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

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Dexchlorpheniramine + Betamethasone

Desloratadine + Prednisolone

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Desloratadine + Prednisolone

Dexchlorpheniramine + Betamethasone

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety will be evaluated by the adverse events occurrences

Adverse events will be collected and followed in order to evaluate safety and tolerability

Full Information

NCT ID

NCT01529229

First Posted

February 6, 2012

Last Updated

January 14, 2015

Sponsor

EMS

1. Study Identification

Unique Protocol Identification Number

NCT01529229

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMS

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Desloratadine + Prednisolone

Arm Type

Experimental

Arm Description

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.

Arm Title

Dexchlorpheniramine + Betamethasone

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexchlorpheniramine + Betamethasone

Intervention Description

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

Intervention Name(s)

Desloratadine + Prednisolone

Intervention Description

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

Primary Outcome Measure Information:

Title

Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score

Description

The mean variability of nasal symptoms score observed between visit 1 and visit 2 will be used as the primary endpoint of clinical efficacy.

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Safety will be evaluated by the adverse events occurrences

Description

Adverse events will be collected and followed in order to evaluate safety and tolerability

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dirceu Solé, MD

Organizational Affiliation

Federal University of São Paulo

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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