EUCTR2006-005911-82-PL进行中（未招募）1 期
A multicenter, randomised, controlled, double-blind study to evaluate efficacy and safety of a perennial sublingual specific immunotherapy with a solution of grass pollen allergen extract in children with clinically relevant grass pollen sensitivity in comparison to a symptomatic standard treatment with add on placebo
Allergopharma Joachim Ganzer KG0 个研究点目标入组 230 人开始时间: 2009年2月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 230
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
- •Age 4 – < 12 years
- •IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without asthma
- •bronchiale (GINA stage I or II), attributable to grass pollen allergens, documented
- •?positive skin prick test weal for grass pollen at least as large as
- •histaminedihydrochloride (1 %) control reaction or > 5 mm in diameter and
- •?positive RAST/CAP > 2 to grass pollens and
- •?proven clinical relevance of grass pollen allergy by positive conjunctival
- •provocation testing with grass pollen allergens
- •For female patients with childbearing potential: Negative pregnancy test and
- •effective contraception
- •For patients with Asthma bronchiale at entry: specialist confirmed diagnosis and
- •asthma classification as GINA grade I or II
- •Written informed consent
- •At the Beginning of the treatment phase:
- •Patients must have demonstrated a symptom score of at least 4 every day during
- •the week following the peak pollen count in the baseline season
- •Rhinitis / Rhinoconjunctivitis symptoms documented in the patient´s diary during
- •the baseline season
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 or other current specific immunotherapy with grass pollen allergens in any
- •formulation
- •Symptoms related to or strong skin test positivity to other seasonal or perennial
- •allergens (skin prick test weal > 5 mm and/or as large as histaminedihydrochloride
- •(1%) control reaction, if clinical relevance cannot be excluded), which are effective
- •in the same period as the relevant grass pollens (June – August)
- •Previous course of hyposensitisation against grass pollen or other allergens that
- •are not known
- •Specific immunotherapy with any other allergens during the course of the study
- •Patients that have undergone an unsuccessful course of specific immunotherapy
- •with any allergen
- •Clinically relevant rhinoconjunctival or respiratory symptoms related to other
- •Peak Flow < 80% of predicted normal (ECCS)
- •Severe bronchial asthma (GINA grade III and IV)
- •Allergy treatment according to severity of symptoms with other than the following
- •medication during the grass pollen season: Levocabastine nasal spray/eye drops,
- •Loratadine tablets, Cetirizine juice / tablets, Salbutamol and short course
- •treatments on prescription with nasal corticosteroids or oral corticosteroids.
- •Febrile infections or inflammation of the respiratory tract at the time of inclusion
- •Severe acute or chronic diseases, severe inflammatory diseases (liver, kidneys,
- •metabolic diseases)
- •Autoimmune diseases, immune-defects including immuno-suppression, immune-
- •complex-induced immunopathies
- •Previous or ongoing use of anti-IGE antibodies, tranquilizers or psychoactive
- •Severe psychiatric and psychological disorders including impairment of cooperation
- •(e.g. alcohol or drug abuse)
- •Treatment with ß-blockers
- •Recurrent seizures
- •Pregnancy and lactation period
- •Concurrent participation in any other clinical trial or participation in any other clinical
- •trial during the previous 30 days
- •Low compliance or inability to understand instructions/study documents
- •Patients being in any relationship of dependence with the sponsor and/or with the
- •investigator
- •Patients, who are institutionalised due to a official or judicial order
- •Mentally disabled minors
- •Contra-indications for application of adrenaline (e.g. severe acute or chronic
- •symptomatic coronary heart disease, severe arterial hypertension)
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