EUCTR2020-004372-17-PL进行中（未招募）1 期
Efficacy and safety of the SQ tree sublingual immunotherapy tablet in children and adolescents (5 through 17 years of age) with moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch and trees belonging to the birch homologous group.P/0030/2018; P/0434/2020
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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
- •Subjects are eligible to be included in the trial only if all the following criteria apply:
- •Male or female of any race/ethnicity aged =4 to <18 years on the day informed consent is obtained from the parent/caregiver; the subject must be =5 to <18 years old at the randomisation visit
- •A documented, physician diagnosed, clinically relevant history of moderate to severe AR/C induced by birch pollen (with or without asthma) despite having received treatment with symptom-relieving medication during at least 1 previous tree pollen season for ages 4 through 6 years at screening or at least 2 previous tree pollen seasons for ages 7 through 17 years at screening
- •Positive skin prick test (SPT) to Betula verrucosa at screening
- •Positive specific IgE to Bet v at screening
- •Presence of 1 or more of the following Allergic Rhinitis Impact on Asthma (ARIA) quality of life items due to AR/C during the previous BPS:
- •a.Sleep disturbance
- •b.Impairment of daily activities, leisure and/or sport
- •c.Impairment of school or work
- •d.Troublesome symptoms
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1000
- •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
- •Subjects are excluded from the trial if any of the following criteria apply:
- •A clinically relevant history of symptomatic seasonal AR/C caused by an allergen source, other than tree pollen from the birch homologous group, with a season overlapping the TPS
- •A clinically relevant history of symptomatic perennial AR/C caused by an allergen source such as animal hair and dander to which the subject is exposed during the TPS
- •Any clinical deterioration of asthma (i.e. asthma exacerbation) that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to randomisation
- •Reduced lung function at randomisation defined as forced expiratory volume in 1 second (FEV1) <70% of predicted value. For subjects with asthma, this is assessed on subject’s usual asthma medication following at least a 6-hour wash-out of SABA. This criterion does not need to be fulfilled if the subject is <7 years old, cannot perform reproducible FEV1 manoeuvres despite coaching and is not considered as having a diagnosis of asthma
- •Ongoing treatment with any allergy immunotherapy product
- •Severe chronic oral inflammation
- •A diagnosis of eosinophilic oesophagitis
- •A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern
- •Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
研究者
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