Tiotropium Respimat® in asthma: a double-blind, randomised, dose-ranging study in adult patients with moderate asthma

• Published in: Respiratory research 2014-06, Vol.15 (1), p.61-61
• Main Authors: Beeh, Kai-Michael, Moroni-Zentgraf, Petra, Ablinger, Othmar, Hollaenderova, Zuzana, Unseld, Anna, Engel, Michael, Korn, Stephanie
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Adult; Asthma; Asthma - diagnosis; Asthma - drug therapy; Bronchodilator Agents - administration & dosage; Chronic obstructive pulmonary disease; Clinical trials; Compensation; Confidence intervals; Corticoids; Cross-Over Studies; Dose-Response Relationship, Drug; Double-Blind Method; Drug therapy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Pharmaceutical industry; Respiratory function; Risk reduction; Scopolamine Derivatives - administration & dosage; Studies; Tiotropium Bromide
• ISSN: 1465-9921; 1465-993X; 1465-993X; 1465-9921
• DOI: 10.1186/1465-9921-15-61

Tiotropium, a once-daily long-acting anticholinergic bronchodilator, when administered via Respimat® SoftMist™ inhaler (tiotropium Respimat®) significantly reduces the risk of severe exacerbations and improves lung function in patients with severe persistent asthma that is not fully controlled despite using inhaled corticosteroids (ICS) and long-acting β2-agonists. To further explore the dose-response curve in asthma, we investigated the efficacy and safety of three different doses of tiotropium Respimat® as add-on to ICS in symptomatic patients with moderate persistent asthma. In this randomised, double-blind, placebo-controlled, four-way crossover study, patients were randomised to tiotropium Respimat® 5 μg, 2.5 μg or 1.25 μg or placebo Respimat®, once daily in the evening. Each treatment was administered for 4 weeks, without washout between treatment periods. Eligibility criteria included ≥60% and ≤90% of predicted normal forced expiratory volume in 1 second (FEV1) and seven-question Asthma Control Questionnaire mean score of ≥1.5. Patients were required to continue maintenance treatment with stable medium-dose ICS for at least 4 weeks prior to and during the treatment period. Long-acting β2-agonists were not permitted during the treatment phase. The primary efficacy end point was peak FEV1 measured within 3 hours after dosing (peak FEV1(0-3h)) at the end of each 4-week period, analysed as a response (change from study baseline). In total, 149 patients were randomised and 141 completed the study. Statistically significant improvements in peak FEV1(0-3h) response were observed with each tiotropium Respimat® dose versus placebo (all P