Table 3.

Moderate and severe exacerbations of COPD by treatment groups

	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

Number and event rate (per patient year) of moderate and severe exacerbations in each treatment group. ^aP values shown are from comparison of event rate with the placebo group