BioMed Research International

Review Article

Managing Severe Asthma: A Role for the Long-Acting Muscarinic Antagonist Tiotropium

Table 1

Phase III trials investigating tiotropium in adults, adolescents, and children with severe asthma.


Trial(s)	ClinicalTrials.gov number(s)	Background treatment	Age, years	Trial duration, weeks	Week of primary endpoint reporting	Patients, n	Tiotropium 5 g versus placebo^a, mL	Tiotropium 2.5 g versus placebo^a, mL

PrimoTinA-asthma [25]	NCT00772538 NCT00776984	High-dose ICS + LABA	18–75	48	24	912	Peak FEV_1(0–3h) response: 86, P<0.05 154, P<0.001 Trough FEV₁ response: 88, P<0.01 111, P<0.001 ACQ response: –0.13, P=0.06 –0.20, P=0.003 ACQ responder rate:NR	N/A

PensieTinA-asthma [35]	NCT01277523	High-dose ICS + ≥1 controllers^b or Medium-dose ICS + ≥2 controllers^b	12–17	12	12	392	Peak FEV_1(0–3h) response: 90, P=0.104 Trough FEV₁ response: 54, P=0.361 ACQ-7 response: 0.036, P=NR ACQ-7 responder rate: NR, P=0.952	Peak FEV_1(0–3h) response: 111, P=0.046 Trough FEV₁ response: 115, P=0.051 ACQ-7 response: 0.058, P=NR ACQ-7 responder rate: NR, P=0.802

VivaTinA-asthma [34]	NCT01634152	High-dose ICS + ≥1 controllers^b or Medium-dose ICS + ≥2 controllers^b	6–11	12	12	400	Peak FEV_1(0–3h) response: 139, P<0.001 Trough FEV₁ response: 87, P=0.01 ACQ-IA response: –0.08, P=0.32 ACQ-IA responder rate: 80.8% vs. 76.9%, P=NR	Peak FEV_1(0–3h) response: 35, P=0.27 Trough FEV₁ response: 18, P=0.59 ACQ-IA response: 0.02, P=0.80 ACQ-IA responder rate: 79.4% vs. 76.9%, P=NR

^aAt week of primary endpoint reporting; ^be.g., LABA and/or leukotriene receptor antagonist and/or sustained-release theophylline. ACQ-7, seven-question Asthma Control Questionnaire; ACQ-IA, interviewer-administered version of the Asthma Control Questionnaire; FEV₁, forced expiratory volume in 1s; , FEV₁ within 3 hours after dose; LABA, long-acting β₂-agonsit; N/A, not applicable; NR, not reported; NS, not significant.