Clinical trial NCT05684380: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2023-01-13
Enrollment: 514
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Change from baseline in AM+PM rTNSS (reflective total nasal symptoms score).
timeFrame: 28 days.
Secondary outcomes:
measure: Change from baseline in AM+PM rTOSS (reflective total ocular symptom score).
timeFrame: 28 days.
measure: Change from baseline in AM + PM: rTNSS (reflective total nasal symptoms score) plus rTOSS (reflective total ocular symptom score).
timeFrame: 28 days.
measure: Change from baseline in reflective individual nasal symptom scores.
timeFrame: 28 days.
measure: Change from baseline in reflective individual ocular symptom scores.
timeFrame: 28 days.
measure: Change from baseline in the Rhinoconjunctivitis Quality of Life Questionnaire for adults (RQLQ) or Rhinoconjunctivitis Quality of Life Questionnaire for adolescents (AdolRQLQ).
timeFrame: 28 days.
measure: Number of days without nasal symptoms
timeFrame: 28 days.
Other outcomes:
Locations:
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References: