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

A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Moderate - Severe Persistent Allergic Rhinitis

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Desloratadine + Prednisolone; Drug: Dexchlorpheniramine + Betamethasone

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: Dexchlorpheniramine + Betamethasone; Dexchlorpheniramine (0.4 mg/ml) + Betamethasone (0.05 mg/ml) three times a day - bottles 1, 2 and 3.	Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety will be evaluated by the adverse events occurrences	Adverse events will be collected and followed in order to evaluate safety and tolerability	7 days

Collaborators and Investigators

• Sponsor: EMS
• Investigators: Principal Investigator: Dirceu Solé, MD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: February 6, 2012
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Estimate): January 15, 2015
• Last Update Submitted That Met QC Criteria: January 14, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Antagonists; Cholinergic Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anti-Asthmatic Agents; Respiratory System Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Prednisolone; Betamethasone; Desloratadine; Dexchlorpheniramine
• Other Study ID Numbers: DPREMS1111