NCT06916884

Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine

Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine as Treatment in Patients With Allergic Rhinitis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Phase IIIb , longitudinal, multicenter, randomized, double-blind, to evaluate efficacy and safety of the fixed-dose combination of Desloratadine 5 mg / Betamethasone 0.25 mg versus Desloratadine 5 mg monotherapy as treatment for symptoms associated with allergic rhinitis.

Detailed description

Nasal symptom changes will be assessed daily over a 10-day intervention period using the Total Nasal Symptom Score (TNSS) for allergic rhinitis. Patients will complete the first questionnaire during the randomization visit, followed by daily entries each night before bedtime using a patient diary. The final assessment will be completed during the study's end-of-treatment visit. Quality of life, global clinical impression, and patient global assessment will be evaluated during in-person visits conducted at baseline, Day 5, and Day 10. The incidence of adverse events throughout the study will be analyzed by treatment group and reported as frequencies and percentages. Events will be classified according to frequency, seriousness, severity, and their relationship to the investigational product.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Desloratadine / Betamethasone in fixed dose	1 tablet, once a day of 5 mg / 0.25 mg
DRUG	Desloratadine	1 tablet, once a day of 5 mg

Timeline

• Start date: 2024-11-11
• Primary completion: 2025-05-11
• Completion: 2025-06-11
• First posted: 2025-04-08
• Last updated: 2025-04-08

Locations

1 site across 1 country: Mexico