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