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

NCT05684380 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: EMS0422 - AZALEIA
• Study Type: interventional
• Target: 514
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in AM+PM rTNSS (reflective total nasal symptoms score).

  Change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 28 day study period. The measurement scale is 0 to 24 so that the higher the number the worse the symptom.

  28 days.

Secondary Outcomes (6)

• Change from baseline in AM+PM rTOSS (reflective total ocular symptom score).

  28 days.

• Change from baseline in AM + PM: rTNSS (reflective total nasal symptoms score) plus rTOSS (reflective total ocular symptom score).

  28 days.

• Change from baseline in reflective individual nasal symptom scores.

  28 days.

• Change from baseline in reflective individual ocular symptom scores.

  28 days.

• Change from baseline in the Rhinoconjunctivitis Quality of Life Questionnaire for adults (RQLQ) or Rhinoconjunctivitis Quality of Life Questionnaire for adolescents (AdolRQLQ).

  28 days.

Study Arms (2)

MAZ-101

EXPERIMENTAL

One applications in each nostril, twice a day.

Drug: MAZ-101association

DYMISTA®

ACTIVE COMPARATOR

One applications in each nostril, twice a day.

Drug: DYMISTA®

Interventions

MAZ-101association DRUG

Experimental drug

MAZ-101

DYMISTA® DRUG

Active comparator

DYMISTA®

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 13, 2023
• Study Start: September 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share