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

NCT05214911 | Completed Phase 3

• 1 other identifier: EF177
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• The total nasal symptom score (TNSS)

  Primary objective: Demonstrate the superiority of the experimental drug (FDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA) compared to desloratadine 0.5 mg/mL in alleviating symptoms of moderate/severe allergic rhinitis in children through the absolute variation of the total nasal symptom score (TNSS) five (05) days after the treatment start. The TNSS is determined by the sum of the intensity scores attributed to the symptoms of nasal obstruction, runny nose, nasal itching and sneezing in the last 24 hours. Each symptom is assessed using a 4-point categorical scale (0=absent symptom, 1=mild symptom, 2=moderate symptom, 3=intense symptom).

  five (05) days after the treatment start

Secondary Outcomes (1)

• The total nasal symptom score (TNSS) ( efficacy)

  three (03) days after the treatment start

Study Arms (2)

Experimental drug (Desloratadine 0.5 mg/mL/Prednisolone 4 mg/mL)

EXPERIMENTAL

ADF Group 1 - Eurofarma drug association of Desloratadine 0.5 mg/mL / Prednisolone 4 mg/mL

Drug: Desloratadine , Prednisolone

Active Comparator: Desalex® (Desloratadine 0.5 mg/mL)

ACTIVE COMPARATOR

Desalex® Group 2 - Eurofarma drug Desloratadine 0.5 mg/mL

Drug: Desloratadine

Interventions

Desloratadine , Prednisolone DRUG

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

Experimental drug (Desloratadine 0.5 mg/mL/Prednisolone 4 mg/mL)

Desloratadine DRUG

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

Active Comparator: Desalex® (Desloratadine 0.5 mg/mL)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age ≥ 6 years and ≤ 12 years.
• Diagnosis of moderate to severe persistent allergic rhinitis (PAR) according to ARIA (Allergic Rhinitis and Its Impact on Asthma) criteria.
• Sensitization to aeroallergens confirmed by the presence of a positive result on the immediate skin test (PRICK test) and/or by the presence of specific IgE.
• Total nasal symptom score (TNSS ) ≥ 8 points.
• Symptom intensity score "nasal obstruction" ≥ 2 points.
• Signing of the Informed Consent Form (ICF) by the legal guardian and the Informed Assent Form (IAF) before performing any study procedure.

You may not qualify if:

• Being using or having an indication for antibiotic therapy upon selection for the study.
• Use of prednisolone or other oral corticosteroids in the last seven (07) days.
• Presence of uncontrolled asthma.
• Covid-19 diagnosis within four (04) weeks prior to randomization.
• Positive for SARS-COV-2 rapid antigen test at the time of randomization.
• Known allergy to desloratadine, prednisolone or any component of the product formulations under investigation.
• Presence of systemic fungal infections or uncontrolled infections.
• Presence of any serious or uncontrolled diseases, at the investigator's discretion.
• Presence of pregnancy or lactation.
• At the discretion of the investigator, female participants who are already of childbearing age must confirm the use of contraception or expressly declare that they are not at risk of pregnancy because they do not engage in sexual practices or do so in a non-reproductive manner.
• Participation in a clinical research protocol in the last 6 months, unless, according to the investigator's criteria, their participation in the study could imply a direct benefit for the participant.
• Presence of any condition that, at the investigator's discretion, renders the patient unfit to participate in the study.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Eurofarma Laboratorios S.A

São Paulo, Brazil

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

desloratadine; Prednisolone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind, double-dummy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 31, 2022
• Study Start: July 8, 2024
• Primary Completion: March 23, 2025
• Study Completion: March 23, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-02

Locations

BR (1)