Pulmonary pharmacology & therapeutics
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Pulm Pharmacol Ther · Dec 2018
Observational StudyReal-life evaluation of the clinical, functional, and hematological effects of mepolizumab in patients with severe eosinophilic asthma: Results of a single-centre observational study.
Mepolizumab is a humanized monoclonal antibody which targets interleukin-5 (IL-5) and is nowadays available in many countries for add-on biological therapy of severe eosinophilic asthma. Although the approval of mepolizumab use in clinical practice has been made possible by several successful pre-marketing controlled trials, so far only a very few studies have been performed in a real-life setting. Within such a context, our present observational investigation refers to 14 patients with refractory eosinophilic asthma, currently treated with mepolizumab at the Respiratory Unit of "Magna Græcia" University Hospital located in Catanzaro, Italy, whose anti-IL-5 treatment began between June 2017 and January 2018. ⋯ These changes were associated with significant and stable increases in FEV1, which was recorded at baseline (1389 ± 454.3 mL), as well as after 4 weeks (1711 ± 482.3 mL; p < 0.001) and 24 weeks (1701 ± 456.0 mL; p < 0.01). Moreover, in comparison to the 6 months preceding the beginning of treatment with mepolizumab, after 24 weeks of anti-IL-5 therapy significant decreases were detected with regard to exacerbation numbers (from 3.64 ± 1.86 to 1.0 ± 0.78; p < 0.001) and oral intake of prednisone (from 24.11 ± 10.36 mg/day to 1.78 ± 3.82 mg/day). Therefore, these preliminary data referring to our single-centre observational study corroborate, in a real-life environment, the efficacy of mepolizumab for treatment of patients with exacerbation-prone, corticosteroid-refractory, severe eosinophilic asthma.
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Pulm Pharmacol Ther · Dec 2018
Randomized Controlled Trial Comparative StudyPharmacokinetics and safety of a single dose of the novel LAMA/LABA fixed-dose combination of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler, formulated using co-suspension delivery technology, in Japanese healthy subjects.
Chronic obstructive pulmonary disease (COPD) causes significant mortality in Japan. GFF MDI is a long-acting muscarinic antagonist/long-acting β2-agonist fixed-dose combination of glycopyrronium (GP) and formoterol fumarate dihydrate (FF), delivered by a metered dose inhaler (MDI) using co-suspension delivery technology, for the long-term maintenance treatment of COPD. ⋯ The addition of FF 10 μg to GP MDI 28.8 μg or 14.4 μg in a fixed-dose combination did not appreciably alter the PK of GP, nor did an increase in GP dose from 14.4 μg to 28.8 μg in a fixed-dose combination with FF 10 μg appreciably alter the PK of formoterol. Both formulations of GFF MDI and GP MDI were well tolerated in healthy Japanese subjects. Data from this study support further evaluation of GFF MDI in Japanese patients with COPD.
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Pulm Pharmacol Ther · Dec 2018
ReviewBuilding reliable evidence from real-world data: Needs, methods, cautiousness and recommendations.
National healthcare systems of advanced countries, including Italy, widely agree on the approach whereby public healthcare decisions should be driven by available evidence on effectiveness and safety of therapeutics. It is equally accepted that randomized controlled clinical trials (RCTs), although universally recognised as the most robust "evidence generators", are insufficient for guiding the decision-making process since they are intrinsically unsuited to capture the impact of treatments in routine clinical practice. The complexity of treatments, as well as the demographic and clinical heterogeneity of patients receiving the treatments, and the long period of many treatments, explain the gap between the evidence generated in the controlled, but artificial, setting of RCTs and their current impact in the real world. ⋯ Among them, those based on the Electronic Healthcare Records (EHRs), as the databases on the healthcare services of the National Health System provided to beneficiaries, known as Healthcare Utilization Databases (HCU), are becoming established and receiving increasing attention from the scientific community and healthcare decision-makers. We described the research areas in which HCU databases may be particularly useful, jointly with strength, weakness and potential of this approach. It is concluded that HCU data cannot substitute RCTs but they can usefully complement RCT data for adequately supporting healthcare decision-makers.
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Pulm Pharmacol Ther · Oct 2018
Randomized Controlled TrialEffect of a spacer on total systemic and lung bioavailability in healthy volunteers and in vitro performance of the Symbicort® (budesonide/formoterol) pressurized metered dose inhaler.
Many patients with chronic obstructive pulmonary disease or asthma experience difficulties in coordinating inhalation with pressurized metered-dose inhaler (pMDI) actuation. The use of a spacer device can improve drug delivery in these patients. The aim of this study was to establish the relative bioavailability of single doses of Symbicort® (budesonide/formoterol) pMDI 160/4.5 μg/actuation (2 actuations) used with and without a spacer device. In addition, an in vitro study was conducted to characterize performance of the inhaler when used in conjunction with a spacer device. ⋯ The clinical study demonstrated that in subjects with poor inhalation technique the use of the AeroChamber Plus® Flow-Vu® spacer increased the bioavailability of Symbicort® pMDI to a level observed in subjects with good inhalation technique without a spacer. The findings from the in vitro study support the fine particle dose characteristics of Symbicort® pMDI with the AeroChamber Plus® Flow-Vu® spacer.
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Pulm Pharmacol Ther · Aug 2018
Mishandling of pMDI and DPI inhalers in asthma and COPD - Repetitive and non-repetitive errors.
Pharmacological treatment of asthma and chronic obstructive pulmonary disease (COPD) is based mainly on inhaled medications. There is a continuous need to examine and train patients in their inhalation technique. The objective of the presented study is to determine whether the errors which patients made during inhalations are repetitive, and therefore easier to eradicate, or rather accidental, hence require more attention and effort from the health care professionals. ⋯ Improper inhalation technique is very common and the majority of errors made in inhalation technique are repetitive. This emphasizes the role of an ongoing verification and training of a proper inhalation technique in all patients that are regularly treated with inhalers.