Search results for "Tiotropium"

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

2017

A dose-ranging study of indacaterol in obstructive airways disease, with a tiotropium comparison.

2008

This dose-ranging study assessed the bronchodilator efficacy and tolerability of indacaterol, a novel once-daily inhaled beta2-agonist, in subjects clinically diagnosed with COPD. Comparative data with tiotropium were collected. In the double-blind, core period of the study, 635 subjects with COPD (prebronchodilator FEV(1)40% of predicted and > or =1.0L; FEV1/FVC <70%) were randomized to receive indacaterol 50, 100, 200 or 400microg or placebo via multi-dose dry powder inhaler, or indacaterol 400microg via single-dose dry powder inhaler, once daily for 7 days. After completing double-blind treatment and washout, a subset of subjects from each treatment group entered an open-label extension …

Efficacy of once-daily tiotropium Respimat in adults with asthma at GINA Steps 2-5.

2020

Tiotropium Respimat is an efficacious add-on to maintenance treatment in patients with symptomatic asthma. Currently, the Global Initiative for Asthma (GINA) strategy recommends tiotropium for patients at Steps 4–5. To assess the clinical benefits of tiotropium Respimat across asthma severities, GINA Steps 2–5, a post hoc analysis of five double-blind trials (12–48-weeks; patients aged 18–75 years) investigated the effect of tiotropium Respimat, 5 μg or 2.5 μg, versus placebo, on peak forced expiratory volume in 1 s (FEV1) within 3 h post-dose (FEV1(0–3h)) response, and Asthma Control Questionnaire-7 (ACQ-7) responder rate. GINA step grouping was based on patients’ background treatment regi…

Tiotropium - ein langwirksames, inhalatives Anticholinergikum zur Therapie der chronisch-obstruktiven Lungenerkrankung (COPD)

2003

Anticholinergics are agents of first choice for the symptomatic treatment of patients with COPD. Tiotropium (Ba 679 BR, Spiriva) is a long-acting inhaled anticholinergic designed for once-daily bronchodilator treatment of COPD. Tiotropium is a selective antagonist of pulmonary M1 and M3 muscarinic receptor subtypes, that produces a long-lasting (24 hours), dose-dependent bronchodilation and bronchoprotection against constrictive stimuli, e. g. methacholine, following inhalation of single doses. Clinical trials with tiotropium in COPD patients over a maximum treatment duration of one year have confirmed a persisting bronchodilator effect of tiotropium compared with placebo and ipratropium, a…

Efficacy and safety of indacaterol and tiotropium in COPD patients according to dyspnoea severity.

2013

Background Guidelines for chronic obstructive pulmonary disease (COPD) recommend that treatment choices be based partly on symptoms. Methods A post-hoc analysis of pooled data from clinical studies compared the efficacy and safety of once-daily inhaled bronchodilators indacaterol (150 and 300 μg) and open-label tiotropium (18 μg) according to baseline dyspnoea severity on the modified Medical Research Council (mMRC) scale in patients with COPD (mMRC scores <2 = ‘less dyspnoea’; scores ≥2 = ‘more dyspnoea’). Outcomes were assessed after 26 weeks. Results The analysis included 3177 patients. In patients with less dyspnoea: indacaterol (both doses) improved 24-h post-dose (‘trough’) forced exp…

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…

Evidenz für eine frühzeitige Therapie der COPD mit Tiotropium

2012

Hintergrund: Die Wirksamkeit von Tiotropium versus Kontrolle wurde in einer praspezifizierten Subgruppenanalyse der 4-Jahres-Studie „Understanding Potential Long-term Impacts on Function with Tiotropium“ bei Patienten mit chronisch obstruktiver Lungenerkrankung (COPD) mittleren Schweregrades (GOLD II) untersucht und erstmals den gepoolten Ergebnissen aus den schwereren Krankheitsstadien (GOLD III/IV) gegenubergestellt. Methode: Randomisierte multizentrische, doppelblinde, kontrollierte Studie mit parallelem Gruppenvergleich bei 5993 Patienten uber 4 Jahre. Die Patienten erhielten entweder Tiotropium 18 µg einmal taglich oder Plazebo. Als Endpunkte wurden der jahrliche FEV1-Abfall und weiter…

Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD.

2011

Two, once daily (q.d.) inhaled bronchodilators are available for the treatment of chronic obstructive pulmonary disease (COPD): the β(2)-agonist indacaterol and the anticholinergic tiotropium. This blinded study compared the efficacy of these two agents and assessed their safety and tolerability. Patients with moderate-to-severe COPD were randomised to treatment with indacaterol 150 μg q.d. (n=797) or tiotropium 18 μg q.d. (n=801) for 12 weeks. After 12 weeks, the two treatments had similar overall effects on "trough" (24 h post-dose) forced expiratory volume in 1 s. Indacaterol-treated patients had greater improvements in transition dyspnoea index (TDI) total score (least squares means 2.0…