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Not yet recruitingNCT05684380Updated Feb 16, 2024

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

A Phase 3 interventional study of MAZ-101association and DYMISTA® in Allergic Rhinitis, sponsored by EMS. Not yet recruiting. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-02-16.

Sponsored by EMS · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
514
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Rhinitis
03

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
514 participants (estimated)

Study arms

  • Experimental
    MAZ-101

    One applications in each nostril, twice a day.

    Drug: MAZ-101association

  • Active comparator
    DYMISTA®

    One applications in each nostril, twice a day.

    Drug: DYMISTA®

Interventions

  • DrugMAZ-101association

    Experimental drug

  • DrugDYMISTA®

    Active comparator

05

What researchers measure

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.

    Time frame: 28 days.

Secondary outcomes

  1. 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.

    Time frame: 28 days.

  2. 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.

    Time frame: 28 days.

  3. 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.

    Time frame: 28 days.

  4. 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.

    Time frame: 28 days.

  5. 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.

    Time frame: 28 days.

  6. Number of days without nasal symptoms

    Number of days without nasal symptoms (rTNSS = 0) for the entire 28-day study period.

    Time frame: 28 days.

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05684380
Lead sponsor
EMS
Responsible party
Sponsor
First posted
Jan 13, 2023
Start date
Sep 2024 (estimated)
Primary completion
Nov 2024 (estimated)
Completion
May 2025 (estimated)
Last update
Feb 16, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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