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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLaboratorios Silanes S.A. de C.V.

About this trial

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.

Eligibility criteria

Qualifiers

Willing to participate in the study and able to provide written informed consent.

Clinical diagnosis (based on medical history and physical examination) of active allergic rhinitis at study entry.

Patients presenting with moderate to severe nasal symptoms, with a Total Nasal Symptom Score (TNSS) ≥5.

In the case of women of childbearing potential who are sexually active, the use of an acceptable contraceptive method (barrier and/or hormonal), as determined by the investigator.

Disqualifiers

Patients for whom the investigational drug is medically contraindicated.

Known allergy or hypersensitivity to the active ingredient, study medications, related products, or excipients.

History of nasal trauma (surgical or accidental) within the past week.

Positive pregnancy test, pregnant or breastfeeding women, or women planning to become pregnant during the course of the study.

Trial design

Treatments tested in this trial

  • Desloratadine / Betamethasone in fixed dose
  • Desloratadine

Treatment groups

70 Participants
are divided into 2 treatment groups