Search results for "Olodaterol"

P294 Benefits of tiotropium/olodaterol over tiotropium at delaying clinically significant events in patients with copd classified as gold B

2016

Rationale The once-daily combination of tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β 2 -agonist, has demonstrated efficacy and safety in COPD. Two large clinical studies (TONADO ® 1 + 2) have also demonstrated the benefits of T/O compared to the monocomponents in patients with moderate to very severe COPD. This post hoc analysis investigated whether T/O is more effective than T at delaying clinically significant events in patients with GOLD stage B COPD. Methods A total of 5162 patients were randomised to O 5 µg, T 2.5 µg, T 5 µg, T/O 2.5/5 µg or T/O 5/5 µg (delivered via Respimat ® inhaler) in two 52-week, parallel-group, double-blind studies (NC…

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

2017

Lung Deposition Using the Respimat® Soft Mist™ Inhaler Mono and Fixed-Dose Combination Therapies: An In Vitro/In Silico Analysis

2020

Tiotropium and olodaterol are mainstay treatments for chronic obstructive pulmonary disease (COPD) and yield important clinical improvements, especially when used in fixed-dose combination. Whilst previous studies have shown consistent delivery of tiotropium to the lungs with the Respimat® inhaler, no such study has been carried out for olodaterol or the components of their fixed-dose combination (TIO/OLO). Combining in vitro and in silico models, we measured the amount of drug retained in the mouth–throat area, entering the trachea and reaching the lung periphery. We applied a hybrid deposition model that considered the experimentally determined output of an Alberta throat model (in vitro …

β-Blockers in COPD

2018

Background Cardiovascular disease is a frequent comorbidity in patients with COPD. Many physicians, particularly pulmonologists, are reluctant to use β-adrenoceptor blocking agents (β-blockers) in patients with COPD, despite their proven effectiveness in preventing cardiovascular events. Methods The large (5,162 patients) phase III TONADO 1 and 2 studies assessed lung function and patient-reported outcomes in patients with moderate to very severe COPD receiving long-acting bronchodilator treatment across 1 year. This post hoc analysis characterized lung-function changes, patient-reported outcomes, and safety in the subgroup of patients receiving β-blockers in the studies. Results In total, …

Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials.

2018

Abstract Background An extensive clinical trial program supports the efficacy and safety of tiotropium/olodaterol in chronic obstructive pulmonary disease (COPD). We examined the safety of tiotropium/olodaterol compared with tiotropium in a large population of patients, focusing on cardiovascular and respiratory events. Methods Patients (n = 9942) who received once-daily tiotropium/olodaterol 5/5 μg or tiotropium 5 μg (via Respimat®) in TONADO 1 & 2 and DYNAGITO were included. The number of patients and exposure-adjusted rate of events are presented for adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, and cardiovascular and respiratory events. Findings Fewer patient…

Tiotropium + olodaterol in patients with moderate to severe COPD with chronic bronchitis and/or emphysema

2017

Introduction: Chronic bronchitis and emphysema are two COPD phenotypes that can affect pharmacologic treatment decisions. Aims: Tiotropium (T) + olodaterol (O) was established for COPD treatment in two large Phase III trials. This post hoc analysis assessed the effect of T+O on lung function, symptoms and health-related quality of life (QoL) in patients (pts) with investigator-defined bronchitis and/or emphysema. Methods: TONADO ® 1+2 were replicate, randomised, double-blind, parallel-group trials. Pts with GOLD 2–4 COPD were randomised to once-daily T+O 2.5/5 or 5/5 µg, T 2.5 or 5 µg, or O 5 µg via Respimat ® inhaler. 1 End points included forced expiratory volume in 1 second (FEV 1 ) area…

P128 Pooled safety analysis of adjudicated serious adverse events with the combination of tiotropium + olodaterol: Abstract P128 Table 1

2015

Rationale This analysis aimed to obtain a comprehensive and objective safety assessment of the combination of tiotropium (T), a long-acting muscarinic antagonist, with olodaterol (O), a long-acting β2-agonist, (T+O) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Methods Data from two, 52-week, pivotal Phase III trials investigating T+O 5/5 µg and T+O 2.5/5 µg versus T 2.5 µg, 5 µg and O 5 µg were pooled, and patient narratives and profiles of serious adverse-event (SAE) reports were reviewed by an independent Adjudication Committee. The committee members independently assessed all SAEs to determine if any deaths, hospitalisations or intubations were r…

Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4).

2015

Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials. Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-daily via Respimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0–3) response, trough FEV1 response and St George's Respiratory Questionnaire (SGRQ) total score at 24 weeks. In total, 5162 patien…

P131 Efficacy of tiotropium and olodaterol combination in patients with COPD on β-blockers: Abstract P131 Table 1

2015

Rationale The efficacy and safety of a new once-daily combination with tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β2-agonist, was established for the treatment of chronic obstructive pulmonary disease (COPD) in the TONADO studies ([NCT01431274][1]; [NCT01431287][2]). This analysis evaluates the efficacy of the combination in a subpopulation of patients receiving β-blockers in these studies. Methods Two replicate, randomised, double-blind, parallel-group, 52-week, Phase III trials assessed the efficacy and safety of T+O (2.5/5 μg; 5/5 μg; via Respimat® inhaler) once daily compared to the monocomponents. Key primary end-point data for the combined a…

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…