SESSION TITLE: COPD Posters V
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: To determine whether the previously reported improvements in lung function and asthma control following once-daily tiotropium Respimat® (tioR) add-on therapy in adults with moderate symptomatic asthma are influenced by LABA use prior to screening.
METHODS: Two replicate, 24-week, Phase III, randomized, double-blind, parallel-group trials (NCT01172808/NCT01172821) of once-daily tioR 5μg or tioR 2.5μg, twice-daily salmeterol (sal) hydrofluoroalkane metered-dose inhaler 50µg, or placebo (pbo; identical devices in a double-dummy protocol), each as add-on to medium-dose ICS (400-800μg budesonide or equivalent), in adults with moderate symptomatic asthma. Patients were required to have received stable medium-dose ICS±LABA for ≥4 weeks prior to screening; LABAs were not permitted during the 4-week run-in or treatment periods. The three co-primary endpoints at Week 24 were peak and trough FEV1 responses (difference from baseline) in the individual trials and seven-question Asthma Control Questionnaire (ACQ-7) responder rate; post hoc analyses were performed according to patients’ LABA use prior to screening.
RESULTS: 2103 patients were randomized. In the full analysis set, 309, 319, 323, and 320 patients received treatment with a LABA within 3 months before screening in the tioR 5 µg, tioR 2.5µg, sal, and pbo treatment groups, respectively. At Week 24, tioR add-on therapy significantly improved lung function, compared with pbo, independent of prior LABA use. Adjusted mean difference ± standard error for prior and no prior LABA use at screening: peak FEV1, tioR 5µg, 196±25 and 168±31mL, tioR 2.5µg, 220±25 and 229±31mL, sal, 187±25 and 211±31mL (treatment-by-subgroup interaction p=0.8919); trough FEV1, tioR 5µg, 151±27 and 141±33mL, tioR 2.5µg, 177±27 and 186±34mL, sal, 101±27 and 136±33mL (p=0.8992). The proportion of patients classed as ACQ-7 responders (improvement in score ≥0.5) at Week 24 was greater following tioR add-on therapy, compared with pbo, independent of whether patients had (63.4, 61.8, 67.2, and 56.3% for the 5µg, 2.5µg, sal, and pbo treatment groups, respectively) or had not (65.7, 68.9, 65.6, and 60.1%, respectively) previously received LABA therapy.
CONCLUSIONS: Once-daily tioR add-on to medium-dose ICS improves lung function and asthma control, compared with pbo, in adults with moderate symptomatic asthma, independent of patients’ LABA use prior to screening.
CLINICAL IMPLICATIONS: Once-daily tiotropium Respimat® is an efficacious add-on to medium-dose ICS in adults with moderate symptomatic asthma.
DISCLOSURE: Leon Greos: Other: Research from Boehringer Ingelheim Petra Moroni-Zentgraf: Employee: Boehringer Ingelheim Michael Engel: Employee: Boehringer Ingelheim Reinhold Luehmann: Employee: Boehringer Ingelheim Huib Kerstjens: Consultant fee, speaker bureau, advisory committee, etc.: rom Boerhringer an d Pfizer, in relation to the work presented. As consultant, advisory baord member, and as principal investigator and recruiter, Consultant fee, speaker bureau, advisory committee, etc.: From Almirall, to my institution for consultancies, Consultant fee, speaker bureau, advisory committee, etc.: From Novartis, to my institution for consultancies The following authors have nothing to disclose: William Berger
SPIRIVAÂ® (tiotropium) RespimatÂ® is approved for use in asthma in the EU, Japan and many other countries. The indication varies by country. It is currently being reviewed by the US regulatory authorities.