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François Maltais, Alan Hamilton, Florian Voß, M Reza Maleki-Yazdi
INTRODUCTION: During the clinical development of a fixed-dose combination of drugs, it is best practice to conduct dose-finding studies to determine the optimal dose of each component. The aims of this phase II dose-finding study were to confirm the lung function benefit of adding olodaterol to tiotropium, describe the dose-response relationship of olodaterol in combination with tiotropium 5 μg, and compare it with the dose response of olodaterol monotherapy. METHODS: In this double-blind, parallel-group trial, patients were randomized to receive either tiotropium 5 μg or a fixed-dose combination of tiotropium 5 μg with olodaterol 2 μg, 5 μg, or 10 μg, delivered once daily via the Respimat® for 4 weeks (NCT00696020)...
March 6, 2019: Advances in Therapy
Stefania Spila-Alegiani, Francesco Trotta, Roberto Da Cas, Mariangela Rossi, Mauro Venegoni, Giuseppe Traversa
The effectiveness of the tiotropium Respimat® formulation in routine clinical practice is still an open issue due to concern about the generalizability of the Tiotropium Safety and Performance in Respimat® (TIOSPIR) trial findings. Our aim was to compare the incidence of acute respiratory events between new users of tiotropium Respimat® and HandiHaler® . The study population comprised patients aged ≥45 years resident in two Italian regions who received a first tiotropium prescription (HandiHaler® or Respimat® ) between 1 July 2011 and 30 November 2013...
October 2018: COPD
Anna-Maria Ciciliani, Peter Langguth, Herbert Wachtel
Age and comorbidities can impact on the success of handling an inhaler. In this pilot study, we assessed finger strength in 62 participants (aged 5-17 years [n = 20], 18-65 years [n = 22] and > 65 years [n = 20]) by using different types of inhalers with integrated sensors (Respimat®, Breezhaler®, Aerolizer®, Genuair®, Diskus®, Ellipta®, HandiHaler®, Turbohaler® and a pressurized metered-dose inhaler [Atrovent®]). Parameters under investigation included the spontaneous and maximum achievable force and torque required to operate devices...
April 5, 2019: International Journal of Pharmaceutics
Fernando J Martinez, Roger A Abrahams, Gary T Ferguson, Leif Bjermer, Lars Grönke, Florian Voß, Dave Singh
Rationale: In symptomatic patients with COPD, the decision whether to initiate maintenance treatment with a single agent or a combination of long-acting bronchodilators remains unclear. Objective: To investigate whether baseline symptomatic status influences response to tiotropium/olodaterol treatment. Materials and methods: Post hoc analysis of the randomized OTEMTO® studies (NCT01964352; NCT02006732), in which patients with moderate-to-severe COPD received placebo, tiotropium 5 µg, tiotropium/olodaterol 2...
2019: International Journal of Chronic Obstructive Pulmonary Disease
Philip O'Hagan, Juergen Dederichs, Boomi Viswanad, Matthias Gasser, Susann Walda
Background: Good compliance in chronic obstructive pulmonary disease (COPD) is of 'paramount importance' in reducing the occurrence of acute exacerbations, hospitalisation and mortality and in improving quality of life. However, a number of studies have confirmed that long-term compliance is low and often associated with difficulties in handling maintenance inhalers. Therefore, the easier an inhaler is to use, the more likely the patient will comply with handling instructions and so, optimise control of the condition...
October 2018: Journal of Thoracic Disease
Maria Vera Cruz de Oliveira, Emilio Pizzichini, Claudia Henrique da Costa, Carlos Cezar Fritscher, Elcio Oliveira Vianna, Paulo José Zimermann Teixeira, Roberto Stirbulov, Marcelo Fouad Rabahi, Nadine Cordeiro de Pinho
The INHALATOR study was a randomized, multicentre, open label, two-period of 7 days each, crossover study, with 7 days of washout in-between, aiming to evaluate the correct use, satisfaction and preference between Breezhaler® and Respimat® devices in patients under daily use of open Spiriva® or open Onbrize® , as monotherapy for treatment of mild or moderate COPD. Patients aged ≥40 years with a smoking history of at least 10 pack-year were included in the study. Primary endpoint was the rate of correct use of each device at the first day of treatment after reading the drug leaflet information and was evaluated under the supervision of a trained evaluator...
November 2018: Respiratory Medicine
Gary T Ferguson, Roland Buhl, Ulrich Bothner, Alberto de la Hoz, Florian Voß, Antonio Anzueto, Peter M A Calverley
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...
October 2018: Respiratory Medicine
Johsuke Hara, Kazuo Kasahara, Noriyuki Ohkura, Kenta Yamamura, Tamami Sakai, Miki Abo, Naohiko Ogawa, Keigo Saeki, Hayato Koba, Satoshi Watanabe, Yuka Uchida, Yuichi Tambo, Takashi Sone, Hideharu Kimura
OBJECTIVE: In Japan, most asthma deaths occur among the elderly. We should improve the control of asthma in elderly patients to reduce the number of deaths due to asthma. This retrospective study aimed to evaluate the efficacy of tiotropium RespimatⓇ (Tio-Res) in symptomatic, never-smoking, elderly asthmatics with irreversible airflow limitation despite the use of high-dose inhaled corticosteroids (ICS) plus long-acting β2 -adrenoceptor agonists (LABA). METHODS: The Asthma Control Test™ (ACT), pulmonary function tests, morning and evening peak flow (mPEF, ePEF, respectively, evaluated with an ASSESS® peak flow meter), and respiratory impedance (assessed with MostGraph® ) were measured before and after a minimum of one year of Tio-Res 5 µg/day administration...
September 7, 2018: Drug Research
Gary T Ferguson, Richard N Dalby
Oral inhalation is the recommended delivery method of medications for the treatment of patients with chronic obstructive pulmonary disease (COPD). However, patients may struggle when using the various available inhaler platforms, and, as a result, may fail to achieve the benefit of the prescribed medication. Propellant-based, pressurized metered-dose inhaler and powder-based, dry powder inhaler devices are currently the most commonly prescribed delivery systems. Each of these devices has its own advantages and challenges...
August 2018: Postgraduate Medicine
Craig LaForce, Eric Derom, Ulrich Bothner, Isabel M Kloer, Matthias Trampisch, Roland Buhl
Introduction: The safety, lung function efficacy, and symptomatic benefits of combined tiotropium and olodaterol in patients with COPD were established in the 1-year TONADO® studies (NCT01431274; NCT01431287). As tiotropium is predominantly excreted by the kidneys, the long-term safety profile of tiotropium/olodaterol was investigated in patients with renal impairment in a prespecified safety analysis of the TONADO studies. Methods: These were 2 replicate, randomized, double-blind, parallel-group, 52-week Phase III studies that assessed tiotropium/olodaterol compared with tiotropium or olodaterol alone (all via Respimat® ) in patients with moderate-to-very severe COPD...
2018: International Journal of Chronic Obstructive Pulmonary Disease
Xiangyin Wei, Michael Hindle, Anubhav Kaviratna, Bao K Huynh, Renishkumar R Delvadia, Dennis Sandell, Peter R Byron
BACKGROUND: In vitro-in vivo correlations (IVIVC) for lung deposition may be established by testing inhalers in vitro with realistic mouth-throat (MT) models and inhalation profiles (IP). This study was designed to compare the currently available MT models and their ability to predict in vivo lung deposition. METHODS: Budelin® Novolizer® , Ventolin® Evohaler® , and Respimat® fenoterol were chosen to represent a dry powder inhaler (DPI), metered dose inhaler (MDI), and soft mist inhaler (SMI) in tests using eight MT models: small, medium, and large Virginia Commonwealth University (VCU) models; small, medium, and large oropharyngeal consortium (OPC) models, the medium adult Alberta Idealized Throat (AIT), and the United States Pharmacopeia (USP) Induction Port, with IPs that simulated those used by volunteers in lung scintigraphy studies...
June 7, 2018: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Rejmon Dedaj, Lindie Unsel
A Combination of Mepolizumab and Omaluzimab injections for severe asthma. INTRODUCTION: Patients with severe persistent asthma account for a large proportion of asthma morbidity and health care expenditures. In this case report we describe the use of a combination of omalizumab and mepolizumab in severe asthma with elevated IgE levels and eosinophilic phenotype. CASE STUDY: We are treating a 55 year old woman with severe persistent eosinophilic asthma and elevated IgE levels...
May 7, 2018: Journal of Asthma: Official Journal of the Association for the Care of Asthma
Oliver C Steinbach
The present industry update covers the period of 1 January-31 January 2018, with information sourced from company press releases, regulatory and patent agencies as well as scientific literature. Several public offerings (Gecko, Insmed), licensing (Foresee) and commercialization agreements (Alnylam, Collegium Pharmaceutical) as well as patent filings (Elute) continue to prove the sustained investments in the drug delivery market. In increasing numbers, more effective ways to deliver the active ingredient to the right location and the right dose through devices (Boehringer Ingelheim's Respimat, Medtronics' SynchroMedII) or improved compound properties through formulation (Aquestive Therapeutics' PharmFilm, Noven Pharmaceuticals' transdermal patch) are reaching the market...
May 1, 2018: Therapeutic Delivery
Chi-Yen Liang, Yi-Jen Chen, Shew-Meei Sheu, Ching-Fang Tsai, Wei Chen
Purpose: Respiratory inhalers, which directly deliver medication to the airway, are important for controlling symptoms and preventing exacerbations of chronic obstructive pulmonary disease (COPD). The inhaler misuse rate of patients with COPD in Taiwan is unclear. In this study, the inhaler techniques and patient characteristics associated with incorrect inhaler techniques among patients with COPD were evaluated. Patients and methods: This cross-sectional study enrolled 298 patients with COPD (mean age 72...
2018: International Journal of Chronic Obstructive Pulmonary Disease
Peter Ma Calverley, Antonio R Anzueto, Daniel Dusser, Achim Mueller, Norbert Metzdorf, Robert A Wise
Rationale: Exacerbations of COPD are managed differently, but whether treatment of one exacerbation predicts the likelihood of subsequent events is unknown. Objective: We examined whether the treatment given for exacerbations predicted subsequent outcomes. Methods: This was a post-hoc analysis of 17,135 patients with COPD from TIOtropium Safety and Performance In Respimat® (TIOSPIR® ). Patients treated with tiotropium with one or more moderate to severe exacerbations on study were analyzed using descriptive statistics, logistic and Cox regression analysis, and Kaplan-Meier plots...
2018: International Journal of Chronic Obstructive Pulmonary Disease
Herbert Wachtel, Mark Nagel, Michael Engel, Georges El Azzi, Ashish Sharma, Jason Suggett
BACKGROUND: When characterizing inhalation products, a comprehensive assessment including in vitro, pharmacokinetic (PK), and clinical data is required. We conducted a characterization of tiotropium Respimat® when administered with AeroChamber Plus® Flow-Vu® anti-static valved holding chamber (test VHC) with face mask in 1-5-year-olds with persistent asthmatic symptoms. METHODS: In vitro tiotropium dose and particle size distribution delivered into a cascade impactor were evaluated under fixed paediatric and adult flow rates between actuation and samplings...
April 2018: Respiratory Medicine
David Price, Dorothy L Keininger, Boomi Viswanad, Matthias Gasser, Susann Walda, Florian S Gutzwiller
Background: Nonadherence to medication and incorrect use of inhalers represent significant barriers to optimal disease management of patients with chronic obstructive pulmonary disease (COPD). Thus, health care professionals (HCPs) play a critical role in educating their patients on appropriate inhaler use and in ensuring medication adherence. However, many patients do not receive appropriate inhaler training or have not had their inhaler technique checked. Methods: The Real-life Experience and Accuracy of inhaLer use (REAL) survey was a computer-assisted, telephonic survey consisting of 23 questions gathering real-world information on correct inhaler use, inhalation technique, device attributes, adherence, dosing accuracy, training, correct device use, ease of use, and factors that influence patient adherence in commercially available inhalers delivering COPD maintenance therapy...
2018: International Journal of Chronic Obstructive Pulmonary Disease
Robert A Wise, Peter Ma Calverley, Kerstine Carter, Emmanuelle Clerisme-Beaty, Norbert Metzdorf, Antonio Anzueto
Background: Although COPD exacerbations are known to occur more frequently in winter, there is little information on hospitalizations and cause-specific mortality. This study aimed to examine seasonal variations in mortality and exacerbations in patients with COPD during the TIOtropium Safety and Performance In Respimat® (TIOSPIR® ) trial. Patients and methods: TIOSPIR was a large-scale, multicenter trial, which assessed the safety and efficacy of tiotropium delivered via HandiHaler® (18 μg once daily) or Respimat® Soft Mist™ (2...
2018: International Journal of Chronic Obstructive Pulmonary Disease
Daiki Hira, Hiroyoshi Koide, Shigemi Nakamura, Toyoko Okada, Kazunori Ishizeki, Masafumi Yamaguchi, Setsuko Koshiyama, Tetsuya Oguma, Kayoko Ito, Saori Funayama, Yuko Komase, Shin-Ya Morita, Kohshi Nishiguchi, Yasutaka Nakano, Tomohiro Terada
The patients' inhalation flow pattern is one of the significant determinants for clinical performance of inhalation therapy. However, the development of inhalation flow meters for various inhalation devices has been unable to keep up with the increasing number of newly launched inhalation devices. In the present study, we developed simple attachment orifices for the inhalation flow pattern monitoring system, which are suitable for all commercial inhalers, and investigated the efficacy of the system on the clinical inhalation instruction for patients co-prescribed dry powder inhaler (DPI) and soft mist inhaler (SMI)...
2018: PloS One
Liqun Wang, Ruirui Zhou, Xiaohui Xie
OBJECTIVE: To assess the efficacy and safety profile of tiotropium when added to low- to medium-dose inhaled corticosteroid (ICS) regimen versus low- to medium-dose ICS alone for adults with mild to moderate uncontrolled persistent asthma. DATA SOURCES: The online databases Pubmed, Embase and the Cochrane Library were searched for relevant data published up to November 14, 2017; we also conducted a supplementary search using STUDY SELECTIONS: Only randomized control trials were included in this review...
February 8, 2018: Journal of Asthma: Official Journal of the Association for the Care of Asthma
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