Back to resultsEfficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)
Primary Purpose
Rhinitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Loratadine
Betamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
loratadine/betamethasone oral solution
Arm Description
loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00963573
First Posted
August 20, 2009
Last Updated
April 20, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00963573
Brief Title
Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
loratadine/betamethasone oral solution
Arm Type
Experimental
Arm Description
loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
Intervention Type
Drug
Intervention Name(s)
Loratadine
Other Intervention Name(s)
SCH 029851
Intervention Description
loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
Intervention Type
Drug
Intervention Name(s)
Betamethasone
Other Intervention Name(s)
SCH 029851
Intervention Description
loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
23282980
Citation
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.
Results Reference
result
Learn more about this trial
Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)
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