Search results for "Tiotropium-olodaterol"

Long-Term Safety of Tiotropium/Olodaterol Respimat in Patients with Moderate-to-Very Severe COPD and Renal Impairment in the TONADO Studies

2018

P296 Effect of tiotropium/olodaterol therapy on copd exacerbations in the tonado® studies

2016

Rationale The lung-function efficacy, symptomatic benefits and safety of combined tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β 2 -agonist, for the treatment of COPD, was established in the year-long TONADO ® studies (NCT01431274; NCT01431287). It is unknown if these benefits of T/O translate into a reduction in COPD exacerbation rate. Methods Two replicate, randomised, double-blind, parallel-group trials assessed T/O 2.5/5 μg and T/O 5/5 μg compared to the monocomponents T 5 μg, T 2.5 μg and O 5 µg (all delivered via Respimat ® inhaler) in patients with moderate to very severe COPD. Primary end points included lung function (forced expiratory volu…

Efficacy of Tiotropium/Olodaterol Compared with Tiotropium in Patients Naïve to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials

2019

The Effect of Tiotropium/Olodaterol versus Salmeterol/Fluticasone on Left Ventricular Function and Lung Hyperinflation in Patients with COPD

2019

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

2017

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…

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

2017

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 compared with tiotropium in patients receiving COPD LAMA at baseline: pooled analysis of 4 clinical trials

2020

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

2017

Long-Term Safety of Tiotropium/Olodaterol Respimat in Elderly Patients with Moderate to Very Severe COPD in the TONADO Studies

2018

The effect of tiotropium/olodaterol versus tiotropium on COPD exacerbation rates in patients with/without frequent exacerbation history

2019

Background: Patients with COPD with a history of frequent exacerbations are at increased risk of future exacerbations. There are limited data as to whether combining LAMA/LABA reduces exacerbation risk in all patients. We investigated whether tiotropium/olodaterol (T/O) reduced exacerbation rate versus tiotropium (tio) in patients with a range of exacerbation histories. Methods: TONADO 1+2 (NCT01431274/NCT01431287) and DYNAGITO (NCT02296138) were 52-week, parallel-group, randomised, double-blind, Phase III trials in COPD patients with FEV1 Results: There was a lower rate of moderate/severe exacerbations with T/O (0.68 per patient-year) than tio (0.77 per patient-year) (rate ratio [RR] vs ti…