Table 2.
Baseline disease characteristics and control measures by FAO category (LLN definition).
| Study I (mild to moderate) |
Study II (moderate to severe) |
|||
|---|---|---|---|---|
| FAO+ (n =116) | FAO− (n =371) | FAO+ (n =226) | FAO− (n =333) | |
| FEV1a | ||||
| Liters | 2.31 (0.66) | 2.34 (0.63) | 2.15 (0.67) | 2.28 (0.63) |
| % Predicted (NHANES III) [9] | 65.5 (10.7) | 74.0 (12.9) | 63.6 (11.15) | 70.7 (10.6) |
| FVCa | ||||
| Liters | 3.85 (1.01) | 3.30 (0.92) | 3.49 (1.06) | 3.20 (0.90) |
| % Predicted (NHANES III) [9] | 89.2 (12.1) | 85.0 (13.2) | 83.5 (13.5) | 80.4 (12.3) |
| FEF25–75%a | ||||
| Liters/s | 1.33 (0.52) | 1.75 (0.64) | 1.22 (0.51) | 1.70 (0.66) |
| % Predicted (NHANES III) [9] | 36.5 (10.3) | 54.0 (18.3) | 35.7 (10.05) | 52.1 (15.4) |
| FEV1/FVCa | 0.61 (0.06) | 0.73 (0.08) | 0.63 (0.06) | 0.73 (0.07) |
| Rescue medication use,b inhalations/day | 3.28 (3.41) | 2.54 (2.35) | 2.81 (2.51) | 2.20 (2.20) |
| Asthma symptom scoreb (scale 0–3)c | 1.13 (0.45) | 1.08 (0.45) | 1.02 (0.45) | 1.05 (0.45) |
| Awakening-free nights,b % | 70.7 (26.4) | 70.6 (24.1) | 73.0 (23.2) | 76.4 (20.4) |
Data presented as mean (SD) unless otherwise noted. BMI, body mass index; FAO, fixed airflow obstruction; FEF, forced expiratory flow; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; LLN, lower limit of normal; NHANES III, third National Health and Nutrition Examination Survey; pMDI, pressurized metered-dose inhaler.
Baseline defined as value at day of randomization.
Baseline defined as the mean of values during the run-in period on placebo (study I) or budesonide pMDI 160 μg twice daily (study II) and as-needed albuterol 90 μg per inhalation (both studies) [12,13].
Scores measured on a scale of 0–3 (where 0 = no symptoms and 3 = severe symptoms).