Table 3.
Number of patients with at least one exacerbation and dropouts by disease severity in the 12-month data set (12-month data set; Calverley et al, and Szafranski et al studies only)9,12
| Patients, n (%) | B/F
|
|||
|---|---|---|---|---|
| Moderate (n=106) |
Severe (n=266) |
Very severe (n=84) |
Alla (n=456) |
|
| COPD exacerbation | 30 (28.3) | 96 (36.1) | 42 (50.0) | 168 (36.8) |
| Dropout | 22 (20.8) | 80 (30.1) | 27 (32.1) | 129 (28.3) |
|
| ||||
|
Placebo
|
||||
|
Moderate (n=108) |
Severe (n=275) |
Very severe (n=71) |
Alla (n=454) |
|
|
| ||||
| COPD exacerbation | 43 (39.8) | 121 (44.0) | 31 (43.7) | 195 (43.0) |
| Dropout | 41 (38.0) | 115 (41.8) | 35 (49.3) | 191 (42.1) |
Notes:
a
The 12-month data set includes data from the two 12-month studies.9,12 ITT population includes only patients analyzed for exacerbations (n=910). Moderate COPD was defined as post-bronchodilator FEV1 80%–50% predicted, severe COPD as post-bronchodilator FEV1 50%–30% predicted, and very severe COPD as post-bronchodilator FEV1 <30% predicted.
Abbreviations: B/F, budesonide/formoterol; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s.