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

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)

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).

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Desloratadine , Prednisolone; Drug: Desloratadine

Detailed Description

Desloratadine and prednisolone are active pharmaceutical ingredients (APIs) already registered in the country as monodrugs. These products are widely used and their efficacy and safety are well known in daily clinical practice in the approved indications.

Once confirmed the absence of pharmacokinetic interaction between desloratadine and prednisolone in relative bioavailability studies, this phase 3 study will be conducted with the objective of demonstrating the superiority of the new FDC containing desloratadine and prednisolone over the isolated administration of desloratadine in treatment from moderate to severe allergic rhinitis in children. The aim is to provide a new effective, safe and well-tolerated therapeutic option for dealing with these cases.

Multicenter, randomized, parallel group, double blind, double-dummy, superiority comparative clinical trial.

Children aged ≥ 6 years and < 12 years with moderate to severe persistent allergic rhinitis unresponsive to optimal treatment, including daily use of intranasal corticosteroids, will be randomized in a 1:1 ratio to receive FDC desloratadine 0.5mg/mL/prednisolone 4mg/mL - gel for oral administration by Eurofarma Laboratórios SA (experimental drug) or desloratadine 0.5mg/mL - syrup, for five (05) days.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Eurofarma Laboratórios S.A

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 6 years and ≤ 12 years.
2. Diagnosis of moderate to severe persistent allergic rhinitis (PAR) according to ARIA (Allergic Rhinitis and Its Impact on Asthma) criteria.
3. 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.
4. Total nasal symptom score (TNSS ) ≥ 8 points.
5. Symptom intensity score "nasal obstruction" ≥ 2 points.
6. Signing of the Informed Consent Form (ICF) by the legal guardian and the Informed Assent Form (IAF) before performing any study procedure.

Exclusion Criteria:

1. Being using or having an indication for antibiotic therapy upon selection for the study.
2. Use of prednisolone or other oral corticosteroids in the last seven (07) days.
3. Presence of uncontrolled asthma.
4. Covid-19 diagnosis within four (04) weeks prior to randomization.
5. Positive for SARS-COV-2 rapid antigen test at the time of randomization.
6. Known allergy to desloratadine, prednisolone or any component of the product formulations under investigation.
7. Presence of systemic fungal infections or uncontrolled infections.
8. Presence of any serious or uncontrolled diseases, at the investigator's discretion.
9. Presence of pregnancy or lactation.
10. 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.
11. 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.
12. Presence of any condition that, at the investigator's discretion, renders the patient unfit to participate in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental drug (Desloratadine 0.5 mg/mL/Prednisolone 4 mg/mL); ADF Group 1 - Eurofarma drug association of Desloratadine 0.5 mg/mL / Prednisolone 4 mg/mL	Drug: Desloratadine , Prednisolone; FDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA
Active Comparator: Active Comparator: Desalex® (Desloratadine 0.5 mg/mL); Desalex® Group 2 - Eurofarma drug Desloratadine 0.5 mg/mL	Drug: Desloratadine; Desloratadine 0.5 mg/mL (Desalex® - Eurofarma Laboratórios SA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total nasal symptom score (TNSS) ( efficacy)	Secondary objectives: To compare the efficacy of the experimental drug (FDC desloratadine 0.5 mg/mL/prednisolone 4 mg/mL from Eurofarma Laboratórios SA) against desloratadine 0.5 mg/mL in alleviating symptoms of moderate/severe allergic rhinitis in children through TNSS. 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).	three (03) days after the treatment start

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Actual): March 23, 2025
• Study Completion (Actual): March 23, 2025

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dermatologic Agents; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Anti-Allergic Agents; Antipruritics; Cholinergic Antagonists; Cholinergic Agents; Histamine H1 Antagonists; Histamine H1 Antagonists, Non-Sedating; Prednisolone; Loratadine; Desloratadine
• Other Study ID Numbers: EF177

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No