Long-term safety of tiotropium/olodaterol Respimat^® in patients with moderate-to-very severe COPD and renal impairment in the TONADO^® studies.

ABSTRACT:

Introduction

The safety, lung function efficacy, and symptomatic benefits of combined tiotropium and olodaterol in patients with COPD were established in the 1-year TONADO^® studies (NCT01431274; NCT01431287). As tiotropium is predominantly excreted by the kidneys, the long-term safety profile of tiotropium/olodaterol was investigated in patients with renal impairment in a prespecified safety analysis of the TONADO studies.

Methods

These were 2 replicate, randomized, double-blind, parallel-group, 52-week Phase III studies that assessed tiotropium/olodaterol compared with tiotropium or olodaterol alone (all via Respimat^®) in patients with moderate-to-very severe COPD. In this analysis, renal impairment was defined as mild (creatinine clearance [CLcr] 60-8

SUBMITTER: LaForce C 

PROVIDER: S-EPMC5987861 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature