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

NCT ID: NCT05684380

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 514 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-05-31

Brief 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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MAZ-101

One applications in each nostril, twice a day.

Group Type: EXPERIMENTAL

MAZ-101association

Intervention Type: DRUG

Experimental drug

DYMISTA®

One applications in each nostril, twice a day.

Group Type: ACTIVE_COMPARATOR

DYMISTA®

Intervention Type: DRUG

Active comparator

Interventions

MAZ-101association

Experimental drug

Intervention Type: DRUG

DYMISTA®

Active comparator

Intervention Type: DRUG

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;

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EMS0422 - AZALEIA

Identifier Type: -

Identifier Source: org_study_id