Status:
COMPLETED
Fixed Dose Combination of Desloratadine / Prednisolone in the Treatment of Moderate Severe Allergic Rhinitis in Children
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
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 fro...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2025
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT05214911
Start Date
July 8 2024
End Date
March 23 2025
Last Update
April 17 2025
Active Locations (1)
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1
Eurofarma Laboratorios S.A
São Paulo, Brazil