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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Desloratadine , Prednisolone
* Drug: Desloratadine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 (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). | 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 12 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 |