Table 1. Clinical demographic and clinical characteristics of the study subjects in the full analysis set population.
| Characteristic | p-MDI (n = 35) | DPI (n = 33) | P value | |
|---|---|---|---|---|
| Age (yr) | 65.97 ± 7.66 | 65.03 ± 6.51 | 0.588 | |
| Sex (female) | 19 (54.3) | 19 (57.6) | 0.977 | |
| Body mass index (kg/m2) | 24.95 ± 3.67 | 25.46 ± 4.55 | 0.618 | |
| Age of asthma diagnosis (yr) | 53.6 ± 13.0 | 50.4 ± 10.5 | 0.489 | |
| Smoking status | ||||
| Current smoker | 4 (11.4) | 2 (6.1) | 0.443 | |
| Ex-smoker | 14 (40.0) | 8 (24.2) | 0.168 | |
| Never smoked | 17 (48.6) | 23 (69.7) | ||
| Asthma control status | 0.242 | |||
| Uncontrolled | 3 (8.6) | 6 (18.2) | ||
| Partially controlled | 32 (91.4) | 27 (81.8) | ||
| Controlled | 0 (0.0) | 0 (0.0) | ||
| Asthma duration | 0.622 | |||
| Over 15 years | 17 (48.6) | 18 (54.5) | ||
| Less than 15 years | 18 (51.4) | 15 (45.5) | ||
| Inhaler before study entry | 0.902 | |||
| Low dose ICS-LABA | 7 (20.0) | 7 (21.2) | ||
| Medium/High dose ICS-LABA | 28 (80.0) | 26 (78.8) | ||
| Same device used | 4 (11.4) | 7 (21.2) | 0.284 | |
| FEV1 (%) | 87.1 ± 21.2 | 88.2 ± 23.4 | 0.893 | |
| MMEF (%) | 77.1 ± 39.7 | 71.7 ± 36.6 | 0.572 | |
| FVC (%) | 83.7 ± 16.1 | 86.1 ± 19.0 | 0.611 | |
| RV (L) | 2.48 ± 0.45 | 2.40 ± 0.54 | 0.528 | |
| RV/TLC (%) | 45.7 ± 8.0 | 45.4 ± 7.2 | 0.889 | |
| FeNO (ppb) | 31.55 ± 22.7 | 24.4 ± 13.7 | 0.126 | |
| ACT score | 20.6 ± 4.5 | 21.4 ± 3.2 | 0.586 | |
The full analysis set population included all the patients who underwent randomization. P values were obtained from the Mann-Whitney U test for continuous variables and the χ2 test for categorical variables. Plus-minus values are mean ± standard deviation.
p-MDI, pressurized metered-dose inhalers; DPI, dry powder inhalers; ICS, inhaled corticosteroid; LABA, long-acting β2 agonist; FEV1, forced expiratory volume in 1 second; MMEF, maximal mid-expiratory flow; FVC, forced vital capacity; RV, residual volume; RV/TLC, residual volume/total lung capacity ratio; FeNO, fractional exhaled nitric oxide; ACT, asthma control test.