Allergic rhinoconjunctivitis (both seasonal allergic rhinitis -SAR- and perennial allergic rhinitis -PAR-) and/or urticaria.
Conditions
Interventions
Trade Name: BILAXTEN
Pharmaceutical Form: Oral solution
INN or Proposed INN: BILASTINE
CAS Number: 202189-78-4
Current Sponsor code: F-9
Sponsors
FAES FARMA, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Assessment of bilastine safety based on psychomotor performance and safety profile. - Psychomotor performance assessment with AULA®: Change in mean reaction time to stimuli by correctly pressing the button throughout the AULA® test and the Task X-No; Change in mean reaction time in the comissions throughout the AULA® test and in each of the tasks; Change in the nr. of total hits, hits by pressing and not pressing the button, throughout the AULA® test and in each of the tasks; Change in the nr. of total errors, in the nr. of commissions and of omissions throughout the AULA® test and in each of the tasks; Change in the motor activity throughout the AULA® test and in each of the tasks. - Safety profile assessment: -Incidence of AEs throughout the entire study; -Change in the Paediatric Sleep Questionnaire score at Days -7, 0 and 4, to assess somnolence;-Clinically relevant variation on Days -7, 0 and 4 in vital signs/other parameters of physical examination. ;Timepoint(s) of evaluation of this end point: The change or variation will be calculated as the difference between the mean reaction time (to the stimuli correctly answered by pressing the button in Task X) obtained in the initial assessment (Day 0) versus the final assessment (Day 4) of AULA® test, and it will be calculated for each participant and for each treatment group.; Main Objective: The aim of the study will be to evaluate the safety of a daily dose of bilastine 10 mg in 9 to 11 years old children with allergic rhinitis and/or urticaria versus placebo, in terms of psychomotor performance, by using a virtual reality tool that reproduced the school environment called AULA®. For this purpose, we will evaluate the mean change in the reaction time (in milliseconds) to the stimuli by correctly pressing the button on Task X of AULA® test. The mean change will be calculated as the difference between | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Psychomotor performance assessment with AULA®: variables to consider: • Change in mean reaction time* (ms) to stimuli by correctly pressing the button throughout the AULA® test (Task X-No and Task-X) and the Task X-No. • Change in mean reaction time (ms) in the comissions (errors by pressing the button) throughout the AULA® test and in each of the tasks. • Change in the number of total hits, hits by correctly pressing and not pressing the button. • Change in the number of total errors (omissions + commissions), in the number of commissions (error by pressing the button: impulsivity) and of omissions (error by not pressing the button: inattention). • Change in the motor activity throughout the AULA® test and in each of the tasks. All the indicated variables will be analysed taking into account these factors: - Type of Task (Task X-No or Task X) - Type of stimuli (visual or auditory) - Distractors (presence or abscense) - Task Sets (first or second set) Safety profile assessment: • Incidence of Adverse Events (AEs) • Change in the Paediatric Sleep Questionnaire (PSQ) • Clinically relevant variation in vital signs or other parameters of physical examination, including clinical assessment. ; Timepoint(s) of evaluation of this end point: Psychomotor performance assessment will be evaluated during the final assessment (Day 4) and it will be calculated for each participant and for each treatment group. Safety profile assessment will be evaluated along the study until the telephone call (safety follow up), one week after the end of the study treatment. | — |
Countries
Spain
Contacts
Public ContactClinical Research Director
FAES FARMA, S.A.
Outcome results
None listed