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COMPLETED
NCT05214911
PHASE3

Fixed Dose Combination of Desloratadine / Prednisolone in the Treatment of Moderate Severe Allergic Rhinitis in Children

Sponsor: Eurofarma Laboratorios S.A.

View on ClinicalTrials.gov

Summary

Multicenter, randomized, parallel-group, double-blind, double-dummy, comparative clinical trial of the superiority of the fixed-dose combination of desloratadine 0.5 mg/mL and prednisolone 4 mg/mL from Eurofarma Laboratórios SA versus desloratadine 0.5 mg/mL in the treatment of moderate to severe persistent allergic rhinitis in children aged 6 to 12 years. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Official title: Multicenter,Randomized, Parallel,Double-blind, Comparative Study of the Superiority of the Desloratadine 0.5mg/mL and Prednisolone 4 mg/mL Versus Desloratadine 0.5mg/mL in the Treatment of Persistent Allergic Rhinitis in Children (DESPRED)

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

262

Start Date

2024-07-08

Completion Date

2025-03-23

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

DRUG

Desloratadine , Prednisolone

FDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA

DRUG

Desloratadine

Desloratadine 0.5 mg/mL (Desalex® - Eurofarma Laboratórios SA)

Locations (1)

Eurofarma Laboratorios S.A

São Paulo, Brazil