Long-Term Once-Daily Tiotropium Respimat® Is Well Tolerated and Maintains Efficacy over 52 Weeks in Patients with Symptomatic Asthma in Japan: A Randomised, Placebo-Controlled Study

摘要: Background This study assessed the long-term safety and efficacy of tiotropium Respimat, a long-acting inhaled anticholinergic bronchodilator, in asthma, added on to corticosteroids (ICS) with or without β2-agonist (LABA). Methods 285 patients symptomatic despite treatment ICS±LABA, were randomised 2:2:1 once-daily 5 μg, 2.5 μg placebo for 52 weeks (via Respimat SoftMist inhaler) double-blind, placebo-controlled, parallel-group (NCT01340209). Primary objective: describe profile tiotropium. Secondary end points included: trough forced expiratory volume 1 second (FEV1) response; peak flow rate (PEFR) seven-question Asthma Control Questionnaire (ACQ-7) score. Results At Week 52, adverse-event (AE) rates 88.6%, 86.8% 89.5%, respectively. Commonly reported AEs nasopharyngitis (48.2%, 44.7%, 42.1%), asthma (28.9%, 29.8%, 38.6%), decreased PEFR (15.8%, 7.9%, 21.1%), bronchitis (9.6%, 13.2%, 7.0%), pharyngitis (7.9%, 3.5%) gastroenteritis (10.5%, 3.5%, 5.3%). In groups, 8.8%, 5.3% drug-related AEs; 3.5% 15.8% serious AEs. worsening was only AE more than one patient. At adjusted mean FEV1 responses significantly higher (but not μg) versus placebo. ACQ-7 responder at 24. Conclusions The comparable that associated mild moderate, non-serious ICS±LABA therapy. Compared placebo, but improved lung function symptoms, supporting dose. Trial Registration ClinicalTrials.gov NCT01340209