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Lung transporters and absorption mechanisms in the lungs
Published in Anthony J. Hickey, Heidi M. Mansour, Inhalation Aerosols, 2019
Mohammed Ali Selo, Hassan H.A. Al-Alak, Carsten Ehrhardt
P-gp in lung tissue may influence the pharmacokinetics/pharmacodynamics of inhaled drugs and may lead to drug–drug interactions. For example, the co-administration of oral verapamil with either inhaled umeclidinium bromide alone or in combination with vilanterol, two P-gp substrates, in healthy volunteers, caused a 40% increase in both bronchodilators’ area under the curve (AUC). However, the rise in the systemic concentration was of no clinical significance in terms of toxicity (41).
Globally Optimal Adaptive Trial Designs
Published in Mark Chang, John Balser, Jim Roach, Robin Bliss, Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials, 2019
Mark Chang, John Balser, Jim Roach, Robin Bliss
According to the report, “Chronic Obstructive Pulmonary Disease (COPD) Market to 2019 - Highly-Priced New Combination Products Forecast to Capture Significant Market Share and Drive Growth”, released by GBI Research, a leading business intelligence provider, “the global COPD market is estimated to currently be worth $11.3 billion, and is forecast to reach a value of $15.6 billion by 2019. Much of this growth will be fuelled by a high number of new, more efficacious and convenient products entering the market and commanding greater value compared to the therapies already in the market. The drugs driving this growth include once-daily LABA/LAMA fixed-dose combinations such as QVA-149, umeclidinium bromide/vilanterol and olodaterol/tiotropium. Despite recent patent expirations, including that of Advair Diskus (salmeterol/fluticasone propionate), a market leader, generic erosion in the COPD market may not be as pronounced as that observed in other indications. This is largely down [due] to the difficulty in replicating a fixed-dose combination therapy and the associated device.” “Although the COPD market is characterized by low diagnosis rates, campaigns to increase awareness of the disease in both patients and physicians has resulted in steadily rising diagnosis of COPD. Therefore, this has also contributed to market growth throughout the forecast period.”
Evaluating revefenacin as a therapeutic option for chronic obstructive pulmonary disease
Published in Expert Opinion on Pharmacotherapy, 2020
Sabina Antonela Antoniu, Ruxandra Rajnoveanu, Ruxandra Ulmeanu, Florin Mihaltan, Mihaela Grigore
LAMAs can be used as monotherapy in COPD with a lower disease burden, that is, less severe dyspnea, better quality of life, better lung function, and no or less severe disease exacerbations. Tiotropium bromide is the first LAMA approved in both the USA and EU for maintenance therapy in COPD. Tiotropium bromide demonstrated its therapeutic potential on both short- and long-term bases [3–5]. It was previously developed as capsules for daily inhalation route (delivering device, HandiHaler) and is currently marketed as a solution for inhalation delivered via a soft mist inhaler, called Respimat, with the same dosing schedule and comparable efficacy [6]. Subsequent LAMAs that became available for COPD were all formulated for dry powder inhalation and represented by aclidinium bromide, umeclidinium bromide, and glycopyrronium bromide, formulated for once or twice daily inhalations.
The discovery and development of aclidinium bromide for the treatment of chronic obstructive pulmonary disease
Published in Expert Opinion on Drug Discovery, 2018
Mario Malerba, Alessandro Radaeli, Giuseppe Santini, Jaymin Morjaria, Nadia Mores, Chiara Mondino, Giuseppe Macis, Paolo Montuschi
Among LAMAs, once-daily tiotropium bromide, glycopyrronium bromide, umeclidinium bromide and twice-daily aclidinium bromide are approved for maintenance treatment of COPD in several countries [4]. Single inhaler fixed-dose combinations (FDC) of LAMA/LABA, including glycopyrronium/indacaterol, umeclidinium/vilanterol, tiotropium/olodaterol, and aclidinium/formoterol are also available for pharmacological treatment of COPD patients who are not adequately controlled with a single bronchodilator [1]. Aclidinium bromide is approved and marketed for twice-daily maintenance bronchodilator treatment in patients with COPD as inhalation powder delivered through a pre-dispensed DPI [13]. Each delivered dose contains 322 μg of aclidinium corresponding to a metered dose of 400 μg of aclidinium bromide [13]. For twice-daily maintenance treatment of COPD patients, a metered dose DPI containing a combination of aclidinium bromide and formoterol fumarate dihydrate is approved [14]. Each delivered dose contains 340 μg of aclidinium, corresponding to a metered dose of 400 μg of aclidinium bromide, and 11.8 μg of formoterol fumarate dihydrate, corresponding to a metered dose of 12 μg of formoterol fumarate dehydrate [14]. First authorization for aclidinium bromide in the EU was released in 2012 [13].
Multidimensional approach for the proper management of a complex chronic patient with chronic obstructive pulmonary disease
Published in Expert Review of Respiratory Medicine, 2018
Paola Rogliani, Vito Brusasco, Leonardo Fabbri, Andrea Ungar, Elisa Muscianisi, Ilaria Barisone, Alberto Corsini, Giuseppe De Angelis
Therapeutic options for COPD include β2-agonist and anticholinergics as bronchodilators, eventually associated with inhaled corticosteroids (ICS) and phosphodiesterase-4 inhibitors or macrolides for exacerbations. Among bronchodilators, β2-agonists (salmeterol, formoterol, indacaterol, salbutamol, olodaterol, vilanterol) and anticholinergics (ipratropium bromide, oxitropium bromide, aclidinium bromide, tiotropium bromide, glycopyrronium bromide, umeclidinium bromide) are associated with functional improvement of lung function, symptom control, and quality of life [41–45]. Clinical guidelines and strategical plans for COPD management indicate that corticosteroids combined with long-acting β2-agonist (LABA) are useful to reduce the effects of chronic inflammation, since they may contribute to improve lung function, delay disease progression, and decrease symptoms and exacerbations [5,33]. However, the results of FLAME study indicate that the combination of LABA and long-acting muscarinic receptor antagonist (LAMA) was superior to the combination of LABA and inhaled glucocorticoid in ameliorating exacerbations, lung function, and health status [46]. The effect was independent on blood eosinophil levels that did not correlate with the rate of moderate or severe exacerbations [47].