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

The purpose of this study is to evaluate the efficacy and safety of MAZ-101 in the treatment of moderate-severe persistent allergic rhinitis.

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 congestion score of 2 or 3;Randomization Visit: A 12-hour reflective TNSS (AM or PM) ≥ 8 on 3 separate symptoms assessments during the Lead-in Period; an AM or PM 12-hour reflective nasal congestion score 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, may interfere 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, cardiac arrhythmias, glaucoma, ocular herpes simplex, cataracts, hyperthyroidism;Asthma sufferers; respiratory tract infections and lung disease, including chronic obstructive pulmonary disease (COPD);Presence of grade II or III septal deviation and/or presence of nasal polyps or other conditions that determine nasal obstruction;Concomitant chronic or intermittent use of decongestants and/or antihistamines and/or inhaled, oral, intramuscular, intravenous or potent topical corticosteroids;Participants using monoamine oxidase inhibitors (MAOIs);Participants with known allergy or hypersensitivity to the components of the drugs used during the clinical trial;History of alcohol abuse or illicit drug use;Pregnancy or risk of pregnancy and lactating patients;