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

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

卷:140

Article

Szefler, Stanley J.^1,2  Murphy, Kevin³  Harper, Thomas, III⁴  Boner, Attilio⁵  Laki, Istvan⁶  Engel, Michael⁷  El Azzi, Georges⁷  Moroni-Zentgraf, Petra⁸  Finnigan, Helen⁹  Hamelmann, Eckard^10,11 

[1] Childrens Hosp Colorado, Dept Pediat, 13123 E 16th Ave, Aurora, CO 80045 USA

[2] Univ Colorado, Sch Med, Breathing Inst, 13123 E 16th Ave, Aurora, CO 80045 USA

[3] Boys Town Natl Res Hosp, Boys Town, NE USA

[4] Charleston Allergy & Asthma, Charleston, SC USA

[5] Policlin G Rossi, Dipartimento Sperimentale Pediat, UO Pediat, Verona, Italy

[6] Dept Paediat Pulmonol, Torokbalint, Hungary

[7] Boehringer Ingelheim Pharma GmbH & Co KG, Therapeut Area Resp Dis, Ingelheim, Germany

[8] Boehringer Ingelheim GmbH & Co KG, Sydney, NSW, Australia

[9] Boehringer Ingelheim GmbH & Co KG, Biostat & Data Sci, Bracknell, Berks, England

[10] Evangel Krankenhaus Bielefeld, Bielefeld, Germany

[11] Ruhr Univ, Allergy Ctr, Bochum, Germany

关键词: Anticholinergic drug;    asthma;    asthma control;    children;    efficacy;    FEV1;    lung function;    Respimat;    safety;    tiotropium;   

DOI  :  10.1016/j.jaci.2017.01.014

来源: Elsevier

【 摘 要 】

Background: Studies in adults and adolescents have demonstrated that tiotropium is efficacious as an add-on therapy to inhaled corticosteroids (ICSs) with or without other maintenance therapies in patients with moderate or severe symptomatic asthma. Objective: We sought to 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. Methods: In this 12-week, double-blind, placebo-controlled, parallel-group trial, 401 participants aged 6 to 11 years were randomized to receive once-daily tiotropium 5 mu g (2 puffs of 2.5 mu g) or 2.5 mu g (2 puffs of 1.25 mu g), or placebo (2 puffs), administered through the Respimat device as add-on to background therapy. Results: Compared with placebo, tiotropium 5 mg, but not 2.5 mg, add-on therapy improved the primary end point, peak FEV1 within 3 hours after dosing (5 mu g, 139 mL [95% CI, 75-203; P < .001]; 2.5 mu g, 35 mL [95% CI, -28 to 99; P 5.27]), and the key secondary end point, trough FEV1 (5 mu g, 87 mL [95% CI, 19-154; P = .01]; 2.5 mu g, 18 mL [95% CI, -48 to 85; P = .59]). The safety and tolerability of tiotropium were comparable with those of placebo. Conclusions: Once-daily tiotropium Respimat 5 mu g improved lung function and was well tolerated as add-on therapy to ICS with other maintenance therapies in children with severe symptomatic asthma.

【 授权许可】

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