Stanley J Szefler1, Kevin Murphy2, Thomas Harper3, Attilio Boner4, István Laki5, Michael Engel6, Georges El Azzi6, Petra Moroni-Zentgraf7, Helen Finnigan8, Eckard Hamelmann9. 1. Department of Pediatrics, Children's Hospital of Colorado and the University of Colorado School of Medicine, The Breathing Institute, Aurora, Colo. Electronic address: Stanley.Szefler@childrenscolorado.org. 2. Boys Town National Research Hospital, Boys Town, Neb. 3. Charleston Allergy and Asthma, Charleston, SC. 4. U.O. di Pediatria, Dipartimento Sperimentale di Pediatria, Policlinico "G. Rossi," Verona, Italy. 5. Department of Paediatric Pulmonology, Törökbálint, Hungary. 6. Therapeutic Area Respiratory Diseases, Boehringer Ingelheim Pharma, Ingelheim am Rhein, Germany. 7. Boehringer Ingelheim, Sydney, Australia. 8. Biostatistics and Data Sciences, Boehringer Ingelheim, Bracknell, United Kingdom. 9. Evangelisches Krankenhaus Bielefeld, Bielefeld, Germany; Allergy Center of the Ruhr University, Bochum, Germany.
Abstract
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 μg (2 puffs of 2.5 μg) or 2.5 μg (2 puffs of 1.25 μg), or placebo (2 puffs), administered through the Respimat device as add-on to background therapy. RESULTS: Compared with placebo, tiotropium 5 μg, but not 2.5 μg, add-on therapy improved the primary end point, peak FEV1 within 3 hours after dosing (5 μg, 139 mL [95% CI, 75-203; P < .001]; 2.5 μg, 35 mL [95% CI, -28 to 99; P = .27]), and the key secondary end point, trough FEV1 (5 μg, 87 mL [95% CI, 19-154; P = .01]; 2.5 μg, 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 μgimproved lung function and was well tolerated as add-on therapy to ICS with other maintenance therapies in children with severe symptomatic asthma.
RCT Entities:
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 μg (2 puffs of 2.5 μg) or 2.5 μg (2 puffs of 1.25 μg), or placebo (2 puffs), administered through the Respimat device as add-on to background therapy. RESULTS: Compared with placebo, tiotropium 5 μg, but not 2.5 μg, add-on therapy improved the primary end point, peak FEV1 within 3 hours after dosing (5 μg, 139 mL [95% CI, 75-203; P < .001]; 2.5 μg, 35 mL [95% CI, -28 to 99; P = .27]), and the key secondary end point, trough FEV1 (5 μg, 87 mL [95% CI, 19-154; P = .01]; 2.5 μg, 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 μg improved lung function and was well tolerated as add-on therapy to ICS with other maintenance therapies in children with severe symptomatic asthma.
Authors: Katie M Lebold; Matthew G Drake; Lauren B Hales-Beck; Allison D Fryer; David B Jacoby Journal: Am J Respir Cell Mol Biol Date: 2020-04 Impact factor: 6.914