Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)

Inclusion Criteria:

• Participants of both sexes, with age greater than or equal to 12 years;
• Clinical diagnosis of moderate-severe persistent for at least 1 year;
• Screening Visit: A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestionscore of 2 or 3;
• Randomization Visit: A 12-hour reflective TNSS (AM or PM) ≥ 8 on 3 separate symptomsassessments during the Lead-in Period; an AM or PM 12-hour reflective nasal congestionscore of 2 or 3 must have been recorded on 3 separate symptom assessments;
• Present skin sensitization test to at least one aeroallergen.

Exclusion Criteria:

• Any clinical and laboratory findings that, in the judgment of the investigator, mayinterfere with the safety of research participants;
• Other clinical forms of rhinitis;
• Subjects receiving immunotherapy;
• Presence of nasal polyposis;
• Patients with severe arterial hypertension, severe coronary diseases, cardiacarrhythmias, glaucoma, ocular herpes simplex, cataracts, hyperthyroidism;
• Asthma sufferers; respiratory tract infections and lung disease, including chronicobstructive pulmonary disease (COPD);
• Presence of grade II or III septal deviation and/or presence of nasal polyps or otherconditions that determine nasal obstruction;
• Concomitant chronic or intermittent use of decongestants and/or antihistamines and/orinhaled, oral, intramuscular, intravenous or potent topical corticosteroids;
• Participants using monoamine oxidase inhibitors (MAOIs);
• Participants with known allergy or hypersensitivity to the components of the drugsused during the clinical trial;
• History of alcohol abuse or illicit drug use;
• Pregnancy or risk of pregnancy and lactating patients;