Table 3.
Contribution of MP-AzeFlu’s formulation to its superior efficacy over fluticasone propionate (FP), measured for reflective total nasal symptom score (rTNSS), reflective total ocular symptom score (rTOSS), and time to achieve ≥ 50% reduction from baseline in rTNSS
| Study MP4001 [118] (effect of formulation included) | Studies MP4002/MP4004/MP4006 [121] (effect of formulation removed) | Formulation effect | |||||
|---|---|---|---|---|---|---|---|
| Parameter | MP-AzeFlu n = 153 |
Marketed FP n = 151 |
MP-AzeFlu–FP | MP-AzeFlu n = 848 |
Reformulated-FP n = 846 |
MP-AzeFlu–FP | |
| LS mean rTNSS (95% CI) | − 5.31 | − 3.84 | − 1.47 (− 2.44, − 0.50) p = 0.003 |
− 5.56 | − 4.80 | − 0.76 (− 1.18, − 0.34) p = 0.0004 |
0.71 points |
| LS mean rTOSS (95% CI) | − 3.33 | − 2.17 | − 1.17 (− 1.91, − 0.42) p = 0.002 |
− 3.18 | − 2.71 | − 0.47 (− 0.78, − 0.16) p = 0.0030 |
0.71 points |
| Patients at day 14, % | No. days’ advantage over FP | Patients at day 14, % | No. days’ advantage over FP | ||||
|---|---|---|---|---|---|---|---|
| ≥ 50 reduction from baseline rTNSS | 49.1 | 38.2 | ≤ 6 days p = 0.0284 |
~ 50 | ≈ 45 | ≤ 3 days (significance not provided) | ≤ 3 days |
LS least squares, MP-AzeFlu a novel formulation of an intranasal antihistamine, azelastine hydrochloride, and an intranasal corticosteroid, fluticasone propionate, in a single spray