National, Multicenter, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)

EMS0422 - AZALEIA

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

2024-09-01

2024-11-01

2025-05-01

Not yet recruiting

Early phase I

514

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;

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2024-02-16