Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU)

NCT01081574 | Completed Phase 1

• 2 other identifiers: BILA 3009/PED2009-012013-22
• Study Type: interventional
• Target: 36
• Locations: 3 countries
• Sites: 7

Brief Summary

The conduct of this clinical trial is aimed at determining the most suitable dose regimen for children in different age groups, and secondarily to assess the safety and tolerability of bilastine in this paediatric population subset.

Conditions

Allergic Rhinoconjunctivitis; Chronic Urticaria

Keywords

Allergic Rhinitis; Seasonal Allergic Rhinitis; Perennial Allergic Rhinitis; Urticaria; Chronic Idiopathic Urticaria; Allergy; Sneezing; Nasal Itching; Rhinorrhea; Nasal Congestion; Wheals; Hives; Skin itching; Flare; Erythema

Outcome Measures

Primary Outcomes (1)

• The primary objective is to assess the pharmacokinetics of bilastine in children (aged 2 to <12 years) with allergic rhinoconjunctivitis (seasonal allergic rhinitis and/or perennial allergic rhinitis [SAR/PAR]) or chronic urticaria (CU)

  Determination of plasma concentrations versus time (between 1 and 6 samples per subject at various time intervals after dosing according to an optimised sampling protocol) in order to perform a population pharmacokinetic analysis. For Group A, samples of venous blood will be just prior to dose administration, and at 0.25, 0.5, 0.8, 1.0, 1.2, 1.5, 3.0, 4.0, 6.0, 8.0, 10.0, 12.0, and 24.0 hours after dose administration. For Group B samples of venous blood will be just prior to dose administration, and at 0.25, 0.5, 1.0, 1.5, 3.0, 6.0, 8.0, 10.0, and 12.0 hours after dose administration.

  1 day (visit 3, Day 7)

Secondary Outcomes (1)

• The secondary objectives are to describe the safety and tolerability of a repeated administration of bilastine in the aforementioned paediatric subset with allergic rhinoconjunctivitis (SAR/PAR) or chronic urticaria (CU).

  5 weeks

Study Arms (1)

10 mg Bilastine once daily for 7 days

EXPERIMENTAL

10 mg Bilastine dispersible oral tablet

Drug: Bilastine

Interventions

Bilastine DRUG

10 mg/qd/ 7 days.Oral dispersible tablets

Also known as: Bilaxten

10 mg Bilastine once daily for 7 days

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Either sex aged from ≥ 2 to \< 12 years of age. Female subjects must not be of child bearing potential.
• Height and weight within a majority range (e.g., 25th through 75th percentile) of the subject's age and sex as provided in national tables.
• Excepting AR or CU, judged to be in general good health based on medical history, physical examination and clinical laboratory tests, with a QTc duration on the ECG recorded at screening within the normal range (≤ 440 msec).
• Written informed consent signed by the legal representative of the minor (his/her parent(s) or a person legally appointed if different from parent(s)) and, where applicable, assent signed by the child, according to local regulations.

You may not qualify if:

• Female subjects of childbearing potential. If menarche occurs after study enrolment and during the dosing period, the subject should be discontinued from the treatment and followed up for safety as per protocol. Occurrence of menarche in the course of the study should always be documented.
• Intake of another investigational medication in another clinical study within 30 days prior to the first study drug intake.
• Clinically significant ECG abnormalities as judged by the investigator (e.g., Wolff-Parkinson-White \[WPW\] syndrome, long QT syndrome).
• Known allergy/hypersensitivity to the study drug or its inactive ingredients.
• Any clinical conditions or circumstances that in the opinion of the investigator would make the subject unsuitable for the study (e.g., hepatic impairment, renal impairment, mental impairment, cardiac disease).
• Subjects with known positive Hepatitis B surface antigen (Hbs Ag), or Hepatitis C antibody or who are known to be human immunodeficiency virus (HIV) positive. No testing will be required for this study.
• Oral corticosteroids.
• Oral antihistamines: loratadine, desloratadine, and fexofenadine.
• Anti-leukotrienes
• Amoxicillin, benzylpenicillin, and macrolide antibiotics and imidazolic antifungals (systemic)
• Omeprazol
• Aspirin, ibuprofen
• Carbamazepine
• St. John's Wort (15 days)
• Hypersensitivity to H1 antihistamines or benzimidazoles.

Sponsors & Collaborators

• Faes Farma, S.A.: lead

Study Sites (7)

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Princess Margaret Hospital for Children

Subiaco, Western Australia, 6840, Australia

Location

Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie

Berlin, 13353, Germany

Location

Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt

Franfurt, 60590, Germany

Location

Universitäts-Hautklinik

Kiel, 24105, Germany

Location

Karolinska University Hospital. Astrid Lindgren's Hospital

Stockholm, 17176, Sweden

Location

Children's Hospital at Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

Related Publications (5)

• Jauregizar N, de la Fuente L, Lucero ML, Sologuren A, Leal N, Rodriguez M. Pharmacokinetic-pharmacodynamic modelling of the antihistaminic (H1) effect of bilastine. Clin Pharmacokinet. 2009;48(8):543-54. doi: 10.2165/11317180-000000000-00000.

  PMID: 19705924 BACKGROUND

• Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, Antepara I, Jauregui I, Valiente R; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy. 2010 Apr;65(4):516-28. doi: 10.1111/j.1398-9995.2009.02217.x. Epub 2009 Oct 23.

  PMID: 19860762 BACKGROUND

• Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010 May;59(5):391-8. doi: 10.1007/s00011-009-0117-4. Epub 2009 Nov 27.

  PMID: 19943178 BACKGROUND

• Kuna P, Bachert C, Nowacki Z, van Cauwenberge P, Agache I, Fouquert L, Roger A, Sologuren A, Valiente R; Bilastine International Working Group. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study. Clin Exp Allergy. 2009 Sep;39(9):1338-47. doi: 10.1111/j.1365-2222.2009.03257.x. Epub 2009 May 4.

  PMID: 19438584 BACKGROUND

• Bachert C, Kuna P, Sanquer F, Ivan P, Dimitrov V, Gorina MM, van de Heyning P, Loureiro A; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy. 2009 Jan;64(1):158-65. doi: 10.1111/j.1398-9995.2008.01813.x.

  PMID: 19132976 BACKGROUND

MeSH Terms

Conditions

Chronic Urticaria; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial; Urticaria; Hypersensitivity; Sneezing; Rhinorrhea; Nasal Obstruction; Pruritus; Erythema

Interventions

bilastine

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Skin Manifestations

Study Officials

• Ulrich Wahn, Prof. Dr.

  International Coordinating Investigator. Charité - Universitätsmedizin Berlin (Germany)

  PRINCIPAL INVESTIGATOR

• Regina Föster-Holst, Prof. Dr.

  Universitäts-Hautklinik Kiel (Germany)

  PRINCIPAL INVESTIGATOR

• Belén Sádaba, Dr.

  Clínica Universitaria de Navarra (Spain)

  PRINCIPAL INVESTIGATOR

• Gunilla Hedlin, Prof. Dr.

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Stefan Zielen, Prof. Dr.

  J.W. Goethe-Universität Frankfurt (Germany)

  PRINCIPAL INVESTIGATOR

• Lennart Nordvall, Prof. Dr

  Children's Hospital at Uppsala University Hospital (Sweden)

  PRINCIPAL INVESTIGATOR

• Peter Le Souef, Prof. Dr.

  Princess Margaret Hospital for Children (Australia)

  PRINCIPAL INVESTIGATOR

• Noel E Cranswick, Prof. Dr.

  Royal Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: March 5, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 26, 2012

Record last verified: 2012-09

Locations

AU (2); DE (3); SE (2)