Eckard Hamelmann1, Eric D Bateman2, Christian Vogelberg3, Stanley J Szefler4, Mark Vandewalker5, Petra Moroni-Zentgraf6, Mandy Avis7, Anna Unseld8, Michael Engel6, Attilio L Boner9. 1. Klinik für Kinder- und Jugendmedizin, Kinderzentrum Bethel, Evangelisches Krankenhaus Bielefeld GmbH, Akademisches Lehrkrankenhaus der Universität Münster, Bielefeld, Germany. Electronic address: eckard.hamelmann@evkb.de. 2. Department of Medicine, University of Cape Town, Cape Town, South Africa. 3. University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany. 4. Department of Pediatrics, The Breathing Institute, Children's Hospital Colorado, Aurora, Colo. 5. Clinical Research of the Ozarks, Columbia, Mo. 6. TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany. 7. Boehringer Ingelheim bv, Alkmaar, The Netherlands. 8. Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany. 9. U.O. di Pediatria, S.S.O. Dipartimento Sperimentale di Pediatria, Policlinico "G. Rossi," Verona, Italy.
Abstract
BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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: Bhupendrasinh F Chauhan; Maya M Jeyaraman; Amrinder Singh Mann; Justin Lys; Ahmed M Abou-Setta; Ryan Zarychanski; Francine M Ducharme Journal: Cochrane Database Syst Rev Date: 2017-03-16
Authors: Diana M Sobieraj; William L Baker; Elaine Nguyen; Erin R Weeda; Craig I Coleman; C Michael White; Stephen C Lazarus; Kathryn V Blake; Jason E Lang Journal: JAMA Date: 2018-04-10 Impact factor: 56.272
Authors: Michelle M Cloutier; Alan P Baptist; Kathryn V Blake; Edward G Brooks; Tyra Bryant-Stephens; Emily DiMango; Anne E Dixon; Kurtis S Elward; Tina Hartert; Jerry A Krishnan; Robert F Lemanske; Daniel R Ouellette; Wilson D Pace; Michael Schatz; Neil S Skolnik; James W Stout; Stephen J Teach; Craig A Umscheid; Colin G Walsh Journal: J Allergy Clin Immunol Date: 2020-12 Impact factor: 10.793
Authors: Eckard Hamelmann; Jonathan A Bernstein; Mark Vandewalker; Petra Moroni-Zentgraf; Daniela Verri; Anna Unseld; Michael Engel; Attilio L Boner Journal: Eur Respir J Date: 2017-01-11 Impact factor: 16.671