Comparison of Desloratadine Associated With Prednisolone (Tablet)Versus Dexchlorpheniramine Associated With Betamethasone (Tablet) for Adult 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 in Adults.

Official Title
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A Double-blind,Double Dummy, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Adults With Moderate - Severe Persistent Allergic Rhinitis

Conditions
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Allergic Rhinitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Consent of the patient; Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma); Adults aged ≥ 18 years old; Evidence of sensitization to aeroallergens in examination (immediate skin tests or serum specific IgE) in the 12 months prior to inclusion. Exclusion Criteria: Decongestants dependent patients or patients receiving allergen specific immunotherapy; 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 on treatment with monoamine oxidase inhibitors (MAOIs); Patients with history of hypersensitivity to any of the formula compounds; Patients with any clinically significant disease that in the investigator opinion can not participate in the study Patients who have uncontrolled asthma, chronic sinusitis, drug related rhinitis and nasal anatomic abnormalities. Participation in clinical trial in 30 days prior to study entry;

Ages Eligible for Study
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Minimum Age: 18 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>The patients will take 2 tablets three times a day, as follows: Morning: 1 tablet of the test medication(Desloratadine 5 mg + Prednisolone 20 mg) + 1 tablet of placebo control medication. Afternoon: 1 tablet of placebo test medication + 1 tablet of placebo control medication. Night: 1 tablet of placebo test medication + 1 tablet of placebo control medication. | Drug: Desloratadine + Prednisolone<br>* 1 tablet 3 times a day<br>|
| Active Comparator: Dexchlorpheniramine + Betamethasone<br>The patients will take 2 tablets three times a day, as follows: Morning: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication. Afternoon: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication. Night: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication. | Drug: Dexchlorpheniramine + Betamethasone<br>* 1 tablet 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 |