Abstract
Introduction: Tiotropium Respimat® is well tolerated and efficacious as add-on therapy to maintenance low-dose ICS to high-dose ICS/LABA in adults with symptomatic asthma. Aims: We examined if these clinical benefits were consistent across groups classified as GINA Steps 2–5. Methods: Data were from 5 double-blind, placebo-controlled trials (patients 18–75 years) of the effect of tiotropium Respimat® on peak (within 3h post-dose FEV1(0-3h)) and trough (pre-dose) FEV1 response vs placebo. GINA Guidelines Step grouping was based on treatments in: GraziaTinA-asthma® (12wks, tiotropium 2.5μg, 5μg or placebo, as 2 puffs QD, added-on to ICS 200–400μg budesonide/equivalent), MezzoTinA-asthma® (2x 24wk trials, tiotropium, 2.5μg or 5μg, as 2 puffs QD, salmeterol 50μg bid or placebo added-on to ICS 400–800μg budesonide/equivalent) and PrimoTinA-asthma® (2x 48wk trials, tiotropium 5μg, as 2 puffs QD or placebo added-on to ICS ≥800μg budesonide/equivalent + LABA ± additional controller medications). Results: Baseline characteristics were balanced across treatment groups in each trial (N>3400). Tiotropium Respimat® provided improvements in peak and trough FEV1 across GINA Steps 2–5 vs placebo (Table 1); safety profiles were similar between tiotropium and placebo groups. Conclusion: Addition of tiotropium Respimat® to maintenance therapy in adult asthma patients provides significant and sustained improvements in lung function across GINA Steps 2–5.
Published Version
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