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The purpose of this study is to evaluate the efficacy and safety of MAZ-101 in the treatment of moderate-severe persistent allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAZ-101 | Experimental | One applications in each nostril, twice a day. |
|
| DYMISTA® | Active Comparator | One applications in each nostril, twice a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAZ-101association | Drug | Experimental drug |
| |
| DYMISTA® |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Drug |
Active comparator |
|
| 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. | 28 days. |
| 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. | 28 days. |
| 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. | 28 days. |
| 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. | 28 days. |
| Number of days without nasal symptoms | Number of days without nasal symptoms (rTNSS = 0) for the entire 28-day study period. | 28 days. |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |