@article {PaggiaroP4133, author = {P. Paggiaro and M. Engel and N. Tudoric and B. Forstner and E. Radeczky and V. Zubek and Z. Blahova and P. Moroni-Zentgraf}, title = {Phase III trial of tiotropium as add-on therapy to low-dose inhaled corticosteroids for patients with symptomatic mild persistent asthma: Design and planned analyses}, volume = {42}, number = {Suppl 57}, elocation-id = {P4133}, year = {2013}, publisher = {European Respiratory Society}, abstract = {Background: Tiotropium, a once-daily long-acting anticholinergic bronchodilator, improved lung function and reduced severe exacerbations in patients with severe symptomatic asthma despite using ICS/LABA (Kerstjens et al. NEJM 2012;367:1198-207). A Phase III, randomised, double-blind, parallel-group trial (NCT01316380) was designed to analyse tiotropium efficacy and safety versus placebo in patients with mild persistent asthma on low-dose ICS.Methods: Patients aged 18-75 years, with symptomatic asthma despite low-dose ICS (ACQ >=1.5 at screening/randomisation), diagnosed >=3 months prior to enrolment and before age 40, non-smokers or ex-smokers (>=1 year with \<10 pack-years), were included. All received stable low-dose ICS for >=4 weeks and had pre-bronchodilator FEV1 >=60\% and <=90\% of predicted and positive reversibility testing. Patients received 2.5 {\textmu}g or 5 {\textmu}g tiotropium or placebo once daily via the Respimat{\textregistered} Soft Mist{\texttrademark} Inhaler for 12 weeks in addition to daily low-dose ICS. Rescue medication (salbutamol/albuterol) was allowed throughout. The primary end point, FEV1 peak(0-3h) response (change from baseline) after 12 weeks, will be analysed using a restricted maximum likelihood-based mixed effects model with repeated measures. Secondary end points include trough FEV1 response, FVC peak(0-3h) response, FEV1 (AUC0-3h), FVC (AUC0-3h), ACQ score after 12 weeks, time to first exacerbation and rescue medication use.Conclusion: This trial provides information on the bronchodilator efficacy and safety of different doses of tiotropium versus placebo as add-on to low-dose ICS in patients with symptomatic mild persistent asthma.}, issn = {0903-1936}, URL = {https://erj.ersjournals.com/content/42/Suppl_57/P4133}, eprint = {https://erj.ersjournals.com/content/42/Suppl_57/P4133.full.pdf}, journal = {European Respiratory Journal} }