EUCTR2018-003940-21-ES进行中（未招募）1 期
A pilot, multicentre, single-blind, randomized, placebo-controlled, parallel-group clinical trial, to assess the safety of Bilastine treatment regarding psychomotor performance using a virtual reality tool (AULA®), in 9 to 11 years old children with allergic rhinitis and/or urticaria. - BiViClasS Project (Bilastine, Virtual Classroom Safety)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
入选标准
- •1) 9 to 11 years old children between 25 and 50 kg of weight, both inclusive, at the time of inclusion in the study.
- •2) Patients must have a documented clinical history (of at least 6 months) of allergic rhinoconjunctivitis (AR) and/or urticaria, and they must present mild to moderate clinical symptoms at the time of their inclusion in the study.
- •3) Patients with allergic rhinoconjunctivitis must have documented in their clinical history a positive skin reaction/RAST test within the year prior to their inclusion in the study: a positive prick-test (wheal diameter of at least 3 mm) or specific IgE > 0,70 KUA/L, at least against one allergen.
- •4) Patients must have a clinical history of positive response to treatment with antihistamines.
- •5) Patients should not have any sign in their clinical history of significant abnormalities in previous analytical determinations (such as blood count, biochemistry). If there were anomalies, it should be verified and documented with the performance of the corresponding analytical determination that the patient has normalised his/her situation (and presents values within the range of normality) before his/her inclusion in the study.
- •6) Patients must have a 12-lead electrocardiogram (ECG) documented within the limits of normality. If they did not have it, the patient should undergo a 12-lead ECG that meets criteria of clinical normality before being included in the study.
- •7) A written consent of the parents/legal guardians of the children must be obtained so that they can participate in the study. Children must be informed about the study according to their abilities.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •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
- •1) Rhinitis of non-allergic origin.
- •2) Intake of medications with sedative properties.
- •3) Known allergy and/or hypersensitivity to antihistamines H1 (specifically to the study medications -bilastine, hydroxyzine- or its inactive ingredients) or to benzimidazoles.
- •4) Patients who are taking or have taken any of the following medications before their inclusion in the study and who have not complied with the specific 7 day-wash-out period, unless otherwise stated:
- •Oral corticosteroids
- •Topic, nasal or ocular antihistamines (7 days)
- •Systemic antihistamines: loratadine / desloratadine (7 to 10 days), other systemic antihistamines (3 days)
- •Antileukotrienes
- •Ketotifen (2 weeks)
- •Delayed-action corticosteroids (3 months)
- •Macrolide antibiotics and imidazole fungicides (systemic)
- •Anticholinergics
- •Medication under research or antibodies
- •Scheduled immunotherapy will be maintained on a regular basis during the study, but it will not be allowed from 48 hours prior to 48 hours after the first dose of the study medication.
- •5) Attention Deficit Hyperactivity Disorder (ADHD), pathologies of the spectrum of autism or sleep disorders, diagnosed in the 6 months prior to the inclusion of the patient in the study.
- •6) Any relevant clinical condition (or history) of renal, hepatic, gastrointestinal, cardiovascular, respiratory, hematological, endocrine or neurological disease, which prevents the child from being able to participate in the study or that may interfere with the objectives thereof, according to researcher´s opinion.
- •7) Abnormalities in the laboratory parameters (including alterations in the ECG) that are clinically relevant, or that indicate disease, at the investigator´s discretion.
- •8) Children or parents unable to comply with the requirements of the study (attendance to the visits), unable to adequately take the study treatment, or children who should travel to another geographical area during the study.
- •9) Participation in another clinical trial within 30 days prior to the intake of the first dose of the study medication.
- •10) Girls with menarche.
- •11) Any other characteristic of the participant or of his/her environment that, in the investigator´s opinion, makes him/her inappropriate to participate in the study (for example, the detection or suspicion of drug or other substances abuse; if participation in the study could harm the health of the participant, etc.)
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