Tiotropium in chronic obstructive pulmonary disease – a review of clinical development

Respiratory Research

Table 1 Tiotropium reduces exacerbation and increases time to first exacerbation

Study	Comparator	Patients (N)	Study duration	Change from baseline in number of exacerbations	Change from baseline in patients with ≥ 1 exacerbation	Increase in time to first exacerbation
Casaburi 2002 [22]	Placebo	921	1 year	−20% (p = 0.045)	− 14% (p < 0.05)	p = 0.011
Vincken 2002 [34]	Ipratropium	535	1 year	−24% (p = 0.006)	−24% (p = 0.014)	p = 0.008
Brusasco 2003 [36]	Placebo	802^a	6 months	−28% (p < 0.05)	−18% (p > 0.05)	p ≤ 0.01
Niewoehner 2005 [37]	Placebo	1829	6 months	−19% (p = 0.031)	−14% (p = 0.037)	p = 0.028
Dusser 2006 [24]	Placebo	1010	1 year	−35% (p < 0.001)	− 17% (p < 0.01)	p < 0.001
Tashkin 2008 [26]	Placebo	5993	4 years	− 14% (p < 0.001)	−2% (p = 0.35)	p < 0.001
Tonnel 2008 [23]	Placebo	554	9 months	−43% (p = 0.0287)	− 16% (p = 0.1013)	p = 0.0081
Bateman 2010 [28]	Placebo	1990	1 year	p < 0.01**	−16% (p < 0.01)^b	p < 0.0001^b
Bateman 2010 [29]	Placebo	3991	48 weeks	−21% (p < 0.0001)	− 18% (p < 0.0001)	p < 0.0001
Vogelmeier 2011 [39]	Salmeterol	7376	1 year	−11% (p = 0.002)^c	−11% (p < 0.001)^c	p < 0.001

**p < 0.01 for tiotropium 5 μg dose and p < 0.001 for tiotropium 10 μg dose
^aThis number does not include the patients in the salmeterol group. ^bFor both tiotropium 5-μg and 10-μg doses. ^cRefers to moderate or severe exacerbations

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