Roxithromycin + Doxycycline (n = 101) | Roxithromycin (n = 97) | Placebo (n = 94) | ||||
---|---|---|---|---|---|---|
Through 48-week period post treatment | ||||||
Number of exacerbations | N | % of overall exacerbations | N | % of overall exacerbations | N | % of overall exacerbations |
Overall | 263 | 302 | 261 | |||
Moderate and severe | 217 | 82.51 % | 221 | 73.18 % | 193 | 73.94 % |
Event rate/patient year | ||||||
Overall | 3.43 | 3.67 | 3.38 | |||
Moderate and severe | 2.83 | aP = 0.352 | 2.69 | aP = 0.5832 | 2.50 | |
During 12-week active treatment period | ||||||
Number of exacerbations | N | % of overall exacerbations | N | % of overall exacerbations | N | % of overall exacerbations |
Overall | 52 | 51 | 67 | |||
Moderate and severe | 37 | 71.15 % | 39 | 76.47 % | 48 | 71.64 % |
Event rate/patient year | ||||||
Overall | 2.31 | 2.27 | 3.14 | |||
Moderate and severe | 1.64 | aP = 0.1709 | 1.74 | aP = 0.2545 | 2.25 | |
During the first 24-week period post treatment | ||||||
Number of exacerbations | N | % of overall exacerbations | N | % of overall exacerbations | N | % of overall exacerbations |
Overall | 146 | 150 | 141 | |||
Moderate and severe | 117 | 80.13 % | 108 | 72 % | 103 | 73.05 % |
Event rate/patient year | ||||||
Overall | 3.72 | 3.57 | 3.55 | |||
Moderate and severe | 2.98 | aP = 0.3864 | 2.57 | aP = 0.9577 | 2.59 | |
During the last 24 week period post treatment | ||||||
Number of exacerbations | N | % of overall exacerbations | N | % of overall exacerbations | N | % of overall exacerbations |
Overall | 117 | 152 | 120 | |||
Moderate and severe | 100 | 85.47 % | 113 | 74.34 % | 90 | 75 % |
Event rate/patient year | ||||||
Overall | 3.12 | 3.78 | 3.20 | |||
Moderate and severe | 2.67 | aP = 0.5426 | 2.81 | aP = 0.3496 | 2.40 |