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

Primary Purpose

Allergic Rhinitis

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MAZ-101association
DYMISTA®
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MAZ-101

    DYMISTA®

    Arm Description

    One applications in each nostril, twice a day.

    One applications in each nostril, twice a day.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Change from baseline in AM+PM rTOSS (reflective total ocular symptom score).
    Change from baseline in 12-hour reflective total ocular symptom score (rTOSS) consisting of itching/burning, tearing/watering, and redness scored twice daily (AM and PM) in diary for the entire 28 day study period. The measurement scale is 0 to 18 so that the higher the number the worse the symptom.
    Change from baseline in AM + PM: rTNSS (reflective total nasal symptoms score) plus rTOSS (reflective total ocular symptom score).
    Change from baseline in 12-hour rTNSS plus rTOSS consisting of nasal congestion,runny nose, itchy nose and sneezing that represents rTNSS and itching/burning, tearing/watering, and redness that represents rTOSS scored twice daily (AM and PM) in diary for the entire 28 day study period. The measurement scale is 0 to 24 of rTNSS plus 0 to 18 of rTOSS. Then, the (rTNSS plus rTOSS ) measurement scale is 0 to 42 so that the higher the number the worse the symptom.
    Change from baseline in reflective individual nasal symptom scores.
    Change from baseline in the 12-hour reflective individual nasal symptom scores consisting of nasal congestion,runny nose, itchy nose, sneezing scored twice daily (AM and PM) in diary for the entire 28 day study period. The measurement scale is 0 to 3 in each symptom so that the higher the number the worse the symptom.
    Change from baseline in reflective individual ocular symptom scores.
    Change from baseline in the 12-hour reflective individual ocular symptom scores consisting of itching/burning, tearing/watering, and redness scored twice daily (AM and PM) in diary for the entire 28 day study period. The measurement scale is 0 to 3 in each symptom so that the higher the number the worse the symptom.
    Change from baseline in the Rhinoconjunctivitis Quality of Life Questionnaire for adults (RQLQ) or Rhinoconjunctivitis Quality of Life Questionnaire for adolescents (AdolRQLQ).
    Change compared to baseline in the general score of the Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) or adolescent (AdoRQLQ) after 28 days os treatment. The RQLQ has 28 questions and the AdolRQLQ has 25 questions. Participants will respond to each question on a 7-point scale (0 = not at all impaired to 6 = severely impaired) according to how bothered the participants were by their rhinoconjunctivitis during the past week.
    Number of days without nasal symptoms
    Number of days without nasal symptoms (rTNSS = 0) for the entire 28-day study period.

    Full Information

    First Posted
    December 16, 2022
    Last Updated
    January 12, 2023
    Sponsor
    EMS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05684380
    Brief Title
    Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)
    Official Title
    National, Multicenter, Randomized, Double-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    May 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EMS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Rhinitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    514 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MAZ-101
    Arm Type
    Experimental
    Arm Description
    One applications in each nostril, twice a day.
    Arm Title
    DYMISTA®
    Arm Type
    Active Comparator
    Arm Description
    One applications in each nostril, twice a day.
    Intervention Type
    Drug
    Intervention Name(s)
    MAZ-101association
    Intervention Description
    Experimental drug
    Intervention Type
    Drug
    Intervention Name(s)
    DYMISTA®
    Intervention Description
    Active comparator
    Primary Outcome Measure Information:
    Title
    Change from baseline in AM+PM rTNSS (reflective total nasal symptoms score).
    Description
    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.
    Time Frame
    28 days.
    Secondary Outcome Measure Information:
    Title
    Change from baseline in AM+PM rTOSS (reflective total ocular symptom score).
    Description
    Change from baseline in 12-hour reflective total ocular symptom score (rTOSS) consisting of itching/burning, tearing/watering, and redness scored twice daily (AM and PM) in diary for the entire 28 day study period. The measurement scale is 0 to 18 so that the higher the number the worse the symptom.
    Time Frame
    28 days.
    Title
    Change from baseline in AM + PM: rTNSS (reflective total nasal symptoms score) plus rTOSS (reflective total ocular symptom score).
    Description
    Change from baseline in 12-hour rTNSS plus rTOSS consisting of nasal congestion,runny nose, itchy nose and sneezing that represents rTNSS and itching/burning, tearing/watering, and redness that represents rTOSS scored twice daily (AM and PM) in diary for the entire 28 day study period. The measurement scale is 0 to 24 of rTNSS plus 0 to 18 of rTOSS. Then, the (rTNSS plus rTOSS ) measurement scale is 0 to 42 so that the higher the number the worse the symptom.
    Time Frame
    28 days.
    Title
    Change from baseline in reflective individual nasal symptom scores.
    Description
    Change from baseline in the 12-hour reflective individual nasal symptom scores consisting of nasal congestion,runny nose, itchy nose, sneezing scored twice daily (AM and PM) in diary for the entire 28 day study period. The measurement scale is 0 to 3 in each symptom so that the higher the number the worse the symptom.
    Time Frame
    28 days.
    Title
    Change from baseline in reflective individual ocular symptom scores.
    Description
    Change from baseline in the 12-hour reflective individual ocular symptom scores consisting of itching/burning, tearing/watering, and redness scored twice daily (AM and PM) in diary for the entire 28 day study period. The measurement scale is 0 to 3 in each symptom so that the higher the number the worse the symptom.
    Time Frame
    28 days.
    Title
    Change from baseline in the Rhinoconjunctivitis Quality of Life Questionnaire for adults (RQLQ) or Rhinoconjunctivitis Quality of Life Questionnaire for adolescents (AdolRQLQ).
    Description
    Change compared to baseline in the general score of the Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) or adolescent (AdoRQLQ) after 28 days os treatment. The RQLQ has 28 questions and the AdolRQLQ has 25 questions. Participants will respond to each question on a 7-point scale (0 = not at all impaired to 6 = severely impaired) according to how bothered the participants were by their rhinoconjunctivitis during the past week.
    Time Frame
    28 days.
    Title
    Number of days without nasal symptoms
    Description
    Number of days without nasal symptoms (rTNSS = 0) for the entire 28-day study period.
    Time Frame
    28 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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;

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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