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

NCT ID: NCT01529229

Last Updated: 2015-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-10-31

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Desloratadine + Prednisolone

Intervention Type: DRUG

Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day

Dexchlorpheniramine + Betamethasone

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

Group Type: ACTIVE_COMPARATOR

Dexchlorpheniramine + Betamethasone

Intervention Type: DRUG

Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day

Interventions

Dexchlorpheniramine + Betamethasone

Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day

Intervention Type: DRUG

Desloratadine + Prednisolone

Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirceu Solé, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Other Identifiers

DPREMS1111

Identifier Type: -

Identifier Source: org_study_id