Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)

Overview

This study attempts to document the therapeutic value of combining loratadine antihistamine action (no sedative) with anti-inflammatory effects of betamethasone at low doses, which may facilitate treatment adherence by patients whereas providing an effective and rapid perennial allergic rhinitis (PAR) symptoms relief.

Full Title of Study: “Efficacy and Safety of Loratadine-Betamethasone Oral Solution (1 mg/0.05 mg/1 mL) for Initial Treatment of Severe Perennial Allergic Rhinitis in School Age Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2006

Interventions

  • Drug: Loratadine
    • loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
  • Drug: Betamethasone
    • loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg

Arms, Groups and Cohorts

  • Experimental: loratadine/betamethasone oral solution
    • loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg

Clinical Trial Outcome Measures

Primary Measures

  • To evaluate efficacy and safety of loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg, respectively, as an initial treatment for severe perennial allergic rhinitis in school age children
    • Time Frame: Day 6 (Final visit)

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of perennial allergic rhinitis.
  • Age >= 6 years old and <= 12 years old.
  • Patients in good general conditions, without any other relevant clinical condition except for perennial allergic rhinitis.
  • Symptoms total score at admission >= 8 (out of 15 possible). Individual symptoms (score 0 to 3 points) were: Sneezing or nasal pruritus, eye reddening or pruritus, nasal congestion, wet nose or with secretion (sniffing), secretion sensation at pharynx (post-nasal dripping).
  • Number of symptoms: At least three.

Exclusion Criteria

  • Age < 6 years old or > 12 years old.
  • Co-existence of acute sinusitis or some chronic condition different from asthma or atopic dermatitis.
  • Presence of systemic fungal infections.
  • Conscience or behavioral disturbances.
  • Current oral or parenteral steroid treatment.
  • Concomitant use of Phenobarbital, rifampicin, diphenylhydantoin or ephedrine.
  • Known hypersensitivity to any of the study pharmacological combination components.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor

Citations Reporting on Results

Mendoza de Morales T, Sánchez F. Clinical efficacy and safety of a combined loratadine-betamethasone oral solution in the treatment of severe pediatric perennial allergic rhinitis. World Allergy Organ J. 2009 Apr;2(4):49-53. doi: 10.1097/WOX.0b013e31819f2105.

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