Title: A phase III randomized controlled trial of tiotropium add-on therapy in children with severe symptomatic asthma
Authors: Szefler, Stanley J. et al.
What You Need to Know:
Treatment with once-daily tiotropium Respimat 5mcg improved lung function when added to inhaled corticosteroid (ICS) therapy with other maintenance drugs in children with severe symptomatic asthma.
- Phase 3, 12-week, double-blind, placebo-controlled, parallel-group trial evaluated the safety and efficacy of once-daily tiotropium Respimat add-on therapy to high-dose ICS with ≥1 controller medications, or medium-dose ICS with ≥2 controller medications
- 401 patients aged 6–11 years enrolled
- Patients were randomized to once-daily tiotropium 5mcg (2 puffs of 2.5mcg) or 2.5mcg (2 puffs of 1.25mcg), or placebo (2 puffs) given through the Respimat device as add-on to background therapy
- Primary endpoint was peak forced expiratory volume in 1 second (FEV1) within 3 hours after dosing
- Key secondary endpoint was trough FEV1
- Tiotropium 5mcg improved the peak FEV1 within 3 hours after dosing (139mL, 95% CI: 75–203; P<0.001) vs. placebo
- Tiotropium 5mcg also improved the trough FEV1 (87mL, 95% CI: 19–154; P=0.01) vs. placebo
- Tiotropium 2.5mcg, however, did not improve the peak FEV1 within 3 hours after dosing (35mL, 95% CI: -28–99; P=0.27) or the trough FEV1 (18mL, 95% CI: -48–85; P=0.59) vs. placebo
- Safety and tolerability of tiotropium were comparable to placebo