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Ronald Dahl, Alan Kaplan
BACKGROUND: In many countries worldwide, the long-acting anticholinergic drug tiotropium is available as a dry powder formulation delivered by means of the HandiHaler® inhalation device and as an aqueous solution delivered via the Respimat® Soft Mist™ Inhaler. Tiotropium HandiHaler® is a single-dose, dry powder, breath-actuated inhaler that provides delivered doses and lung deposition of tiotropium that are, over a wide range, not influenced by the severity of chronic obstructive pulmonary disease (COPD)...
October 11, 2016: BMC Pulmonary Medicine
Ching Kuo Tan, Gui Quan Say, James B Geake
Tiotropium bromide is a long-acting inhaled muscarinic antagonist used in patients with chronic respiratory disease. It has been available since 2002 as a single-dose dry powder formulation via the HandiHaler(®) dry powder inhaler (DPI) device, and since 2007 as the Respimat(®) SoftMist™ Inhaler (SMI). The latter is a novel method of medication delivery that utilizes a multidose aqueous solution to deliver the drug as a fine mist. Potential benefits include more efficient drug deposition throughout the respiratory tract, reduced systemic exposure, and greater ease of use and patient satisfaction compared with the use of HandiHaler DPI...
2016: Therapeutics and Clinical Risk Management
Job Fm van Boven, Janwillem Wh Kocks, Maarten J Postma
PURPOSE: The fixed-dose dual bronchodilator combination (FDC) of tiotropium and olodaterol showed increased effectiveness regarding lung function and health-related quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with the use of its mono-components. Yet, while effectiveness and safety have been shown, the health economic implication of this treatment is still unknown. The aim of this study was to assess the cost-utility and budget impact of tiotropium-olodaterol FDC in patients with moderate to very severe COPD in the Netherlands...
2016: International Journal of Chronic Obstructive Pulmonary Disease
David M G Halpin
Despite current therapeutic approaches asthma remains uncontrolled in a significant proportion of patients. Short-acting anticholinergic bronchodilators have a very long history of use in asthma, and recent data confirms the importance of acetylcholine as both a bronchoconstrictor and as a regulator of inflammation and remodeling in the lungs. Data from a comprehensive clinical trial programme, as well as use in primary care, show the efficacy and safety of tiotropium in adults with mild to moderate asthma when it is added to ICS and in severe asthma when it is added to high doses of ICS plus LABA, as well as in adolescents...
2016: World Allergy Organization Journal
Masakazu Ichinose, Hiroyuki Taniguchi, Ayako Takizawa, Lars Grönke, Lazaro Loaiza, Florian Voß, Yihua Zhao, Yoshinosuke Fukuchi
BACKGROUND: The efficacy and safety of once-daily tiotropium + olodaterol (T+O) maintenance treatment was demonstrated in the large, multinational, replicate, randomized, Phase III, Tonado(®) 1 (NCT01431274) and 2 (NCT01431287) studies in patients with moderate to very severe COPD. However, there may be racial differences in the effects of T+O on lung function in patients with COPD. METHODS: In this Tonado(®) subgroup analysis, we assessed efficacy and safety of T+O in Japanese participants...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Christian Vogelberg
Asthma is a chronic inflammatory airway disease, and its treatment is frequently challenging despite detailed national and international guidelines. While basic anti-inflammatory therapy usually consists of inhaled corticosteroids in doses adapted to the asthma severity, add-on treatment with bronchodilators is essential in more severe asthma. Only recently, the long-acting anticholinergic tiotropium was introduced into the GINA guidelines. This review reports on the studies that have been performed with tiotropium in adult asthmatic patients...
September 9, 2016: Therapeutic Advances in Respiratory Disease
Leonardo M Fabbri, Edward M Kerwin, Selwyn Spangenthal, Gary T Ferguson, Roberto Rodriguez-Roisin, James Pearle, Sanjay Sethi, Chad Orevillo, Patrick Darken, Earl St Rose, Tracy Fischer, Michael Golden, Sarvajna Dwivedi, Colin Reisner
BACKGROUND: This study forms part of the first complete characterization of the dose-response curve for glycopyrrolate (GP) delivered using Co-Suspension™ Delivery Technology via a metered dose inhaler (MDI). We examined the lower GP MDI dose range to determine an optimal dose for patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). METHODS: This randomized, double-blind, chronic-dosing, balanced incomplete-block, placebo-controlled, crossover study compared six doses of GP MDI (18, 9, 4...
2016: Respiratory Research
Roberto Rodriguez-Roisin, Kay Tetzlaff, Henrik Watz, Emiel Fm Wouters, Bernd Disse, Helen Finnigan, Helgo Magnussen, Peter Ma Calverley
The WISDOM study (NCT00975195) reported a change in lung function following withdrawal of fluticasone propionate in patients with severe to very severe COPD treated with tiotropium and salmeterol. However, little is known about the validity of home-based spirometry measurements of lung function in COPD. Therefore, as part of this study, following suitable training, patients recorded daily home-based spirometry measurements in addition to undergoing periodic in-clinic spirometric testing throughout the study duration...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Ronald Dahl, Michael Engel, Daniel Dusser, David Halpin, Huib A M Kerstjens, Liliana Zaremba-Pechmann, Petra Moroni-Zentgraf, William W Busse, Eric D Bateman
BACKGROUND: Tiotropium, a long-acting anticholinergic bronchodilator, has demonstrated efficacy and safety as add-on therapy to inhaled corticosteroids (ICS), with or without other maintenance therapies, in patients with symptomatic asthma. OBJECTIVE: To evaluate safety and tolerability of tiotropium delivered via the Respimat(®) device, compared with placebo, each as add-on to at least ICS therapy, in a pooled sample of adults with symptomatic asthma at different treatment steps...
September 2016: Respiratory Medicine
Christianne M Blais, Beth E Davis, Donald W Cockcroft
UNLABELLED: The duration of bronchoprotection against methacholine-induced bronchoconstriction by long-acting muscarinic antagonists (LAMA's) in asthmatics and whether these drugs differ in their pharmacodynamic properties remain to be determined. The most recent published guidelines for methacholine challenge testing (MCT) suggest that LAMA's should be abstained from for 48 h prior to testing, perhaps one week in the case of tiotropium. The objectives were to determine and compare the duration of protection of a single dose of two different LAMA's, tiotropium and glycopyrronium, against methacholine-induced bronchoconstriction...
September 2016: Respiratory Medicine
Kirsten Koehorst-Ter Huurne, Sharina Kort, Job van der Palen, Wendy Jc van Beurden, Kris Ll Movig, Paul van der Valk, Marjolein Brusse-Keizer
BACKGROUND: Poor adherence to inhaled medications in COPD patients seems to be associated with an increased risk of death and hospitalization. Knowing the determinants of nonadherence to inhaled medications is important for creating interventions to improve adherence. OBJECTIVES: To identify disease-specific and health-related quality of life (HRQoL) factors, associated with adherence to inhaled corticosteroids (ICS) and tiotropium in COPD patients. METHODS: Adherence of 795 patients was recorded over 3 years and was deemed optimal at >75%-≤125%, suboptimal at ≥50%-<75%, and poor at <50% (underuse) or >125% (overuse)...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Samy Suissa, Sophie Dellaniello, Pierre Ernst
BACKGROUND: Long-acting bronchodilators, including long-acting beta2-agonists (LABA) and the anticholinergic tiotropium, are recommended as initial maintenance therapy in COPD. Studies to date have been limited in size and reported ambivalent results on the comparative risk of cardiovascular, cerebrovascular and pulmonary adverse events between these two long-acting bronchodilators. Moreover, little information is available for the period when treatment is first initiated, a time when subjects may be especially at risk...
August 20, 2016: Chest
Dejan Radovanovic, Marco Mantero, Giuseppe Francesco Sferrazza Papa, Vincenzo Valenti, Stefano Aliberti, Fabiano Di Marco, Pierachille Santus
INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is characterized by a high disability and increasing mortality. Bronchodilators are the cornerstone of pharmacological treatment in COPD, while therapeutic optimization with an improvement in symptoms and compliance represent the actual goals. This has led to the development of devices that combine different classes of inhalatory drugs. Recently, a novel combination of the long acting antimuscarinic agent glycopyrronium bromide and the beta2-agonist formoterol fumarate has been developed in a metered dose inhaler delivery system...
October 2016: Expert Review of Respiratory Medicine
Arthur F Gelb, Jay A Nadel
No abstract text is available yet for this article.
October 2016: Journal of Allergy and Clinical Immunology
Huib A M Kerstjens, Petra Moroni-Zentgraf, Donald P Tashkin, Ronald Dahl, Pierluigi Paggiaro, Mark Vandewalker, Hendrik Schmidt, Michael Engel, Eric D Bateman
BACKGROUND: Many patients with asthma remain symptomatic despite treatment with inhaled corticosteroids (ICS) with or without long-acting β2-agonists (LABAs). Tiotropium add-on to ICS plus a LABA has been shown to improve lung function and reduce exacerbation risk in patients with symptomatic asthma. OBJECTIVE: To determine whether the efficacy of tiotropium add-on therapy is dependent on patients' baseline characteristics. METHODS: Two randomized, double-blind, parallel-group, twin trials (NCT00772538 and NCT00776984) of once-daily tiotropium Respimat(®) 5 μg add-on to ICS plus a LABA were performed in parallel in patients with severe symptomatic asthma...
August 2016: Respiratory Medicine
Nanshan Zhong, Hwa S Moon, Kwan H Lee, Aziah A Mahayiddin, Watchara Boonsawat, Marie G D Isidro, ChunXue Bai, Achim Mueller, Norbert Metzdorf, Antonio Anzueto
BACKGROUND AND OBJECTIVE: The TIOtropium Safety and Performance In Respimat (TIOSPIR) trial showed similar safety and exacerbation efficacy profiles for tiotropium Respimat and HandiHaler in patients with COPD. The TIOSPIR results for patients in Asia are presented here. METHODS: TIOSPIR evaluated once-daily tiotropium Respimat 5 and 2.5 µg with HandiHaler 18 µg in patients with COPD. Primary endpoints included time to death and time to first COPD exacerbation...
November 2016: Respirology: Official Journal of the Asian Pacific Society of Respirology
Pınar Saraç, Abdullah Sayıner
INTRODUCTION: The treatment of COPD (Chronic Obstructive Pulmonary Disease) aims to improve the patients's well-being and to reduce mortality, morbidity and the development of exacerbations. This study was thus designed to compare the efficacy and tolerability of salmeterol/fluticasone combination with tiotropium in patients with moderate COPD. MATERIALS AND METHODS: This was an open, prospective, randomized trial in COPD patients whose FEV1 (forced expiratory volume in 1 second) levels were between 80% and 50% predicted...
June 2016: Tüberküloz Ve Toraks
Jaime Algorta, Laura Andrade, Marta Medina, Valentin Kirkov, Sacha Arsova, Fumin Li, Jingduan Chi
BACKGROUND AND OBJECTIVE: A novel tiotropium bromide monodose capsule dry powder inhaler (DPI) formulation and device have been developed. The formulation was based on a spray-dried matrix that enhances the aerosolizaton properties, allowing a less active tiotropium metered dose (13 µg/capsule) while maintaining the same delivered dose (10 µg/actuation). This study describes the pharmacokinetic bioequivalence to the reference product. METHODS: This randomized, two-stage, crossover, semi-replicate (three-way) study was performed in healthy volunteers...
September 2016: Clinical Drug Investigation
Dave Singh, M Reza Maleki-Yazdi, Lee Tombs, Ahmar Iqbal, William A Fahy, Ian Naya
BACKGROUND: Minimizing the risk of disease progression and exacerbations is the key goal of COPD management, as these are well-established indicators of poor COPD prognosis. We developed a novel composite end point assessing three important aspects (lung function, health status, and exacerbations) of worsening in COPD. The objective was to determine whether dual bronchodilation with umeclidinium/vilanterol (UMEC/VI) reduces clinically important deteriorations (CIDs) in COPD versus placebo or bronchodilator monotherapy...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Jose M Marin, Kai M Beeh, Andreas Clemens, Walter Castellani, Lennart Schaper, Dinesh Saralaya, Anthony Gunstone, Ricard Casamor, Konstantinos Kostikas, Maryam Aalamian-Mattheis
BACKGROUND: Morning symptoms associated with COPD have a negative impact on patients' quality of life. Long-acting bronchodilators with rapid onset may relieve patients' symptoms. In the Symptoms and Pulmonary function in the moRnING study, we prospectively compared the rapid onset bronchodilator profile of glycopyrronium (GLY) and tiotropium (TIO) during the first few hours after dosing in patients with moderate-to-severe COPD. METHODS: Patients were randomized (1:1) to receive either once-daily GLY (50 μg) or TIO (18 μg) and corresponding placebos in a cross-over design for 28 days...
2016: International Journal of Chronic Obstructive Pulmonary Disease
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