EUCTR2006-005911-82-DE进行中（未招募）不适用
A multicenter, placebo-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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 by
- •?positive skin prick test weal for grass pollen at least as large as histaminedihydrochloride (1 %) control reaction or > 5 mm in diameter and
- •?positive EAST > class 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 (patients with less symptoms in the baseline season 2008 can repeat the baseline season in 2009)
- •Rhinitis / Rhinoconjunctivitis symptoms documented in the patients’ diary during the baseline season
- •For the treatment free follow-up investigation:
- •Male and female outpatients, previously participating in and completed treatment phase of the clinical trial AL0506st
- •For female patients with childbearing potential: Negative pregnancy test and effective contraception
- •Written informed re-consent for follow-up investigation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 230
- •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 reasons
- •Peak Flow < 80% of predicted normal
- •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 medicine
- •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)
- •For the treatment free follow-up investigation:
- •Specific immunotherapy with grass pollens or any other allergens after the last dose of study drug.
- •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.
- •Previous or ongoing use of anti-IgE antibodies, tranquilizers or psychoactive medicine
- •Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)
- •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
研究者
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