Efficacy of Once-Daily Tiotropium Respimat® on Lung Function and Asthma Control in Adults with Asthma at GINA Steps 2–5
Monday, March 5, 2018
South Hall A2 (Convention Center)
Roland Buhl, MD, J Mark FitzGerald, FRCPC, Eli O. Meltzer, MD, Alberto de la Hoz, Ralf Sigmund, Huib AM Kerstjens, MD, Eugene R. Bleecker, MD
RATIONALE: Tiotropium Respimat® is a well-tolerated and efficacious add-on treatment in adults with symptomatic asthma. We examined whether clinical benefits are consistent across asthma severity groups (GINA Steps 2–5).

METHODS: Post hoc analyses were performed across five double-blind, placebo-controlled trials (GraziaTinA-asthma®, MezzoTinA-asthma®, PrimoTinA-asthma®; patients aged 18–75 years) to determine the effect of tiotropium 5μg or 2.5μg versus placebo on peak FEV1 within 3 hours’ post-dose (FEV1(0–3h)), trough FEV1 and Asthma Control Questionnaire (ACQ-7) responder rates across GINA Steps 2–5. GINA Step grouping was based on patients’ treatment regimen.

RESULTS: Baseline characteristics of included patients (N=2926) were balanced between treatment arms. Tiotropium showed consistent improvements in peak and trough FEV1 levels across GINA Steps. Placebo-corrected peak FEV1(0–3h) improvements after tiotropium 5μg and 2.5μg were: Step 2 (Week 8), 135mL (95% CI: 84, 187) and 155mL (103, 206); Step 3 (Week 24), 187mL (139, 235) and 235mL (187, 283); Step 4 (Week 24), 111mL (63, 159) and 181mL (35, 326); Step 5 (Week 24; 5μg only), 164mL (5, 323). Improvement trends in ACQ-7 responder rates were observed with tiotropium 5μg and 2.5μg; odds ratios vs placebo were: Step 3, 1.17 (0.85, 1.61) and 1.26 (0.91, 1.74); Step 4, 1.36 (1.03, 1.78) and 2.12 (0.98, 4.79); Step 5 (5μg), 1.85 (0.68, 5.06). Safety profiles were similar between treatment and placebo.

CONCLUSIONS: Addition of tiotropium Respimat® to maintenance therapy improves lung function and may improve asthma control in adult patients with symptomatic asthma across GINA Steps 2–5.