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This study is to evaluate the equivalence of generic Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray with that of the marketed drug, Dymista™ Nasal Spray, in the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic Azelastine Hydrochloride and Fluticasone Propionate nasal spray compared with Dymista™ nasal spray.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azelastine HCl and Fluticasone Propionate Nasal Spray | Experimental | The investigational product was administered via nasal inhalation with one spray in each nostril twice daily. Batch Number KL1981, Expiry Date Mar 2015. |
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| Dymista™ Nasal Spray | Active Comparator | The reference product was administered via nasal inhalation with one spray in each nostril twice daily. Batch Number G30349, Expiry Date Mar 2015. |
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| Placebo Nasal Spray | Placebo Comparator | The placebo was administered via nasal inhalation with one spray in each nostril twice daily. Batch Number KL0781, Expiry Date Mar 2015. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray | Drug | During the placebo lead-in period, the placebo nasal spray was administered via nasal inhalation with one spray in each nostril twice daily for 7days. During the randomized treatment period, the investigational products (experimental, active comparator and placebo nasal spray) were administered via nasal inhalation with one spray in each nostril twice daily for 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment of Seasonal Allergic Rhinitis (Change from baseline in the combined reflective TNSS (combined AM and PM reflective scores of runny nose, nasal congestion, nasal itchiness, and sneezing) | Change from baseline in the combined AM and PM instantaneous scores of runny nose, nasal congestion, nasal itchiness, and sneezing. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment of Seasonal Allergic Rhinitis (Change from baseline in the combined AM and PM instantaneous scores of runny nose, nasal congestion, nasal itchiness, and sneezing.) | Change from baseline in the combined AM and PM instantaneous scores of runny nose, nasal congestion, nasal itchiness, and sneezing. | 2 months |
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Inclusion Criteria:
Subjects who met all of the following criteria were eligible for inclusion in the study:
Exclusion Criteria:
Subjects who met any of the following criteria were excluded from the study:
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|
| Dymista™ Nasal Spray | Drug |
|
| Placebo | Drug |
|
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C020976 | azelastine |
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