Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Persistent Allergic Rhinitis Treatment

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of Moderate - Severe Persistent Allergic Rhinitis.

Detailed Description
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double-blind, non-inferiority, prospective, parallel group trial. Experiment duration: 07 days. 02 visits (days 0 and 7). Efficacy will be evaluated for persistent allergic rhinitis based on nasal symptoms score Adverse events evaluation.

Official Title
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A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Moderate - Severe Persistent Allergic Rhinitis

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Dexchlorpheniramine + Betamethasone
* Drug: Desloratadine + Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent of the patient or legal guardian; Clinical diagnosis of moderate - severe persistent allergic rhinitis according to the classification of ARIA (Allergic Rhinitis and Its Impact on Asthma); Children aged between 2 and 11 years and 11 months (up to 30 kg); Presence of nasal symptoms score greater than or equal to 5 (scale 0 to 12)in the last week; Evidence of sensitization to aeroallergens in examination (immediate skin tests or serum specific IgE) in the 12 months prior to inclusion. Exclusion Criteria: Participation in clinical trial in 30 days prior to study entry; Patients receiving immunotherapy; Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ; Patients with any clinically significant disease other than allergic rhinitis, including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders; Patients on treatment with monoamine oxidase inhibitors (MAOIs); Patients who were in use of oral antihistamines or decongestants in the past 15 days; Patients who were treated with systemic corticosteroids in the last month; Patients who have uncontrolled asthma, chronic sinusitis, drug related rhinitis and nasal anatomic abnormalities.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desloratadine + Prednisolone<br>Desloratadine(0.5 mg/ml) Associated With Prednisolone (4 mg/ml) Oral Solution once a day - bottle 1 + placebo 2 times a day - bottles 2 and 3. | Drug: Desloratadine + Prednisolone<br>* Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day<br>|
| Active Comparator: Dexchlorpheniramine + Betamethasone<br>Dexchlorpheniramine (0.4 mg/ml) + Betamethasone (0.05 mg/ml) three times a day - bottles 1, 2 and 3. | Drug: Dexchlorpheniramine + Betamethasone<br>* Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score | The mean variability of nasal symptoms score observed between visit 1 and visit 2 will be used as the primary endpoint of clinical efficacy. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by the adverse events occurrences | Adverse events will be collected and followed in order to evaluate safety and tolerability | 7 days |