EUCTR2013-000492-32-FI进行中（未招募）不适用
T cell and interferon expression in tonsils after sublingualimmunotherapy and/or nasal live attenuated influenza vaccine - Tons2
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •-elective tonsillectomy with or without adenotomy according to clinicl indication
- •-age >4 and <30 years (controls without age limits)
- •-written informed consent from the study subject or his/her guardian
- •-FluMist/Fluenz® will be used for ages >4 and <30 years, i.e. off-label use of ages >18 and <30 years
- •-Grazax® and Staloral® -birch will be used for ages = 5, according to selling permit
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-systemic anti-inflammatory medication within prior 4 weeks -systemic diseases affecting the immune system e.g. autoimmune
- •diseases, immune complex diseases or immune deficiency diseases other than allergy, asthma or atopic dermatitis
- •-malignancy, depression, psychiatric illness or medication; planned vaccination during the study period
- •-forced expiratory volume in 1 second (FEV1) is under 80% of normal value or asthma is in a bad balance for those patients who would participate in the immunotherapy
- •-sublingual grass pollen will not be given for children under the age of 5 -additional exclusion criteria for Grazax® include hypersensitivity to any of the excipients (gelatin [fish source], mannitol, sodium hydroxide), inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis, patients with uncontrolled or severe asthma (in adults: FEV1 < 70% of predicted value after adequate pharmacologic treatment, in children: FEV1 < 80% of predicted value after adequate pharmacologic treatment)
- •-addition exclusion criteria for FluMist/Fluenz® include hypersensitivity to the active substances, to any of the excipients and children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild- type influenza infection.
- •-Additional exclusion criteria for Staloral® -birch include hypersensitivity to any of the expicients (sodium chloride, glycerol, mannitol, purified water), serious immunodefiency, malignant diseases, unstable asthma, auto-immune diseases, oral inflammation or bleeding, or ongoing treatment with beta-blockers.
研究者
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