title: Tiotropium add-on therapy in adolescents with moderate asthma: A 1-year randomized controlled trial.
abstract: Results from phase III clinical trials in adults and phase II clinical trials in children and adolescents demonstrate that tiotropium is an effective treatment when added to inhaled corticosteroid (ICS) maintenance therapy.
  
  
  
  We sought to assess the efficacy and safety of once-daily tiotropium Respimat added to ICSs with or without a leukotriene receptor antagonist in a phase III trial in adolescent patients with moderate symptomatic asthma.
  
  
  
  In this 48-week, double-blind, placebo-controlled, parallel-group study, 398 patients aged 12 to 17 years were randomized to receive 5 μg (2 puffs of 2.5 μg) or 2.5 μg (2 puffs of 1.25 μg) of once-daily tiotropium or placebo (2 puffs) administered through the Respimat device every evening, each as add-on treatment to ICS background therapy, with or without a leukotriene receptor antagonist; long-acting β2-agonist therapy was not permitted during the study.
  
  
  
  Improvement in peak FEV1 within 3 hours after dosing at 24 weeks (primary end point) was statistically significant with both tiotropium doses compared with placebo: 5 μg of tiotropium, 174 mL (95% CI, 76-272 mL); 2.5 μg of tiotropium, 134 mL (95% CI, 34-234 mL). Significant improvements in trough FEV1 at week 24 (a secondary end point) were observed with the 5-μg dose only. Trends for improvement in asthma control and health-related quality of life over the 48-week treatment period were observed.
  
  
  
  Once-daily tiotropium significantly improved lung function and was safe and well tolerated when added to at least ICS maintenance therapy in adolescent patients with moderate symptomatic asthma. Larger responses were observed with the 5-μg tiotropium dose.
authors.affiliation: Klinik für Kinder- und Jugendmedizin, Kinderzentrum Bethel, Evangelisches Krankenhaus Bielefeld GmbH, Akademisches Lehrkrankenhaus der Universität Münster, Bielefeld, Germany. Electronic address: eckard.hamelmann@evkb.de.
authors.forename: Eckard
authors.initials: E
authors.lastname: Hamelmann
authors.affiliation: Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Bateman
authors.affiliation: University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Vogelberg
authors.affiliation: Department of Pediatrics, The Breathing Institute, Children's Hospital Colorado, Aurora, Colo.
authors.forename: Stanley J
authors.initials: SJ
authors.lastname: Szefler
authors.affiliation: Clinical Research of the Ozarks, Columbia, Mo.
authors.forename: Mark
authors.initials: M
authors.lastname: Vandewalker
authors.affiliation: TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
authors.forename: Petra
authors.initials: P
authors.lastname: Moroni-Zentgraf
authors.affiliation: Boehringer Ingelheim bv, Alkmaar, The Netherlands.
authors.forename: Mandy
authors.initials: M
authors.lastname: Avis
authors.affiliation: Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
authors.forename: Anna
authors.initials: A
authors.lastname: Unseld
authors.affiliation: TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Engel
authors.affiliation: U.O. di Pediatria, S.S.O. Dipartimento Sperimentale di Pediatria, Policlinico "G. Rossi," Verona, Italy.
authors.forename: Attilio L
authors.initials: AL
authors.lastname: Boner
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D019540:Area Under Curve; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy*; D002648:Child; D004359:Drug Therapy, Combination; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D012307:Risk Factors; D012720:Severity of Illness Index; D000069447:Tiotropium Bromide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D000069447:Tiotropium Bromide
keywords: Adolescent; FEV(1); Respimat; anticholinergic drug; asthma; asthma control; efficacy; lung function; safety; tiotropium