Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)
Allergic Rhinitis
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility Criteria
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
MAZ-101
DYMISTA®
One applications in each nostril, twice a day.
One applications in each nostril, twice a day.