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

EMS

Status and phase

Not yet enrolling

Phase 3

Conditions

Allergic Rhinitis

Treatments

Drug: DYMISTA®

Drug: MAZ-101association

Study type

Interventional

Funder types

Industry

Identifiers

EMS0422 - AZALEIA

Details and patient eligibility

About

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

Enrollment

514 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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;