Table 3.
Adverse Events Using SITT and SIDT
| Adverse Events | SITT, n = 52 | SIDT, n = 49 | P-value |
|---|---|---|---|
| Any adverse events | 15 (28.9) | 12 (24.5) | 0.7 |
| Serious adverse events | 0 (0) | 0 (0) | 1.0 |
| Adverse events leading to discontinuation | 0 (0) | 0 (0) | 1.0 |
| Adverse events leading to death | 0 (0) | 0 (0) | 1.0 |
| Dysphonia | 5 (9.6) | 7 (14.3) | 0.5 |
| Transient coughing after administration | 4 (7.7) | 2 (4.1) | 0.7 |
| Dry mouth | 5 (9.6) | 0 (0) | 0.1 |
| Respiratory tract infections | 2 (3.9) | 1 (2.0) | 1.0 |
| Dyspepsia | 2 (3.9) | 0 (0) | 0.5 |
| Oral candidiasis | 1 (1.9) | 0 (0) | 1.0 |
| Diarrhea | 0 (0) | 1 (2.0) | 0.5 |
| Leg muscle cramps | 0 (0) | 1 (2.0) | 0.5 |
Note: No patients had episodes of pneumonia.
Abbreviations: SIDT; single-inhaler dual therapy, SITT; single-inhaler triple therapy.