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

Phase 3

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Desloratadine + Prednisolone; Drug: Dexchlorpheniramine + Betamethasone

• Registration Number: NCT01529229
• Lead Sponsor: EMS

Brief Summary

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

* 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.

Study Timeline

• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-08
• Study Start: 2013-11
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-14
• Last Update Posted: 2015-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desloratadine + Prednisolone	Desloratadine + Prednisolone	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.
Dexchlorpheniramine + Betamethasone	Dexchlorpheniramine + Betamethasone	Dexchlorpheniramine (0.4 mg/ml) + Betamethasone (0.05 mg/ml) three times a day - bottles 1, 2 and 3.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety will be evaluated by the adverse events occurrences	7 days	Adverse events will be collected and followed in order to evaluate safety and tolerability