The evolving role of tiotropium in asthma

Figures & data

Table 1 Key results of Phase III adult asthma studies with tiotropium Respimat^® 5μg

Study name	Treatment duration, weeks	N	Primary and key secondary endpoints	Difference from placebo
PrimoTinA-asthma^® Severe persistent asthma^Citation37	48	912	Peak FEV1, Week 24, mean (CI) mL	86 (20, 152) (P=0.01) Trial 1	Trial 2 154 (91, 217) (P<0.001)
			Trough FEV1, Week 24, mean (CI) mL	88 (27, 149) (P=0.01) Trial 1	Trial 2 111 (53, 169) (P<0.001)
			Time to first severe exacerbation	–0.2 (P=0.003) Trial 2 21% reduction in risk (HR 0.79; 95% CI: 0.62, 1.00; P=0.03)
			ACQ-7, adjusted mean score	NS
MezzoTinA-asthma^® Moderate persistent asthma^Citation38	24	2103	Peak FEV1, mean (CI) mL	198 (142, 253) (P<0.0001) Trial 1	(P<0.0001) Trial 2 169 (116, 222)
			Peak FVC, mean (CI) mL	102 (42, 162) (P=0.0008) Trial 1	(P=0.0031) Trial 2 89 (30, 147)
			ACQ-7, adjusted mean score	–0.12 (SD 0.04; P=0.0084)
GraziaTinA-asthma^® Mild persistent asthma^Citation39	12	465	Peak FEV1, Week 12 mean (CI) mL	128 (57, 199) (P<0.001)
			Trough FEV1, Week 12 mean (CI) mL	122 (49, 194) (P<0.001)
			ACQ-7 total score, Week 12	0.014 (–118, 0.146) (P=0.83)
CadenTinA-asthma^® Symptomatic asthma^Citation40	52	285	Long-term safety	Incidence of patients reporting AEs was similar across treatment groups
			Trough FEV1, Week 52 mean (CI) mL	112 (18, 207) (P=0.0203)

Abbreviations: ACQ-7, 7-question asthma control questionnaire; AE, adverse event; CI, confidence interval; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; HR, hazard ratio; ICS, inhaled corticosteroids; NS, not significant; SD, standard deviation.

Table 2 Phase III studies with tiotropium Respimat^® in children and adolescents with asthma

Study name	Patients (asthma severity and age)	Treatment duration, weeks	Baseline therapy	N (treatment group)	Study drug
RubaTinA-asthma^®41	Moderate persistent 12–17-year-olds	48	At least ICS	259	Tiotropium
PensieTinA-asthma^®42	Severe persistent 12–17-year-olds	12	ICS +≥1 controller	257	Respimat 2.5 and 5 μg
CanoTinA-asthma^®43	Moderate persistent 6–11-year-olds	48	At least ICS	270
VivaTinA-asthma^®^Citation44	Severe persistent 6–11-year-olds	12	At least ICS/+≥1 controller	262
NinoTinA-asthma^®^Citation45	Persistent 1–5-year-olds		At least ICS	67

Abbreviation: ICS, inhaled corticosteroids.

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