Tiotropium in asthmatic adolescents symptomatic despite inhaled corticosteroids: A randomised dose-ranging study - 11/09/14
Summary |
Introduction |
Tiotropium, a once-daily long-acting anticholinergic agent, has been shown to be an efficacious and safe add-on treatment for adults with symptomatic asthma, despite treatment with inhaled corticosteroids (ICS). A large proportion of asthmatic adolescents have symptomatic disease despite a wide range of therapeutic options. We investigated the efficacy and safety of three doses of tiotropium, administered in the evening (via Respimat® SoftMist™ inhaler), versus placebo in asthmatic adolescents symptomatic despite ICS treatment.
Methods |
This randomised, double-blind, placebo-controlled, incomplete crossover study evaluated once-daily tiotropium 5 μg, 2.5 μg and 1.25 μg versus placebo in three 4-week treatment periods. Primary efficacy end point was change in peak forced expiratory volume in 1 s within 3 h post-dose from baseline (peak FEV1(0–3h)).
Results |
From 139 enrolled patients, 105 were randomised to receive one of four treatment sequences. Peak FEV1(0–3h) response for tiotropium 5 μg was significantly greater versus placebo (p = 0.0043). Trough FEV1 responses were significantly greater for tiotropium 5 μg (p < 0.00001) and 1.25 μg (p = 0.0134) versus placebo, but not for 2.5 μg (p = 0.0975), while FEV1 area under the curve(0–3h) responses were significant for all doses (p = 0.00001–0.0398). Overall incidence of adverse events was balanced across treatment groups, with no dose-dependent observations. The majority of adverse events were mild to moderate in intensity.
Conclusion |
This first study of tiotropium in adolescents with symptomatic asthma demonstrates that tiotropium is well tolerated and efficacious as add-on to maintenance treatment with ICS.
ClinicalTrials.gov identifier; NCT01122680.
Le texte complet de cet article est disponible en PDF.Keywords : Tiotropium, Anticholinergic, Bronchodilator, Asthma, Adolescents, Inhaled corticosteroids
Plan
Vol 108 - N° 9
P. 1268-1276 - septembre 2014 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?