Impact of grouping patients by 2017 GOLD strategy assessment criteria: a post hoc analysis of the TONADO and OTEMTO trials

Introduction: Compared to the 2014 scheme, the 2017 GOLD COPD strategy uses only symptoms and exacerbation history to group patients, and no longer gives reference to the severity of airflow limitation. Aims: This post hoc analysis of TONADO and OTEMTO data aims to determine the impact of updated assessment criteria on patient classification and characteristics within these groups. Methods: TONADO (NCT01431274/NCT01431287; N=5162) and OTEMTO (NCT01964352/NCT02006732; N=1621) Phase III trials investigated efficacy and safety of tiotropium+olodatorol fixed-dose combination in COPD patients. In this analysis, patients were classed as GOLD A–D by the 2017 or 2014 criteria. In TONADO the mMRC Dy…

The impact of grouping patients by the 2017 GOLD COPD strategy on response to therapy: post hoc results from the TONADO tiotropium+olodaterol trials

Introduction: In the 2017 GOLD COPD strategy the classification of patients by assessment of symptoms and history of exacerbation is used to guide treatment choices. The previous strategy also included lung function. Aims and objectives: To investigate the effect of the 2017 classification on an analysis of the efficacy of tiotropium+olodaterol (T+O) in GOLD stage A/B patients with COPD. Methods: Patients from the Phase III, replicate 52-week TONADO studies (NCT01431274, NCT01431287), who received T+O or the mono-components, were classed as GOLD A/B or C/D by the 2017 strategy (using exacerbation history) or 2014 strategy (using lung function and exacerbation history). Since mMRC Dyspnoea S…

Analysis of Rescue Medication Use over 1 Year in Patients Receiving LAMA, LABA, or Combination Maintenance Treatment for COPD in the TONADO Studies

Determining SGRQ and TDI responder rates across the duration of clinical trials: Results from tiotropium + olodaterol in COPD

Introduction: Patient-reported outcomes (PROs) are important in COPD for understanding patients’ symptoms and experience of the disease. Responder rates at specific timepoints are frequently used to analyse clinically important improvements in PROs. Alternatively, responders can be defined using average PRO improvement vs. baseline over the whole study period or the last two timepoints, as recently discussed by the FDA. Aims and objectives: To compare three techniques for determining responder rates of St. George’s Respiratory Questionnaire (SGRQ) and transition dyspnoea index (TDI). Methods: Two double-blind, replicate, Phase III, 52-week TONADO trials compared tiotropium + olodaterol (T+O…

Benefits of Tiotropium + Olodaterol Over Tiotropium at Delaying Clinically Significant Events in Patients with COPD Classified as GOLD B