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

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529229
• Other study ID #: DPREMS1111
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2012
• Last updated: January 14, 2015
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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