Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis
Intervention: Loratadine (Drug); Betamethasone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
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
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: September 2003
Last updated: April 20, 2015
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