E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Allergic Rhinoconjunctivitis and Chronic Urticaria |
alergijski rinokonjiktivitis i kronična urtikarija |
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E.1.1.1 | Medical condition in easily understood language |
Allergic Rhinoconjunctivitis and Chronic Urticaria |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The study objectives will be to evaluate the safety and tolerability of 10 mg once daily bilastine in children from 2 to 11 years of age with either allergic rhinoconjunctivitis or chronic urticaria. The primary objective will be the evaluation of the safety (TEAEs, Treatment Emergent Adverse Events).
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E.2.2 | Secondary objectives of the trial |
The assessment of: •safety and tolerability of bilastine in terms of physical examination, vital signs, ECG, blood tests, somnolence/sedation. •quality of life.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(1) Boys and girls between 2 and 11 years old, inclusive, at screening. (2) Documented history of allergic rhinoconjunctivitis (AR) or chronic urticaria (CU) with clinical symptoms at study entry. (3) For AR patients, a positive skin prick test/RAST for at least one allergen. (4) A 12 lead ECG obtained at screening within acceptable limits, moreover in absence of any drug effect or disease, QTc interval values (msec) after Fridericia’s correction must be normal (not prolonged). The values considered to be normal are lower than 440 msec. (5) Children who have written consent from their parent(s)/guardian to participate in the study. Children should be informed according to their understanding (assent form will be obtained whenever possible). |
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E.4 | Principal exclusion criteria |
(1) Non-allergic rhinitis or acute urticaria. (2) Intake of particular medications with antiallergenic activities or sedative properties. (3) Known allergy/hypersensitivity to the study drug (bilastine) or its inactive ingredients. (4) Patients who are taking or have taken any of the following medications prior to randomisation in the study and have not complied with the specified washout period of 7 days unless otherwise noted: • Oral corticosteroids. • Antihistamines: Loratadine/ desloratadine (10 days) other systemic antihistamines (3 days). • Anti-leukotrienes. • Delayed-release corticosteroids (3 months). • Ketotifen (2 weeks). • Macrolides antibiotics and imidazolic antifungals (systemic). • Anticholinergics. • Investigational medication or antibodies. • Regular schedule immunotherapy can be maintained throughout the study but will be disallowed from 24h prior to 24h after first study dosing. (5) Clinically relevant abnormal laboratory values indicative of physical illness (including clinically significant ECG abnormalities as judged by the investigator; e.g. Wolff-Parkinson-White syndrome or long QT syndrome), or patient whose health could be harmed by their participation in the study at investigator criteria. (6) Hypersensitivity to H1 antihistamines or benzimidazoles. (7) Any clinical conditions or relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, haematological, endocrine or neurological diseases that in the opinion of the investigator would make the subject unsuitable for the study or interfere with the aim of the study. (8) Children or parent(s) unable to comply with the study requirements (attendance to visits), unable to take the study treatment, or children that should have to travel to another geographic area during the course of the study. (9) Girl who is pregnant or lactating. (10) Children who have a recent history (within previous 12 months) of drug addiction or alcohol abuse. (11) Participation in another clinical study within 30 days prior to the first study drug intake. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of children without Treatment-Emergent Adverse Events (TEAEs) throughout the course of the study. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Proportion of children with related TEAEs throughout the course of the study. • Incidence of TEAEs by System and Organ Class (SOC) and Preferred Term (PT) using MedDRA terminology. • Laboratory blood tests (haematology and biochemistry) performed at baseline and end of treatment. • Assessment of cardiac safety by ECG recording at each visit. • Assessment of somnolence or sedation, by means of the Pediatric Sleep Questionnaire (PSQ) at each visit. • Assessment of the child’s Quality of Life (QoL) by means of the Paediatric Rhinitis Quality of Life Questionnaire (PRQLQ), and the Children’s Dermatology Life Quality Index (CDLQI) to be administered to children according to the relevant disease. QoL scales will be administered at baseline and at the end of treatment. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |