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

NCT00963573 | Completed Phase 4

• 1 other identifier: P03428
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

loratadine/betamethasone oral solution

EXPERIMENTAL

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

Drug: Loratadine; Drug: Betamethasone

Interventions

Loratadine DRUG

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

Also known as: SCH 029851

loratadine/betamethasone oral solution

Betamethasone DRUG

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

Also known as: SCH 029851

loratadine/betamethasone oral solution

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 23282980 RESULT

MeSH Terms

Conditions

Rhinitis

Interventions

Loratadine; Betamethasone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 21, 2009
• Study Start: September 1, 2003
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: April 21, 2015

Record last verified: 2015-04