A phase III randomized controlled trial of tiotropium add-on therapy in children with severe symptomatic asthma

Publication date: Available online 9 February 2017
Source:Journal of Allergy and Clinical Immunology
Author(s): Stanley J. Szefler, Kevin Murphy, Thomas Harper, Attilio Boner, István Laki, Michael Engel, Georges El Azzi, Petra Moroni-Zentgraf, Helen Finnigan, Eckard Hamelmann
BackgroundStudies in adults and adolescents have demonstrated that tiotropium is efficacious as an add-on therapy to inhaled corticosteroids (ICS) with or without other maintenance therapies in patients with moderate or severe symptomatic asthma.ObjectiveTo assess the efficacy and safety of once-daily tiotropium Respimat add-on therapy to high-dose ICS with 1 or more controller medications, or medium-dose ICS with 2 or more controller medications, in the first phase III trial of tiotropium in children with severe symptomatic asthma.MethodsIn this 12-week, double-blind, placebo-controlled, parallel-group trial, 401 participants aged 6-11 years were randomized to receive once-daily tiotropium 5 μg (2 puffs of 2.5 μg) or 2.5 μg (2 puffs of 1.25 μg), or placebo (2 puffs), administered through the Respimat device as add-on to background therapy.ResultsCompared with placebo, tiotropium 5 μg add-on therapy, but not 2.5 μg, improved the primary endpoint, peak forced expiratory volume in 1 second (FEV1) within 3 hours after dosing (5 μg, 139 mL [95% CI, 75-203; P < 0.001]; 2.5 μg, 35 mL [95% CI, −28-99; P = 0.27]), and the key secondary endpoint, trough FEV1 (5 μg, 87 mL [95% CI, 19-154; P = 0.01]; 2.5 μg, 18 mL [95% CI, −48-85; P = 0.59]). The safety and tolerability of tiotropium were comparable with those of placebo.ConclusionOnce-daily tiotropium Respimat 5 μg improved lung function and was well tolerated as add-on therapy to ICS with other maintenance therapies in children with severe symptomatic asthma.

Teaser

Once-daily tiotropium Respimat 5 μg as add-on therapy to ICS with other maintenance therapy has been shown for the first time to provide improved lung function in children with severe symptomatic asthma.


http://ift.tt/2ly0vS3