EUCTR2020-000446-34-DE进行中（未招募）1 期
A 28-day, single-armed, open-label trial to evaluate safety of the house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet in adolescent subjects (12-17 years of age) with HDM allergic rhinitis/rhinoconjunctivitis (AR/C) with or without asthma
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
- 250
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
- •Written informed consent obtained from subjects’ legal representatives before any trial related procedures are performed
- •Male or female subjects aged =12 to =17 years on the screening day (visit 1) and at the FU-TC.
- •A clinical history of moderate to severe allergic rhinitis/rhinoconjunctivitis (AR/C) when exposed to HDM (diagnosed by a physician) of 1-year duration or more (with or without asthma) and with allergic rhinitis (AR) symptoms despite having received allergy pharmacotherapy during the previous year prior to screening visit (visit 1)
- •Positive skin prick test (SPT) to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae at screening (wheal size of =3 mm)
- •Lung function measured by Forced expiratory volume in 1 second (FEV1) = 70% of predicted value or according to local requirements while on subject's usual asthma medication
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 250
- •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
- •A subject who has previously been included in studies with the HDM SLIT-tablet, or otherwise being treated with the marketed HDM SLIT-tablet (e.g. ACARIZAX, ODACTRA)
- •Any SLIT or SCIT (Subcutaneous allergy immunotherapy) treatment with D. pteronyssinus or D. farinae reaching the maintenance dose within the last 5 years. In addition, any SLIT or SCIT treatment with D. pteronyssinus or D. farinae within the previous 12 months prior to visit 1
- •Ongoing treatment with any allergy immunotherapy product at screening
- •Severe chronic oral inflammation
- •A diagnosis or history of eosinophilic oesophagitis
- •Any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to first tablet administration (visit 2)
- •Female with positive urine pregnancy test, breastfeeding, pregnant or planning to become pregnant within the projected duration of the trial
- •Sexually active female of childbearing potential without medically accepted contraceptive method
研究者
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