Table 2.
Number of patients with at least one exacerbation and dropouts by disease severity in the 3-month data set (Calverley et al, Szafranski et al, and CLIMB studies)9,10,12
| Patients, n (%) | B/F
|
|||
|---|---|---|---|---|
| Moderate (n=196) |
Severe (n=469) |
Very severe (n=117) |
Alla (n=782) |
|
| COPD exacerbation | 24 (12.2) | 60 (12.8) | 27 (23.1) | 111 (14.2) |
| Dropout | 20 (10.2) | 47 (10.0) | 14 (12.0) | 81 (10.4) |
|
| ||||
|
Placebo
|
||||
|
Moderate (n=178) |
Severe (n=492) |
Very severe (n=112) |
Alla (n=782) |
|
|
| ||||
| COPD exacerbation | 44 (24.7) | 122 (24.8) | 30 (26.8) | 196 (25.1) |
| Dropout | 28 (15.7) | 81 (16.5) | 25 (22.3) | 134 (17.1) |
Notes:
a
The 3-month data set includes 3-month data from the two 12-month studies9,12 as well as that from the 3-month study.10 ITT population includes only patients analyzed for exacerbations (n=1,564). 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.