Comparison of Desloratadine Associated With Prednisolone (Tablet)Versus Dexchlorpheniramine Associated With Betamethasone (Tablet) for Adult Persistent Allergic Rhinitis Treatment

Phase 3

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

• Registration Number: NCT01720485
• 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 in Adults.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-02
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-09-25
• Study Start: 2013-10
• Primary Completion: 2013-12
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 234

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desloratadine + Prednisolone	Desloratadine + Prednisolone	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.
Dexchlorpheniramine + Betamethasone	Dexchlorpheniramine + Betamethasone	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.

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

Trial Locations

Locations (1)

IMA - Instituto de Pesquisa Clínica e Medicina Avançada; 🇧🇷 São Paulo, Brazil