Impact of frequency of COPD exacerbations on pulmonary function, health status and clinical outcomes

Figures & data

Table 1 Mean (SE) changes in FEV₁ (mL) in the tiotropium and placebo groups over 1 year according to exacerbation frequency

	Tiotropium (n = 518)		Placebo (n = 328)
Exacerbation frequency	N	Δ FEV1 (mL)	N	Δ FEV1 (mL)
0	327	+134 (12)	179	−36 (16)*
1	111	+115 (20)	92	−32 (22)*
2	44	+19 (32)	34	−50 (37)
>2	36	+78 (36)	23	−59 (44)*

* P < 0.05 tiotropium vs placebo.

Table 2 Mean (SE) changes in the St. Georges Respiratory Questionnaire total scores in the tiotropium and placebo groups over 1 year according to exacerbation frequency

	Tiotropium (n = 516)		Placebo (n = 324)
Exacerbation frequency	N	Total score	N	Total score
0	326	−4.0 (0.7)	175	−1.5 (0.9)**
1	111	−2.7 (1.1)	92	0.9 (1.2)**
2	44	−1.3 (1.8)	34	2.6 (2.0)
>2	35	−3.4 (2.0)	23	5.3 (2.5)**

** P < 0.05 tiotropium vs placebo.

Table 3 Number of exacerbations per patient year according to treatment group and end-of-treatment transition dyspnea index (TDI) focal score, and change from baseline in St. Georges Respiratory Questionnaire (SGRQ 0total score)

	Tiotropium				Placebo
	N treated	No. of exacerbations	Patient years	Rate	N treated	No. of exacerbations	Patient years	Rate
ΔTDI
Focal score
≤−1	81	88	63.0	1.40	80	91	60.5	1.50
0	193	108	156.5	0.69	152	106	122.5	0.87
≥1	233	123	198.5	0.62	93	49	79.1	0.62
ΔSGRQ
Total score
≥4	118	82	96.6	0.85	113	102	89.4	1.14
≥0, <4	65	39	51.2	0.76	48	33	37.8	0.87
> −4, <0	79	51	63.6	0.80	65	58	53.4	1.09
≤ −4	254	148	214.1	0.69	98	54	81.1	0.67