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

NCT ID: NCT00963573

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2006-11-30

Brief Summary

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.

Conditions

Rhinitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

loratadine/betamethasone oral solution

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

Group Type: EXPERIMENTAL

Loratadine

Intervention Type: DRUG

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

Betamethasone

Intervention Type: DRUG

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

Interventions

Loratadine

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

Intervention Type: DRUG

Betamethasone

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

Intervention Type: DRUG

Other Intervention Names

SCH 029851; SCH 029851

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Mendoza de Morales T, Sanchez 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.

Reference Type: RESULT

PMID: 23282980 (View on PubMed)

Other Identifiers

P03428

Identifier Type: -

Identifier Source: org_study_id