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| Name | Class |
|---|---|
| Umraniye Education and Research Hospital | OTHER_GOV |
| Diskapi Yildirim Beyazit Education and Research Hospital | OTHER_GOV |
| Antalya Training and Research Hospital | OTHER_GOV |
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This is a prospective, national, randomized, multicenter, parallel group, Phase III study that evaluates the effects of AI201901 in Allergic Rhinitis patients, where they will spray twice a day against azelastine into both nostrils during a 28-day follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azelastine Hydrochloride | Active Comparator | Patients that will receive azelastine hydrochloride are defined as the active control arm. |
|
| AI201901 | Experimental | Patients that will receive AI201901 are defined as the test arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI201901 | Drug | Twice daily inhaled AI201901 for 4 weeks |
| |
| Azelastine Hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Total Nasal Symptom Score | Achieve a statistically significant improvement in the symptoms of allergic rhinitis via Total Nasal Symptom Score (TNSS). | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| TNNSS; Total non nasal symptom score | In non-nasal symptom scores (TNNSS), AI201901 is similar compared to azelastine | 28 days |
| The rhinoconjunctivitis quality of life scale (RQLQ) | The rhinoconjunctivitis quality of life scale (RQLQ) indicates that AI201901 is similar compared to azelastine |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dokuz Eylul University | Izmir | Turkey (Türkiye) |
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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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| ID | Term |
|---|---|
| C020976 | azelastine |
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| Dokuz Eylul University |
| OTHER |
| Ankara City Hospital Bilkent | OTHER |
| Kahramanmaras Sutcu Imam University | OTHER |
| Uludag University | OTHER |
| Karadeniz Technical University | OTHER |
| Kartal Dr. Lütfi Kirdar City Hospital | UNKNOWN |
The first group will receive AI201901 , whereas the second group will receive azelastine hydrochloride. Patients that will receive AI201901 are defined as the test arm and patients that will receive azelastine hydrochloride are defined as the active control arm.
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| Drug |
Twice daily inhaled Azelastine Hydrochloride for 4 weeks |
|
|
| 28 days |
| Odor Visual Analogue Score (VAS) | In Odor Visual Analogue Score (VAS) results, AI201901 is better than azelastine | 28 days |
| Inspiratory peak flow meter (PNIF) | Inspiratory peak flow meter (PNIF) results show that AI201901 is similar compared to azelastine | 28 days |
| Connecticut butanol odor threshold test | Connecticut butanol odor threshold tests show that AI201901 is similar compared to azelastine | 28 days |
| Rhinoscopic Assessment Scale | Results of the Rhinoscopic Assessment Scale show that AI201901 is better than azelastine | 28 days |
| Safety of AI201901 | Demonstration of the safety of AI201901 by comparing the number of participants with treatment-related adverse events in each arm. | 28 days |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |