Table 1.
Baseline Patient Demographics and Disease Characteristics
| Total (N = 98) | |
|---|---|
| Age, yearsa | 43.8 ± 12.1 |
| Sex, n (%) | |
| Male | 54 (55.1) |
| Female | 44 (44.9) |
| Body mass index, kg/m2 a | 27.7 ± 4.8 |
| Smoking status | |
| Never smoked, n (%) | 68 (69.4) |
| Ex-smoker, n (%) | 30 (30.6) |
| Pack-yearsa | 4.8 ± 2.7 |
| Duration of asthma, yearsa | 20.2 ± 12.6 |
| Pre-bronchodilator FEV1 at screeninga,b | |
| Actual (mL) | 2518 ± 660 |
| % of predicted | 73.7 ± 8.6 |
| Pre-bronchodilator FEV1 at randomization (study baseline)a,c | |
| Actual (mL) | 2634 ± 773 |
| % of predicted | 76.7 ± 11.7 |
| Pre-bronchodilator FVC at randomization (study baseline)a,c | |
| Actual (mL) | 3964 ± 1027 |
| % of predicted | 97.0 ± 12.3 |
| ACQ-7 scorea,d | 2.5 ± 0.7 |
| ICS dose of stable maintenance treatment, μga,e | 661 ± 252 |
Treated set.
a
Values are mean ± standard deviation. bVisit 1 (screening), measured 10–15 min after inhalation of four puffs of salbutamol (100 μg per actuation). cVisit 2 (randomization), measured 10 min before inhalation of the first dose of study drug. dACQ-7 questions 1–6 were self-administered by patients and preceded any discussion with a healthcare professional. ACQ-7 question 7 was completed after pre-dose MasterScope® spirometry. eBudesonide or equivalent dose.
ACQ-7, seven-question Asthma Control Questionnaire; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroids.