Allergic Rhinoconjunctivitis and Chronic Urticaria
Conditions
Interventions
Trade Name: - Bilaxten (for Spain, Portugal, Poland and Peru)
- Lendin (for Hungary)
- Nixar (for Croatia)
- Bilastina FAES (for Argentina)
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN:
Sponsors
FAES FARMA, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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). Are the trial subjects under 18? yes Number of subjects for this age range: 504 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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). ;Secondary Objective: The assessment of: •safety and tolerability of bilastine in terms of physical examination, vital signs, ECG, blood tests, somnolence/sedation. •quality of life. ;Primary end point(s): Proportion of children without Treatment-Emergent Adverse Events (TEAEs) throughout the course of the study.;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
Argentina, Croatia, Hungary, Peru, Poland, Portugal, Spain
Contacts
Public ContactClinical Monitoring
Nuvisan
Outcome results
None listed