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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: August 20, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted

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.

Condition Intervention Phase
Drug: Loratadine
Drug: Betamethasone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Schering-Plough:

Primary Outcome 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) ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: September 2003
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Loratadine
loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
Other Name: SCH 029851
Drug: Betamethasone
loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
Other Name: SCH 029851


Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00963573     History of Changes
Other Study ID Numbers: P03428
Study First Received: August 20, 2009
Last Updated: August 20, 2009
Health Authority: Venezuela: Instituto Nacional de Higiene "Rafael Rangel"

Additional relevant MeSH terms:
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on April 17, 2014