Table 3.
Adverse Events >5% and Greater Than EDS-placebo.
| Adverse Event | EDS-Placebo n = 82 | EDS-FLU 93 µg BID n = 81 | EDS-FLU 186 µg BID n = 80 | EDS-FU 372 µg BID n = 79 |
|---|---|---|---|---|
| Epistaxis,a no. (%) | 3 (3.7) | 3 (3.7) | 7 (8.8) | 6 (7.6) |
| Nasal mucosal disorder, no. (%) | 5 (6.1) | 11 (13.6) | 6 (7.5) | 6 (7.6) |
| Acute sinusitis, no. (%) | 4 (4.9) | 5 (6.2) | 6 (7.5) | 8 (10.1) |
| URTI, no. (%) | 7 (8.5) | 1 (1.2) | 4 (5.0) | 5 (6.3) |
| Nasal congestion, no. (%) | 4 (4.9) | 3 (3.7) | 2 (2.5) | 6 (7.6) |
| Nasal septum ulceration, no. (%) | 1 (1.2) | 5 (6.2) | 5 (6.3) | 4 (5.1) |
| Nasopharyngitis, no. (%) | 4 (4.9) | 3 (3.7) | 2 (2.5) | 4 (5.1) |
| Gastrointestinal disorders, no. (%) | 4 (4.9) | 1 (1.2) | 2 (2.5) | 4 (5.1) |
Abbreviations: BID, twice daily; EDS-FLU, exhalation delivery system with fluticasone; n, total of number of patients randomized/enrolled/treated; URTI, upper respiratory tract infection.
aIncludes spontaneous adverse reaction reports.