Fixed Dose Combination of DESloratadine / PREDnisolone in the Treat. of Moderate - Severe Allergic Rhinitis in Children (DESPRED)
Fixed Dose Combination of DESloratadine / PREDnisolone in the Treat. of Moderate - Severe Allergic Rhinitis in Children (DESPRED)
ClinicalTrials.gov ID: NCT05214911
Sponsor: Eurofarma Laboratorios S.A.
Information provided by: Eurofarma Laboratorios S.A. (Responsible Party)
Last Update Posted: 2023-05-06
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).
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
Intervention / Treatment:
Drug: Desloratadine , Prednisolone
Drug: Desloratadine
| Category | Value |
|---|---|
| Study Start (Estimated) | 2023-10-01 |
| Primary Completion (Estimated) | 2024-10-01 |
| Study Completion (Estimated) | 2025-04-01 |
| Enrollment (Estimated) | 248 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
EF177 |