A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma.
We present results from the first phase III trial of once-daily tiotropium add-on to inhaled corticosteroids (ICS) plus one or more controller therapies in adolescents with severe symptomatic asthma.In this double-blind, parallel-group trial (NCT01277523), 392 patients aged 12-17 years were randomised to receive once-daily tiotropium 5 µg or 2.5 µg, or placebo, as an add-on to ICS plus other controller therapies over 12 weeks. The primary and key secondary end-points were change from baseline (response) in peak forced expiratory volume in 1 s (FEV1) within 3 h post-dosing (FEV1(0-3h)) and trough FEV1, respectively, after 12 weeks of treatment.Tiotropium 5 µg provided numerical improvements in peak FEV1(0-3h)response, compared with placebo (90 mL; p=0.104), and significant improvements were observed with tiotropium 2.5 µg (111 mL; p=0.046). Numerical improvements in trough FEV1response and asthma control were observed with both tiotropium doses, compared with placebo. The safety and tolerability of tiotropium were comparable with those of placebo.Once-daily tiotropium Respimat add-on to ICS plus one or more controller therapies in adolescents with severe symptomatic asthma was well tolerated. The primary end-point of efficacy was not met, although positive trends for improvements in lung function and asthma control were observed.
Klinik für Kinder- und Jugendmedizin, Kinderzentrum Bethel, Evangelisches Krankenhaus Bielefeld, Akademisches Lehrkrankenhaus der Universität Münster, Bielefeld, Germany eckard.hamelmann@evkb.de.
Eckard
E
Hamelmann
Bernstein Allergy Group, Cincinnati, OH, USA.|Department of Internal Medicine, Immunology, Allergy and Rheumatology, University of Cincinnati, Cincinnati, OH, USA.
Jonathan A
JA
Bernstein
Clinical Research of the Ozarks, Columbia, MO, USA.
Mark
M
Vandewalker
Boehringer Ingelheim, Sydney, Australia.
Petra
P
Moroni-Zentgraf
Clinical Operations, Medical Department, Boehringer Ingelheim Italia, Milan, Italy.
Daniela
D
Verri
Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany.
Anna
A
Unseld
Boehringer Ingelheim, Sydney, Australia.
Michael
M
Engel
U.O.C. di Pediatria, Dipartimento di Scienze Chirurgiche Odontostomatologiche e Materno Infantili, Policlinico "G. Rossi", Verona, Italy.
Attilio L
AL
Boner
D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology*; D002648:Child; D018680:Cholinergic Antagonists / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007391:International Cooperation; D008297:Male; D016016:Proportional Hazards Models; D000069447:Tiotropium Bromide / Q000008:administration & dosage*; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D018680:Cholinergic Antagonists; D000069447:Tiotropium Bromide