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

EMS

Status and phase

Completed

Phase 3

Conditions

Allergic Rhinitis

Treatments

Drug: Dexchlorpheniramine + Betamethasone

Drug: Desloratadine + Prednisolone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01529229

DPREMS1111

Details and patient eligibility

About

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.

Full 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.

Enrollment

210 patients

Sex

All

Ages

2 to 11 years old

Volunteers

No Healthy Volunteers

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.