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

Inclusion Criteria:

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

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

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

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

• In the opinion of the Principal Investigator or treating physician, the patient isindicated for treatment with the investigational product and may derive clinicalbenefit from it.

Exclusion Criteria:

• 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 tobecome pregnant during the course of the study.

• Acute or chronic lower or upper respiratory tract infections, such as the commoncold, influenza, pneumonia, bronchitis, or chronic sinusitis.

• History of non-allergic rhinitis, such as chronic non-allergic rhinitis,drug-induced rhinitis, atrophic rhinitis, hormonal rhinitis, or unilateral rhinitis,as reported in the medical history or patient interview.

• History of nasal polyposis, primary ciliary dyskinesia syndrome, and/or non-allergicrhinitis with eosinophilia syndrome (NARES).

• Current smokers, or history of alcohol and/or drug abuse in the past year accordingto DSM-V criteria.

• History of seizure disorders, status epilepticus, or generalized tonic-clonicseizures.

• History of chronic hepatic failure classified as Child-Pugh C, as reported in themedical history or patient interview.

• History of chronic renal failure (glomerular filtration rate < 30 mL/min/1.73 m²),as reported in the medical history or patient interview.

• Any condition, in the investigator's opinion, that affects prognosis or precludesoutpatient management, which must be evaluated by the principal investigator todetermine the subject's eligibility.

• History of severe, progressive, unstable, or advanced disease of any kind that couldinterfere with efficacy and safety evaluations or pose a risk to the patient.

• Oncology patients (except those with basal cell skin cancer) or patients withserious illnesses who, in the investigator's opinion, have a poor prognosis or lifeexpectancy of less than one year, including those with mental health disorders.

• Active participation in another clinical trial involving an investigationaltreatment or participation in any clinical study within the previous two weeks.

• Patients whose participation in the study may be influenced (e.g., employees of theresearch center or sponsor, incarcerated individuals, etc.).

• Patients with symptoms suggestive of active COVID-19 infection (e.g., fever, cough,dyspnea) and/or contact within the past 14 days with a suspected or confirmedCOVID-19 case and/or a positive COVID-19 test.