Search results for "Olodaterol"

P254 Once-daily Tiotropium And Olodaterol Fixed-dose Combination Via The Respimat(R) Improves Outcomes Versus Mono-components In Copd In Two 1-year S…

2014

Introduction Tiotropium (T), a once-daily long-acting muscarinic antagonist, is a well-established first-line maintenance treatment in chronic obstructive pulmonary disease (COPD); olodaterol (O) is a once-daily long-acting β 2 -agonist that has recently gained approval in several countries. Two Phase III replicate pivotal studies assessed the efficacy and safety of fixed-dose combinations of T and O (T+O) delivered via Respimat ® Soft Mist™ inhaler in patients with GOLD 2–4 COPD. Methods Two 52-week, double-blind, parallel-group studies randomised 5162 patients to O 5 µg, T 2.5 µg, T 5 µg, T+O 2.5/5 µg or T+O 5/5 µg. Primary efficacy end points were trough forced expiratory volume in 1 sec…

P256 Safety Of Once-daily Tiotropium And Olodaterol Fixed-dose Combination Via The Respimat In Chronic Obstructive Pulmonary Disease In Two 1-year St…

2014

Introduction The fixed-dose combination (FDC) of tiotropium (T), a once-daily long-acting muscarinic antagonist, and olodaterol (O), a once-daily long-acting β 2 -agonist, is currently being evaluated in chronic obstructive pulmonary disease (COPD). Two 52-week, Phase III replicate pivotal studies were conducted to assess the efficacy and safety of FDCs of T and O (T+O) delivered via Respimat® Soft Mist™ inhaler in patients (pts) with GOLD Stage 2–4 COPD. Pooled safety data from the two studies are presented here. Methods These were double-blind, randomised, parallel-group studies with 5 arms: O 5 µg, T 2.5 µg, T 5 µg, T+O 2.5/5 µg, T+O 5/5 µg. Key inclusion criteria were: age ≥40 years, di…

P125 Tiotropium plus olodaterol combination therapy provides lung-function benefits when compared to tiotropium alone, irrespective of prior treatmen…

2015

Rationale Tiotropium plus olodaterol (T+O) is a novel once-daily combination of the long-acting muscarinic antagonist (LAMA) tiotropium (T) and the recently approved long-acting β 2 -agonist (LABA) olodaterol, for use as maintenance treatment in chronic obstructive pulmonary disease (COPD). These post hoc analyses of data from the two pivotal 1-year TONADO studies determined whether treatment with a long-acting bronchodilator (LABD) prior to randomisation affected the lung-function benefits of T+O 5/5 µg (via Respimat®) compared to T 5 µg (via Respimat®). Methods In the studies, 2124 patients had not received prior LABD treatment (T+O n = 426; T n = 454) and 3038 patients had (T+O n = 603, …

P121 Characteristics of COPD patients with and without maintenance treatment at baseline, by GOLD stage: TONADO: Abstract P121 Table 1

2015

Rationale The efficacy and safety of the once-daily combination of tiotropium (T), a long-acting muscarinic antagonist (LAMA), and olodaterol (O), a long-acting β 2 -agonist (LABA), for the treatment of chronic obstructive pulmonary disease (COPD) has been established. We investigated whether there was a difference in the characteristics of COPD patients with and without baseline maintenance treatment. Methods Two replicate, randomised, 52-week, double-blind, parallel-group, Phase III trials (NCT01431274; NCT01431287; n = 5162) assessed the efficacy and safety of once-daily treatment with T+O (2.5/5 μg; 5/5 μg; Respimat® inhaler) compared to the individual components. Baseline characteristi…

Effect of long-acting β2-agonists olodaterol and formoterol on heart rate and blood pressure in chronic obstructive pulmonary disease patients

2018

Abstract Background Cardiovascular comorbidities are common in chronic obstructive pulmonary disease (COPD), and elevated heart rate reflects increased cardiovascular risk over time, which is associated with unfavourable neurohumoral activation. Long-acting β 2 -agonists (LABAs) are established treatments in COPD, but potentially increase heart rate. We report a post hoc pooled analysis of the effect of olodaterol (5 or 10 μg) or formoterol (12 μg) on heart rate and blood pressure (BP) in Global Initiative for Chronic Obstructive Lung Disease Stage 2–4 COPD patients. Methods Four randomised, double-blind, placebo-controlled, Phase III studies were analysed. Changes in heart rate and systoli…

S61 Analysis of the efficacy and safety of the combination of tiotropium + olodaterol in patients with COPD by previous usage of inhaled corticostero…

2015

Rationale Tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β 2 -agonist (both administered once daily), have been studied as a once-daily combination. Two Phase III studies have demonstrated that T+O significantly improved lung function and symptoms over T and O monotherapy treatments in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). 1 During these studies, patients were allowed to continue existing treatment with inhaled corticosteroids (ICS); this analysis was conducted to determine the effects of study treatment in patients receiving or not receiving ICS as reported at baseline. Methods A total of 5162 patients we…

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

2018

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 fluticasone propionate/salmeterol on left ventricular filling and lung hyperinflation in patients with COPD

2020

This exploratory, randomised, double-blind, double-dummy, multicentre, cross-over study explored the effect of 6 weeks of treatment with tiotropium/olodaterol (T/O) versus fluticasone propionate/salmeterol (F/S) on left ventricular filling in patients with chronic obstructive pulmonary disease with functional residual capacity (FRC) >120% predicted and postbronchodilator improvement of FRC ≥7.5%. Overall, 76 patients were randomised across nine sites. Treatment with T/O or F/S increased left ventricular end-diastolic volume index from baseline (adjusted mean change: T/O: 2.317 mL/m2, F/S: 2.855 mL/m2), with no statistically significant difference between treatments. However, T/O resulted…

Small airway disease (SAD) is associated with respiratory symptoms and relevant for therapy in early COPD

2020

Background: SAD is common in patients with COPD. Occurring early in the course of the disease, it is frequently missed by currently used diagnostic tests. Multiple breath washout (MBW) testing detects ventilation heterogeneity (VH) while oscillometry (OS) assesses peripheral obstruction, both associated with SAD. We therefore set out to evaluate the presence and symptoms of SAD in patients with early COPD. Methods: We prospectively evaluated 26 patients (FEV1 77±19% pred., 88% GOLD I/II). In an 8-week cross-over design, the effect of dual bronchodilatation (tiotropium/olodaterol, T/O) on lung function and symptoms (CAT) was compared to monotherapy (formoterol). Lung function was assessed by…