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

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS

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;