Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Treatment A: Azelastine 0.15% · 1 trial · 1 indication
Onset of action of azelastine hydrochloride 0.15% nasal spray (Azelastine 0.15%) in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU), measured by a difference from placebo in the change from baseline in patient -assessed instantaneous Total nasal symptom score (TNSS). FDA guideline defines onset of action as the first time point after initiation of treatment when the product demonstrated a greater change from baseline compared to placebo which proved durable. The TNSS is comprised of 4 symptoms from the nose, each scored on a scale of 0 to 3 (0 = none and 3 = severe). The sum of the TNSS contributes to a score ranging from 0 - 12.
| Arm | Type | Description |
|---|---|---|
| Treatment A (Azelair)+Treatment B (Placebo)+Treatment C (Ryaltris), min. 14 days wash-out period | EXPERIMENTAL | Cross-over design |
| Treatment B (Placebo)+Treatment C (Ryaltris)+Treatment A (Azelair), min. 14 days of wash-out period | EXPERIMENTAL | Cross-over design |
| Treatment C (Ryaltris)+Treatment A (Azelair)+Treatment B (Placebo), min. 14 days of wash-out period | EXPERIMENTAL | Cross-over design |
| Treatment A (Azelair)+Treatment C (Ryaltris)+Treatment B (Placebo), min. 14 days of wash-out period | EXPERIMENTAL | Cross-over design |
| Treatment B (Placebo)+Treatment A (Azelair)+Treatment C (Ryaltris), min.14 days of wash-out period | EXPERIMENTAL | Cross-over design |
| Treatment C (Ryaltris)+Treatment B (Placebo)+Treatment A (Azelair), min. 14 days of wash-out period | EXPERIMENTAL | Cross-over design |
| Name | Type | Description |
|---|---|---|
| Treatment A: Azelastine hydrochloride 0.15% nasal spray (Azelair) | DRUG | 2 sprays per nostril of Azelastine 0.15% twice daily. Total dose of active drug: 1644 mcg azelastine hydrochloride per day |
| Treatment B: Placebo (Azelastine 0.15% vehicle) nasal spray | DRUG | 2 sprays per nostril of Placebo twice daily. |
| Treatment C: Ryaltris (Active Control) - mometasone furoate monohydrate and olopatadine hydrochloride nasal spray | DRUG | 2 sprays per nostril of Ryaltris twice daily. Total dose of active drug: 200 mcg mometasone furoate and 4800 mcg olopatadine per day |
Main Inclusion Criteria: * Male or female subjects (childbearing and non-childbearing potential, non-childbearing potential defined as females with no menstruation for at least 1 year at screening and documented FSH \> 35 IU/L) aged 18 to 55 years (inclusive) at screening. * History of SAR to ragwe...