydrochloride 1,7mg/ml histamine, 0,1%) and > 5 mm diameter and a negative control test (saline solution). A positive histamine control reaction is demonstrated by weal diameter >=3mm, a negative control test is demonstrated by weal diameter <3mm) and
- •- Positive EAST (Allergopharma Joachim Ganzer KG) to grass pollen >= 2 measured by Central Lab
- •- For female patients: effective contraception and negative pregnancy test result
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Previous course of hyposensitation against grass pollen or other allergens that are not known
- •- Patients that have undergone an unsuccessful course of specific immunotherapy with any allergen
- •- Symptoms during the months Nov-April and skin test positivity (weal diameter = histamine 0,1% or >= 5 mm) to birch alder, hazel, Dermatophagoides pteronyssinus, Dermatophagoides farinae, dog, cat, Aspergillus, Penicillium. Alternaria and Cladosporium if clinical relevance of this sensitisation cannot be excluded by provocation test.
- •- Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons that have not been clearly identified
- •- FEV1 < 80 % of predicted normal (ECCS) or partly controlled/uncontrolled bronchial asthma according to GINA 2006
- •- Patients that are not adequately treated with a short acting ß2-Mimetic and 500 µg BDP or 400µg budesonide (equiv.).
- •- Vasomotor, drug-induced or other kinds of non allergic rhinoconjunctivitis
- •- Febrile infections or inflammation of the respiratory tract at time of inclusion
- •- Irreversible secondary alterations of the reactive organ
- •- Severe acute or chronic diseases, severe inflammatory diseases
- •- Other severe generalised diseases (liver, kidneys, metabolic diseases, heart, vascular diseases)
- •-contra-indication for adrenaline (for example acut or chronic symptomatic coronary heart disease, severe hypertension)
- •- Autoimmune diseases, immune-defects including immuno-suppression, immune-complex-induced immunopathies
- •- Multiple sclerosis, active tuberculosis
- •-complete or ongoing treatment with transquillizer or psychoactive drugs
- •- Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
- •- Treatment that could interfere with safety and/or efficacy of the study drug (e.g. treatment with beta-Blockers (locally and systemic), systemic glucocorticoids, leucotrien-antagonists, anti-IgE etc.) during the course of the study
- •- Pregnancy and lactation period
- •- Female patients seeking to become pregnant
- •- Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days
- •- Patients being in any relationship of dependence with the Sponsor and/or with the Investigator.
- •- Low compliance or inability to understand instructions/study documents
研究者
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