Tiotropium Respimat® Versus HandiHaler®: Comparison of Bronchodilator Efficacy of Various Doses in Clinical Trials

• Published in: Advances in therapy 2016-05, Vol.33 (5), p.786-793
• Main Authors: Calverley, Peter M. A., Könen-Bergmann, Michael, Richard, Frank, Bell, Susan, Hohlfeld, Jens M.
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Aged; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Bronchodilator Agents - pharmacokinetics; Cardiology; Dose-Response Relationship, Drug; Drug Monitoring; Endocrinology; Female; Forced Expiratory Volume - drug effects; Health technology assessment; Humans; Internal Medicine; Male; Medicine; Medicine & Public Health; Middle Aged; Muscarinic Antagonists - therapeutic use; Oncology; Original Research; Pharmacology/Toxicology; Pulmonary Disease, Chronic Obstructive - drug therapy; Rheumatology; Tiotropium Bromide - administration & dosage; Tiotropium Bromide - adverse effects; Tiotropium Bromide - pharmacokinetics; Treatment Outcome
• ISSN: 0741-238X; 1865-8652
• DOI: 10.1007/s12325-016-0322-9

Introduction The long-acting muscarinic antagonist tiotropium bromide is approved in many countries as maintenance therapy for chronic obstructive pulmonary disease (COPD). Tiotropium is available as a dry-powder formulation delivered via HandiHaler ® (18 μg once daily) and is now also approved as an aqueous solution delivered via the Respimat ® Soft Mist™ Inhaler (5 μg once daily, 2 puffs of 2.5 µg). Several studies have compared the efficacy of tiotropium HandiHaler (18 μg once daily) with different doses of Respimat. We aimed to compare available bronchodilator efficacy data of once-daily Respimat 1.25, 2.5, 5, 10, 20 µg, and HandiHaler 18 µg to investigate which dose of tiotropium delivered by Respimat is the closest match to tiotropium HandiHaler. Methods Evaluation of six clinical trials (duration from 3 weeks to 2–3 years) that included lung function measures (trough forced expiratory volume in 1 s and trough forced vital capacity) as key outcomes. Results In the six trials, bronchodilator efficacy of Respimat 5 μg and HandiHaler 18 μg was similar; however, reduced bronchodilator efficacy was observed with lower doses of Respimat (1.25 and 2.5 μg). Conclusion These findings support the use of the marketed once-daily dose of Respimat 5 μg for the maintenance treatment of patients with COPD. Funding Boehringer Ingelheim.