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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Chlorpheniramine; Desloratadine; Dexchlorpheniramine; Loratadine; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.