Table 4.
Overview of most frequent treatment-emergent adverse events (2-week studies)a
| Preferred term, n (%) | MP-AzeFlu | FP | AZE | PLA |
|---|---|---|---|---|
| MP 4001b | n=153 | n=153 | n=152 | n=151 |
| Dysgeusia (bitter taste) | 11 (7.2) | 0 (0.0) | 3 (2.0) | 0 (0.0) |
| Epistaxis | 6 (3.9) | 6 (3.9) | 4 (2.6) | 5 (3.3) |
| Headache | 4 (2.6) | 6 (3.9) | 2 (1.3) | 2 (1.3) |
| MP 4002c | n=207 | n=207 | n=208 | n=210 |
| Dysgeusia (bitter taste) | 5 (2.4) | 2 (1.0) | 7 (3.4) | 1 (0.5) |
| Epistaxis | 2 (1.0) | 5 (2.4) | 4 (1.9) | 2 (1.0) |
| Nasal discomfort | 2 (1.0) | 2 (1.0) | 4 (1.9) | 0 (0.0) |
| MP 4004c | n=195 | n=189 | n=194 | n=200 |
| Dysgeusia (bitter taste) | 4 (2.1) | 1 (0.5) | 14 (7.2) | 1 (0.5) |
| Epistaxis | 3 (1.5) | 3 (1.6) | 3 (1.6) | 5 (2.5) |
| Headache | 5 (2.6) | 4 (2.1) | 4 (2.1) | 1 (0.5) |
| MP 4006c | n=451 | n=450 | n=449 | n=451 |
| Dysgeusia (bitter taste) | 21 (4.7) | 1 (0.2) | 23 (5.1) | 0 (0.0) |
| Epistaxis | 8 (1.8) | 5 (1.1) | 5 (1.1) | 8 (1.8) |
| Headache | 6 (1.3) | 6 (1.3) | 9 (2.0) | 2 (0.4) |
Notes:
Occurring in ≥1% of subjects in any treatment group. A subject with multiple adverse events was counted only once.
Adapted from Meltzer E, Ratner P, Bachert C, et al. Clinically relevant effect of a new intranasal therapy (MP29-02) in allergic rhinitis assessed by responder analysis. Int Arch Allergy Immunol. 2013;161(4):369–377. Copyright © 2013 Karger Publishers, Basel, Switzerland.13
Adapted from J Allergy Clin Immunol; 129(5). Carr W, Bernstein J, Lieberman P, et al. A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis. 1282–1289. Copyright 2012, with permission from Elsevier.10 MP-AzeFlu is composed of 137 µg AZE and 50 µg FP per spray. Studies: MP 4001, Texas mountain cedar, Winter; MP 4002, Spring; MP 4004, Fall; and MP 4006, Spring to Fall.
Abbreviations: FP, fluticasone propionate; AZE, azelastine HCl; PLA, placebo.