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Fixed Dose Combination of DESloratadine / PREDnisolone in the Treat. of Moderate - Severe Allergic Rhinitis in Children (DESPRED)

Primary Purpose

Allergic Rhinitis

Status

Not yet recruiting

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Desloratadine , Prednisolone

Desloratadine

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 (Annex 1).
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 on the radioallergoabsorbent test (RAST) .
Total nasal symptom score (TNSS ) ≥ 8 points (Annex 2).
Symptom intensity score "nasal obstruction" ≥ 2 points.
Correct use of optimized treatment for PER, including use of intranasal corticosteroids, as assessed by the investigator.
Signing of the Informed Consent Form (ICF) and the Informed Assent Form (IAF) before performing any study procedure.

Exclusion Criteria:

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.
Asthma diagnosis.
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.
Women of childbearing age who do not agree to use a contraceptive method known to be effective, unless surgically sterile or who expressly declare themselves exempt from the risk of pregnancy for not engaging in sexual practices or exercising them in a non-reproductive manner.
Participation in a clinical research protocol in the last 12 months, unless, at the investigator's discretion, their participation in the study may incur a direct benefit to the participant.
Presence of any condition that, at the investigator's discretion, renders the patient unfit to participate in the study.

Sites / Locations

Eurofarma Laboratorios S.A

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 (Leg®) 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 12 hours. Each symptom is assessed using a 4-point categorical scale (0=absent symptom, 1=mild symptom, 2=moderate symptom, 3=intense symptom).

Secondary Outcome Measures

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 12 hours. Each symptom is assessed using a 4-point categorical scale (0=absent symptom, 1=mild symptom, 2=moderate symptom, 3=intense symptom).

Full Information

NCT ID

NCT05214911

First Posted

December 13, 2021

Last Updated

May 4, 2023

Sponsor

Eurofarma Laboratorios S.A.

1. Study Identification

Unique Protocol Identification Number

NCT05214911

Brief Title

Fixed Dose Combination of DESloratadine / PREDnisolone in the Treat. of Moderate - Severe Allergic Rhinitis in Children

Acronym

DESPRED

Official Title

Multicenter, Randomized, Parallel, Double-blind, Comparative Study of the Superiority of the FDC of Desloratadine 0.5 mg/mL and Prednisolone 4 mg/mL Versus Desloratadine 0.5 mg/mL in the Treat. of Persistent Allergic Rhinitis in Children

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2023 (Anticipated)

Primary Completion Date

October 1, 2024 (Anticipated)

Study Completion Date

April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eurofarma Laboratorios S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Multicenter, randomized, parallel-group, double-blind, 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 (Leg®) 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).

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, 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 (Leg® - Eurofarma Laboratórios SA), 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).

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

ParticipantInvestigator

Masking Description

Double-blind

Allocation

Randomized

Enrollment

248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Desloratadine , Prednisolone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Desloratadine

Intervention Description

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

Primary Outcome Measure Information:

Title

The total nasal symptom score (TNSS)

Description

Time Frame

five (05) days after the treatment start

Secondary Outcome Measure Information:

Title

The total nasal symptom score (TNSS) ( efficacy)

Description

Time Frame

three (03) days after the treatment start

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 (Annex 1). 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 on the radioallergoabsorbent test (RAST) . Total nasal symptom score (TNSS ) ≥ 8 points (Annex 2). Symptom intensity score "nasal obstruction" ≥ 2 points. Correct use of optimized treatment for PER, including use of intranasal corticosteroids, as assessed by the investigator. Signing of the Informed Consent Form (ICF) and the Informed Assent Form (IAF) before performing any study procedure. Exclusion Criteria: 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. Asthma diagnosis. 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. Women of childbearing age who do not agree to use a contraceptive method known to be effective, unless surgically sterile or who expressly declare themselves exempt from the risk of pregnancy for not engaging in sexual practices or exercising them in a non-reproductive manner. Participation in a clinical research protocol in the last 12 months, unless, at the investigator's discretion, their participation in the study may incur a direct benefit to the participant. Presence of any condition that, at the investigator's discretion, renders the patient unfit to participate in the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Edilene Macedo, Analyst

Phone

+55 11 50908422

edilene.macedo@eurofarma.com

First Name & Middle Initial & Last Name or Official Title & Degree

Natalia Gianni, Analyst

Phone

41449500

natalia.gianni@eurofarma.com

Facility Information:

Facility Name

Eurofarma Laboratorios S.A

City

São Paulo

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Fixed Dose Combination of DESloratadine / PREDnisolone in the Treat. of Moderate - Severe Allergic Rhinitis in Children

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