Tiotropium for the Treatment of Asthma: Patient Selection and Perspectives

Table 1

Results of Phase III adult asthma studies with tiotropium Respimat 5 µg.

Study name	Treatment duration (weeks)	N	Primary and key secondary endpoints	Difference from placebo
PrimoTinA-asthma severe persistent asthma [21]	48	912	Peak FEV1, week 24, mean (CI) mL	86 (20, 152) () trial 1	154 (91, 217) () trial 2
			Trough FEV1, week 24, mean (CI) mL	88 (27, 149) mL () trial 1	111 (53, 169) mL () trial 2
			Time to first severe exacerbation	21% reduction in risk (HR 0.79; 95% CI: 0.62, 1.00; )
			ACQ-7, adjusted mean score	NS	−0.2 () trial 2
MezzoTinA-asthma moderate persistent asthma [22]	24	2103	Peak FEV1, mean (CI) mL	198 (142, 253) mL () trial 1	169 (116, 222) mL () trial 2
			Peak FVC, mean (CI) mL	102 (42, 162) mL () trial 1	89 (30, 147) mL () trial 2
			ACQ-7, adjusted mean score	−0.12 (SD 0.04; )
GraziaTinA-asthma mild persistent asthma [23]	12	465	Peak FEV1, week 12, mean (CI) mL	128 mL (95% CI: 57, 199; )
			Trough FEV1, week 12, mean (CI) mL	122 mL (95% CI: 49, 194; )
			ACQ-7 total score, week 12	0.014 (95% CI: −118, 0.146; )

ACQ-7, 7-question Asthma Control Questionnaire; CI, confidence interval; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; HR, hazard ratio; ICSs, inhaled corticosteroids; NS, not significant; SD, standard deviation. Table reproduced from E. R. McIvor and R. A. McIvor [20], under the Creative Commons Attribution License/public domain.