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

Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963573
• Other study ID #: P03428
• Status: Completed
• Phase: Phase 4
• First received: August 20, 2009
• Last updated: April 20, 2015
• Start date: September 2003
• Est. completion date: November 2006

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Instituto Nacional de Higiene "Rafael Rangel"
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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.0b013e31819f2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Day 6 (Final visit)	Yes