Table 4. Total experiences of local adverse events and asthma exacerbation during 12 weeks of treatment.
| Numbers of local adverse events | MON-400BUD | 800BUD | P | ||
|---|---|---|---|---|---|
| # of events | # of patients | # of events | # of patients | ||
| Total local adverse events | 36 | 14 | 45 | 17 | 0.171 |
| Oral thrush | 0 | 0 | 0 | 0 | 1.000 |
| Sore throat | 11 | 10 | 22 | 14 | 0.045 |
| Voice change | 6 | 6 | 6 | 5 | 1.000 |
| Laryngeal discomfort | 13 | 9 | 14 | 10 | 1.000 |
| Paroxysmal cough immediately after inhalation | 6 | 3 | 3 | 2 | 0.493 |
| Total asthma exacerbation | 14 | 7 | 28 | 13 | 0.016 |
| Requiring oral corticosteroids | 9 | 7 | 20 | 12 | 0.036 |
| Unscheduled OPD visit | 3 | 1 | 6 | 2 | 0.493 |
| ED visit | 2 | 2 | 2 | 2 | 1.000 |
Fisher's exact test was used to compare numbers of events between two groups.
MON-400BUD, combination therapy consisting of montelukast and low-dose inhaled budesonide; 800BUD, monotherapy consisting of a medium dose of inhaled budesonide; #, number; OPD, outpatient department; ED, emergency department.