Publications
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Sonnappa S, McQueen B, Postma DS, et al., 2018, Extrafine versus fine inhaled corticosteroids in relation to asthma control: a systematic review and meta-analysis of observational real-life studies, The journal of allergy and clinical immunology. In practice, Vol: 6, Pages: 907-915.e7, ISSN: 2213-2198
BACKGROUND: The particle size of inhaled corticosteroids (ICSs) may affect airway drug deposition and effectiveness. OBJECTIVE: To compare the effectiveness of extrafine ICSs (mass median aerodynamic diameter, <2 μm) versus fine-particle ICSs administered as ICS monotherapy or ICS-long-acting β-agonist combination therapy by conducting a meta-analysis of observational real-life asthma studies to estimate the treatment effect of extrafine ICSs. METHODS: MEDLINE and EMBASE databases were reviewed for asthma observational comparative effectiveness studies from January 2004 to June 2016. Studies were included if they reported odds and relative risk ratios and met all inclusion criteria (Respiratory Effectiveness Group/European Academy of Allergy and Clinical Immunology quality standards, comparison of extrafine ICSs with same or different ICS molecule, ≥12-month follow-up). End-point data (asthma control, exacerbations, prescribed ICS dose) were pooled. Random-effects meta-analysis modeling was used. The study protocol is published in the PROSPERO register CRD42016039137. RESULTS: Seven studies with 33,453 subjects aged 5 to 80 years met eligibility criteria for inclusion. Six studies used extrafine beclometasone propionate and 1 study used both extrafine beclometasone propionate and extrafine ciclesonide as comparators with fine-particle ICSs. The overall odds of achieving asthma control were significantly higher for extrafine ICSs compared with fine-particle ICSs (odds ratio, 1.34; 95% CI, 1.22-1.46). Overall exacerbation rate ratios (0.84; 95% CI, 0.73-0.97) and ICS dose (weighted mean difference, -170 μg; 95% CI, -222 to -118 μg) were significantly lower for extrafine ICSs compared with fine-particle ICSs. CONCLUSIONS: This meta-analysis demonstrates that extrafine ICSs have significantly higher odds of achieving asthma control with lower exacerbation rates at significantly lower prescribed doses than fine-particle ICSs.
Dekhuijzen R, Lavorini F, Usmani OS, et al., 2018, Addressing the impact and unmet needs of nonadherence in asthma and chronic obstructive pulmonary disease: where do we go from here?, Journal of Allergy and Clinical Immunology: In Practice, Vol: 6, Pages: 785-793, ISSN: 2213-2198
Nonadherence to treatment, and its associated health and economic burden, is particularly problematic in asthma and chronic obstructive pulmonary disease management because of heterogeneous patient populations and the need for an inhaled route of drug administration. Symptom variability, comorbidities, and device switching further add to suboptimal adherence rates. As opposed to controlled clinical trials, real-life studies show consistently low inhaler adherence in daily practice, yet exact adherence rates have long been affected by disagreement on standardized definitions. The recently developed Ascertaining Barriers to Compliance taxonomy helps to address adherence research disparities by identifying 3 phases of adherence (initiation, implementation [including correct inhaler technique], and discontinuation). This review considers the reasons for and impact of suboptimal adherence, together with summaries of key studies that demonstrate how improving adherence can reduce exacerbations, inhaled corticosteroid use (in cases of better inhaler technique), hospitalizations, and treatment costs. Strategies to help ensure optimal adherence are discussed, including the choice of a patient-tailored inhaler, patient empowerment, education and training, and the potential of electronic monitoring and digital technology. It is concluded that a combined effort from payers, health care professionals, and manufacturers could make a real difference to asthma and chronic obstructive pulmonary disease control, as well as to health care budgets.
Hillyer EV, Price DB, Chrystyn H, et al., 2018, Harmonizing the nomenclature for therapeutic aerosol particle size: a proposal, Journal of Aerosol Medicine and Pulmonary Drug Delivery, Vol: 31, Pages: 111-113, ISSN: 1941-2703
Buttini F, Lavorini F, Bettini R, et al., 2018, THE GLOBAL INHALER EFFECTIVENESS SCORE (GIES): A NOVEL TOOL FOR ASSESSING AND RANKING <i>IN VITRO</i> PROPERTIES AND PATIENTS USABILITY OF DRY POWDER INHALERS. RATIONALE AND METHODOLOGY, Publisher: MARY ANN LIEBERT, INC, Pages: A25-A25, ISSN: 1941-2711
Bonini M, Usmani OS, 2018, Let research leave you breathless, not physical exercise!, ERJ Open Research, Vol: 4, ISSN: 2312-0541
Proper endotyping of EIB and precision medicine strategies would allow subjects to fully profit from the very beneficial effects of exercise, without incurring health risks or affecting performances http://ow.ly/spjT30irzjX.
Andersson C, Bonvini SJ, Horvath P, et al., 2018, Research highlights from the 2017 ERS International Congress: airway diseases in focus, ERJ Open Research, Vol: 4, ISSN: 2312-0541
For another year, high-quality research studies from around the world transformed the annual ERS International Congress into a vivid platform to discuss trending research topics, to produce new research questions and to further push the boundaries of respiratory medicine and science. This article reviews only some of the high-quality research studies on asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis and chronic cough that were presented during the congress through the Airway Diseases Assembly (ERS Assembly 5) and places them into the context of current knowledge and research challenges.
Maher TM, Biddiscombe M, Fahy WA, et al., 2018, The Topical Study Of Inhaled Drug (salbutamol) Delivery In Idiopathic Pulmonary Fibrosis, Respiratory Research, Vol: 19, ISSN: 1465-9921
BackgroundOur aim was to investigate total and regional lung delivery of salbutamol in subjects with idiopathic pulmonary fibrosis (IPF).MethodsThe TOPICAL study was a 4-period, partially-randomised, controlled, crossover study to investigate four aerosolised approaches in IPF subjects. Nine subjects were randomised to receive 99mTechnetium-labelled monodisperse salbutamol (1.5 μm or 6 μm; periods 1 and 2). Subjects also received radio-labelled salbutamol using a polydisperse nebuliser (period 3) and unlabelled salbutamol (400 μg) using a polydisperse pressurized metered dose inhaler with volumatic spacer (pMDI; period 4).ResultsSmall monodisperse particles (1.5 μm) achieved significantly better total lung deposition (TLD, mean % ± SD) than larger particles (6 μm), where polydisperse nebulisation was poor; (TLD, 64.93 ± 10.72; 50.46 ± 17.04; 8.19 ± 7.72, respectively). Small monodisperse particles (1.5 μm) achieved significantly better lung penetration (mean % ± SD) than larger particles (6 μm), and polydisperse nebulisation showed lung penetration similar to the small particles; PI (mean ± SD) 0.8 ± 0.16, 0.49 ± 0.21, and 0.73 ± 0.19, respectively. Higher dose-normalised plasma salbutamol levels were observed following monodisperse 1.5 μm and 6 μm particles, compared to polydisperse pMDI inhalation, while lowest plasma levels were observed following polydisperse nebulisation.ConclusionOur data is the first systematic investigation of inhaled drug delivery in fibrotic lung disease. We provide evidence that inhaled drugs can be optimised to reach the peripheral areas of the lung where active scarring occurs in IPF.
Usmani OS, Lavorini F, Marshall J, et al., 2018, Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes, Respiratory Research, Vol: 19, ISSN: 1465-9921
Background:Inhaled drug delivery is the cornerstone treatment for asthma and chronic obstructive pulmonary disease (COPD). However, use of inhaler devices can be challenging, potentially leading to critical errors in handling that can significantly reduce drug delivery to the lungs and effectiveness of treatment.Methods:A systematic review was conducted to define ‘critical’ errors and their impact on health outcomes and resource use between 2004 and 2016, using key search terms for inhaler errors in asthma and COPD (Search-1) and associated health-economic and patient burden (Search-2).Results:Search-1 identified 62 manuscripts, 47 abstracts, and 5 conference proceedings (n = 114 total). Search-2 identified 9 studies. We observed 299 descriptions of critical error. Age, education status, previous inhaler instruction, comorbidities and socioeconomic status were associated with worse handling error frequency. A significant association was found between inhaler errors and poor disease outcomes (exacerbations), and greater health-economic burden.Conclusions:We have shown wide variations in how critical errors are defined, and the evidence shows an important association between inhaler errors and worsened health outcomes. Given the negative impact diminished disease outcomes impose on resource use, our findings highlight the importance of achieving optimal inhaler technique, and a need for a consensus on defining critical and non-critical errors.
Hajian B, De Backer J, Vos W, et al., 2018, Changes in ventilation-perfusion during and after an COPD exacerbation: an assessment using fluid dynamic modeling, International Journal of Chronic Obstructive Pulmonary Disease, Vol: 13, Pages: 833-842, ISSN: 1176-9106
Introduction: Severe exacerbations associated with chronic obstructive pulmonary disease (COPD) that require hospitalization significantly contribute to morbidity and mortality. Definitions for exacerbations are very broad, and it is unclear whether there is one predominant underlying mechanism that leads to them. Functional respiratory imaging (FRI) with modeling provides detailed information about airway resistance, hyperinflation, and ventilation-perfusion (V/Q) mismatch during and following an acute exacerbation. Materials and methods: Forty-two patients with COPD participating in a multicenter study were assessed by FRI, pulmonary function tests, and self-reported outcome measures during an acute exacerbation and following resolution. Arterial blood gasses and lung function parameters were measured. Results: A significant correlation was found between alveolar-arterial gradient and image-based V/Q (iV/Q), suggesting that iV/Q represents V/Q mismatch during an exacerbation (p<0.05). Conclusion: Recovery of an exacerbation is due to decreased (mainly distal) airway resistance (p<0.05). Improvement in patient-reported outcomes were also associated with decreased distal airway resistance (p<0.05), but not with forced expiratory volume. FRI is, therefore, a sensitive tool to describe changes in airway caliber, ventilation, and perfusion during and after exacerbation. On the basis of the fact that FRI increased distal airway resistance seems to be the main cause of an exacerbation, therapy should mainly focus on decreasing it during and after the acute event.
Lalas A, Nousias S, Kikidis D, et al., 2017, Substance deposition assessment in obstructed pulmonary system through numerical characterization of airflow and inhaled particles attributes, BMC Medical Informatics and Decision Making, Vol: 17, ISSN: 1472-6947
BackgroundChronic obstructive pulmonary disease (COPD) and asthma are considered as the two most widespread obstructive lung diseases, whereas they affect more than 500 million people worldwide. Unfortunately, the requirement for detailed geometric models of the lungs in combination with the increased computational resources needed for the simulation of the breathing did not allow great progress to be made in the past for the better understanding of inflammatory diseases of the airways through detailed modelling approaches. In this context, computational fluid dynamics (CFD) simulations accompanied by fluid particle tracing (FPT) analysis of the inhaled ambient particles are deemed critical for lung function assessment. Also they enable the understanding of particle depositions on the airways of patients, since these accumulations may affect or lead to inflammations. In this direction, the current study conducts an initial investigation for the better comprehension of particle deposition within the lungs. More specifically, accurate models of the airways obstructions that relate to pulmonary disease are developed and a thorough assessment of the airflow behavior together with identification of the effects of inhaled particle properties, such as size and density, is conducted. Our approach presents a first step towards an effective personalization of pulmonary treatment in regards to the geometric characteristics of the lungs and the in depth understanding of airflows within the airways.MethodsA geometry processing technique involving contraction algorithms is established and used to employ the different respiratory arrangements associated with lung related diseases that exhibit airways obstructions. Apart from the normal lung case, two categories of obstructed cases are examined, i.e. models with obstructions in both lungs and models with narrowings in the right lung only. Precise assumptions regarding airflow and deposition fraction (DF) over various sections of th
Rastogi S, Bosnic-Antievich S, Pavord I, et al., 2017, FENO AND BLOOD EOSINOPHILS AS BIOMARKERS IN PREDICTING ASTHMA EXACERBATIONS, Winter Meeting of the British-Thoracic-Society, Publisher: BMJ PUBLISHING GROUP, Pages: A190-+, ISSN: 0040-6376
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Bonini M, Usmani O, Pacini A, et al., 2017, MARKED SMALL AIRWAY DYSFUNCTION AND CONSEQUENT AIR-TRAPPING CHARACTERISE CHRONIC HYPERSENSITIVITY PNEUMONITIS (CHP) BUT NOT IDIOPATHIC PULMONARY FIBROSIS (IPF), Winter Meeting of the British-Thoracic-Society, Publisher: BMJ PUBLISHING GROUP, Pages: A34-A35, ISSN: 0040-6376
Taylor G, Warren S, Dwivedi S, et al., 2017, Gamma scintigraphic pulmonary deposition study of glycopyrronium/formoterol metered dose inhaler formulated using co-suspension delivery technology, European Journal of Pharmaceutical Sciences, Vol: 111, Pages: 450-457, ISSN: 0928-0987
This gamma scintigraphy imaging study was the first to assess pulmonary and extrathoracic deposition and regional lung deposition patterns of a radiolabelled long-acting muscarinic antagonist/long-acting β2-agonist fixed-dose combination glycopyrronium/formoterol fumarate dihydrate (GFF) 14.4/10 μg (equivalent to glycopyrrolate/formoterol fumarate 18/9.6 μg), delivered by pressurized metered dose inhaler (pMDI) using novel co-suspension delivery technology. In this Phase I, randomized, single-centre, single-blind, single-dose, two-treatment, crossover, placebo-controlled study (PT003020), 10 healthy male adults received two actuations of GFF pMDI (7.2/5.0 μg per actuation) and placebo pMDI (containing phospholipid-based porous particles without active pharmaceutical ingredient), both radiolabelled with 99mTc, up to 5 MBq per actuation. Gamma scintigraphy images of lungs, stomach, head and neck were recorded. In addition, images of the actuators after use, collected mouth washings and exhalation filters were acquired. On average, 38.4% of the emitted dose of radiolabelled GFF pMDI, and 32.8% of radiolabelled placebo pMDI, was deposited in the lungs. The percentage emitted dose detected in the oropharyngeal and stomach regions was 61.4% and 66.9% for radiolabelled GFF pMDI and placebo pMDI, respectively. For both treatments, ≤ 0.25% of the emitted dose was detected in the exhalation filter. The normalized outer/inner ratio was 0.57 and 0.59 for radiolabelled GFF pMDI and placebo pMDI, respectively, and the standardized central/peripheral ratio was 1.85 and 1.94 respectively, indicating delivery of both co-suspension delivery technology formulations throughout the airways. There were no new or unexpected safety findings. In conclusion, both formulations were efficiently and uniformly deposited in the lungs with similar regional deposition patterns, oropharyngeal and stomach deposition, exhalation fraction and actuator-recovered dose.
Bonini M, Usmani OS, 2017, Novel methods for device and adherence monitoring in asthma., Current Opinion in Pulmonary Medicine, Vol: 24, Pages: 63-69, ISSN: 1070-5287
PURPOSE OF REVIEW: The article aims to provide an updated and evidence-based review of the innovative electronic health interventions to monitor and improve inhaler technique and adherence to recommended therapy in asthma. RECENT FINDINGS: Out of the 290 articles identified by the search strategy, 23 manuscripts fulfilled the review inclusion criteria. Included studies mainly addressed m-health, electronic reminders, telemedicine, and inhaler tracker interventions. Investigations were performed both in adults and children. Remarkably, the majority of studies were performed in the most recent years, showing a progressively increasing interest for this field. Existing findings appear to be of moderate-high quality. A significant number of papers, however, were published in scientific journals with a low impact factor (<2). Furthermore, extremely high heterogeneity was found in the considered study endpoints. Collected evidence supports a relevant role for e-health in monitoring and improving inhaler use and treatment adherence in asthma. The patients' acceptance and satisfaction towards assessed interventions were also found to be positive. SUMMARY: E-health represents a highly valuable tool for achieving optimal and personalized asthma management. Unanimously agreed and adopted standards for conducting trials and reporting results on e-health in asthma are however needed to fully understand its real added value.
Singh D, Corradi M, Spinola M, et al., 2017, Triple therapy in COPD: new evidence with the extrafine fixed combination of beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide, International Journal of Chronic Obstructive Pulmonary Disease, Vol: 12, Pages: 2917-2928, ISSN: 1176-9106
The goals of COPD therapy are to prevent and control symptoms, reduce the frequency and severity of exacerbations, and improve exercise tolerance. The triple combination therapy of inhaled corticosteroids (ICSs), long-acting beta2 agonists (LABAs), and long-acting muscarinic antagonists (LAMAs) has become an option for maintenance treatment of COPD and as a “step-up” therapy from single or double combination treatments. There is evidence that triple combination ICS/LABA/LAMA with different inhalers improves lung function, symptoms, and health status and reduces exacerbations. A new triple fixed-dose combination of extrafine beclomethasone dipropionate (100 µg/puff)/formoterol fumarate (6 µg/puff)/glycopyrronium bromide (12.5 µg/puff) has been developed as a hydrofluoroalkane pressurized metered dose inhaler. Two large pivotal studies showed that this extrafine fixed ICS/LABA/LAMA triple combination is superior to fixed ICS/LABA combined therapy and also superior to the LAMA tiotropium in terms of lung function and exacerbation prevention in COPD patients at risk of exacerbation. This review considers the new information provided by these clinical trials of extrafine triple therapy and the implications for the clinical management of COPD patients.
Usmani OS, Kemppinen A, Gardener E, et al., 2017, A randomized pragmatic trial of changing to and stepping down Fluticasone/formoterol in asthma, Journal of Allergy and Clinical Immunology: In Practice, Vol: 5, Pages: 1378-1387.e5, ISSN: 2213-2198
BACKGROUND: Guidelines recommend reducing treatment in patients with well-controlled asthma after 3 months of stability. However, there is inadequate real-life data to guide physicians on therapy change in daily practice. OBJECTIVE: To assess asthma control after change to and step-down of fluticasone propionate/formoterol fumarate dihydrate (FP/FOR) in real-life patients. METHODS: In a randomized controlled, pragmatic, open-label trial, 225 well-controlled patients with asthma were randomized (1:2) to maintain high-dose fluticasone propionate/salmeterol xinafoate (FP/SAL, 1000/100 μg) or switch to FP/FOR (1000/40 μg) daily for 12 weeks (phase 1). One hundred sixteen patients stable on FP/FOR at week 12 were subsequently randomized (1:1) to maintain this therapy, or stepped down to FP/FOR (500/20 μg) daily for 12 weeks (phase 2). The primary end point was the 7-question Asthma Control Questionnaire (ACQ7) score. RESULTS: In phase 1, FP/FOR (1000/40 μg) (n = 126) was noninferior to FP/SAL (1000/100 μg) (n = 73) for ACQ7 (difference in means, -0.12; 95% CI, -0.32 to 0.09). In phase 2, FP/FOR (500/20 μg) (n = 52) was noninferior to FP/FOR (1000/40 μg) (n = 52) for ACQ7 (difference in means, 0.01; 95% CI, -0.20 to 0.22). There was no significant difference in exacerbation rate between the groups in either phase. However, 1 to 2 exacerbations in 12 months before phase 1 were associated with the occurrence of an exacerbation after step-down (P = .007). CONCLUSIONS: In patients with well-controlled asthma, a change from FP/SAL to FP/FOR did not compromise asthma control. Step-down of FP/FOR was well tolerated; however, in contrast to current guidelines, our data suggest caution in stepping down patients uncontrolled in the last 12 months. Larger step-down studies are required to confirm these findings.
Bonini M, Menichini I, Pacini A, et al., 2017, Small airways impairment and air-trapping in patients with chronic hypersensitivity pneumonitis (CHP) of different severity, European-Respiratory-Society (ERS) International Congress, Publisher: EUROPEAN RESPIRATORY SOC JOURNALS LTD, ISSN: 0903-1936
Bonini M, Pacini A, Menichini I, et al., 2017, Small airways impairment and air-trapping distinguish chronic hypersensitivity pneumonitis (CHP) from idiopathic pulmonary fibrosis (IPF), European-Respiratory-Society (ERS) International Congress, Publisher: EUROPEAN RESPIRATORY SOC JOURNALS LTD, ISSN: 0903-1936
Kocsis O, Arvanitis G, Lalos A, et al., 2017, Assessing Machine Learning Algorithms for Self-Management of Asthma, 6th IEEE International Conference on E-Health and Bioengineering (EHB), Publisher: IEEE, Pages: 571-574, ISSN: 2575-5137
Lavorini F, Pistolesi M, Usmani OS, 2017, Erratum: Recent advances in capsule-based dry powder inhaler technology (vol 12, 11, 2017), Multidisciplinary Respiratory Medicine, Vol: 12, ISSN: 2049-6958
Sonnappa S, Martin R, Israel E, et al., 2017, Risk of pneumonia in obstructive lung disease: A real-life study comparing extra-fine and fine-particle inhaled corticosteroids, PLOS ONE, Vol: 12, ISSN: 1932-6203
Background:Regular use of inhaled corticosteroids (ICS) in patients with obstructive lung diseases has been associated with a higher risk of pneumonia, particularly in COPD. The risk of pneumonia has not been previously evaluated in relation to ICS particle size and dose used.Methods:Historical cohort, UK database study of 23,013 patients with obstructive lung disease aged 12–80 years prescribed extra-fine or fine-particle ICS. The endpoints assessed during the outcome year were diagnosis of pneumonia, acute exacerbations and acute respiratory events in relation to ICS dose. To determine the association between ICS particle size, dose and risk of pneumonia in unmatched and matched treatment groups, logistic and conditional logistic regression models were used.Results:14788 patients were stepped-up to fine-particle ICS and 8225 to extra-fine ICS. On unmatched analysis, patients stepping-up to extra-fine ICS were significantly less likely to be coded for pneumonia (adjusted odds ratio [aOR] 0.60; 95% CI 0.37, 0.97]); experience acute exacerbations (adjusted risk ratio [aRR] 0.91; 95%CI 0.85, 0.97); and acute respiratory events (aRR 0.90; 95%CI 0.86, 0.94) compared with patients stepping-up to fine-particle ICS. Patients prescribed daily ICS doses in excess of 700 mcg (fluticasone propionate equivalent) had a significantly higher risk of pneumonia (OR [95%CI] 2.38 [1.17, 4.83]) compared with patients prescribed lower doses, irrespective of particle size.Conclusions:These findings suggest that patients with obstructive lung disease on extra-fine particle ICS have a lower risk of pneumonia than those on fine-particle ICS, with those receiving higher ICS doses being at a greater risk.
Lavorini F, Pistolesi M, Usmani OS, 2017, Recent advances in capsule-based dry powder inhaler technology, Multidisciplinary Respiratory Medicine, Vol: 12, ISSN: 2049-6958
Pulmonary drug delivery is currently the focus of accelerated research and development because of the potential to produce maximum therapeutic benefit to patients by directly targeting drug to the site of pathology in the lungs. Among the available delivery options, the dry powder inhaler (DPI) is the preferred device for the treatment of an increasingly diverse range of diseases. However, because drug delivery from a DPI involves a complex interaction between the device and the patient, the engineering development of this medical technology is proving to be a great challenge. Development of DPI systems that target the delivery of fine drug particles to the deeper airways in the lungs using a combination of improved drug formulations and enhanced delivery device technologies means that each of these factors contributes to overall performance of the aerosol system. There are a large range of devices that are currently available, or under development, for clinical use, however no individual device shows superior clinical efficacy. A major concern that is very relevant in day-to-day clinical practice is the inter- and intra-patient variability of the drug dosage delivered to the deep lungs from the inhalation devices, where the extent of variability depends on the drug formulation, the device design, and the patient’s inhalation profile. This variability may result in under-dosing of drug to the patient and potential loss of pharmacological efficacy. This article reviews recent advances in capsule-based DPI technology and the introduction of the ‘disposable’ DPI device.
Wang K, Milojevic N, Sheinman B, et al., 2017, Cough management in primary, secondary and tertiary settings, Pulmonary Pharmacology & Therapeutics, Vol: 47, Pages: 93-98, ISSN: 1522-9629
This review reflects upon the management of cough in primary, secondary and tertiary care settings. It reviews the burden of cough, the diagnostic tools employed to investigate the cause of cough and pragmatic treatment strategies. A clinical case vignette presenting in primary care highlights the challenges of managing cough by family practitioners. An approach to establishing a persistent cough clinic service in secondary care is described. Finally, the entity of idiopathic cough in tertiary care and the specialist approaches to treating recalcitrant cough are addressed.
Simpson AJ, Honkoop PJ, Kennington E, et al., 2017, Perspectives of patients and healthcare professionals on mHealth for asthma self-management, EUROPEAN RESPIRATORY JOURNAL, Vol: 49, ISSN: 0903-1936
Mobile healthcare (mHealth) has the potential to revolutionise the self-management of long-term medical conditions such as asthma. A user-centred design is integral if mHealth is to be embraced by patients and healthcare professionals.The aim of this study was to determine the perspectives of individuals with asthma and healthcare professionals on the use of mHealth for asthma self-management.We used a sequential exploratory mixed methods design; focus groups informed the development of questionnaires, which were disseminated to individuals with asthma and healthcare professionals.Focus group participants (18 asthma patients and five healthcare professionals) identified 12 potential uses of mHealth. Questionnaire results showed that individuals with asthma (n=186) most frequently requested an mHealth system to monitor asthma over time (72%) and to collect data to present to healthcare teams (70%). In contrast, healthcare professionals (n=63) most frequently selected a system alerting patients to deteriorating asthma control (86%) and advising them when to seek medical attention (87%). Individuals with asthma were less likely than healthcare professionals (p<0.001) to believe that assessing medication adherence and inhaler technique could improve asthma control.Our data provide strong support for mHealth for asthma self-management, but highlight fundamental differences between the perspectives of patients and healthcare professionals.
Usmani OS, Molimard M, Gaur V, et al., 2017, Scientific Rationale for Determining the Bioequivalence of Inhaled Drugs., Clinical Pharmacokinetics, Vol: 56, Pages: 1139-1154, ISSN: 0312-5963
In recent years, pathways for the development and approval of bioequivalent inhaled products have been established for regulated markets, including the European Union (EU), and a number of orally inhaled products (OIPs) have been approved in the EU solely on the basis of in vitro and pharmacokinetic data. This review describes how these development pathways are structured and their implications for the treatment of airway diseases such as asthma. The EU guidance follows a stepwise approach that includes in vitro criteria as the first step. If all in vitro criteria are not met, the second step is based on pharmacokinetic evaluations, which include assessments of lung and systemic bioavailability. If all pharmacokinetic criteria are not met, the third step is based on clinical endpoint studies. In this review, the scientific rationale of the European Medicines Agency guidance for the development of bioequivalent OIPs is reviewed with the focus on the development of bioequivalent OIPs in the EU. Indeed, we discuss the advantages and disadvantages of the weight-of-evidence and stepwise approaches. The evidence indicates that the EU guidance is robust and, unlike clinical endpoint studies, the pharmacokinetic studies are far more sensitive to measure the minor differences, i.e. deposition and absorption rates, in drug delivery from the test and reference products and, thus, should be best suited for assessing bioequivalence. The acceptance range of the 90% confidence intervals for pharmacokinetic bioequivalence (i.e. 80-125% for both the area under the plasma concentration-time curve and maximum plasma concentration) represent appropriately conservative margins for ensuring equivalent safety and efficacy of the test and reference products.
Scichilone N, Braido F, Lavorini F, et al., 2017, Routine Use of Budesonide/Formoterol Fixed Dose Combination in Elderly Asthmatic Patients: Practical Considerations, DRUGS & AGING, Vol: 34, Pages: 321-330, ISSN: 1170-229X
Asthma has been demonstrated to be as common in the elderly as in younger age groups. Although no specific recommendations exist to manage the disease differently in older individuals, functional features and clinical presentations may be affected by age per se, and by age-related conditions, such as comorbidities and polypharmacy. In this review article, we aimed to explore the efficacy and safety in elderly asthmatic patients of one of the most currently used inhaled treatments for asthma, that is, the fixed-dose combination of budesonide/formoterol. We attempted to address some practical questions that are relevant to the daily practice of clinicians. We focused on the efficacy and real-world effectiveness of inhaled corticosteroids and long-acting β-adrenergic bronchodilators (ICS/LABA) as treatment in the elderly population, since data are extrapolated from younger populations. We investigated whether a maintenance and reliever therapy approach is more effective in the elderly as opposed to maintenance regimens, from both the general practitioner’s and the pulmonologist’s perspective. To address these questions, we scanned electronic databases (PubMed, MEDLINE, Embase, Scopus and Google Scholar) from the date of inception up to October 2016 with a cross-search using the following keywords: ‘asthma’, ‘elderly’, ‘SMART therapy’, ‘MART therapy’, ‘Turbuhaler’, and ‘budesonide/formoterol’. The available literature on the topic confirms that when the age-associated changes are properly managed in clinical practice, asthma in older populations can be optimally controlled with inhaled treatment including ICS/LABA. This also applies for the budesonide/formoterol fixed combination, thus allowing for the maintenance and reliever therapy approach.
Pignataro FS, Bonini M, Forgione A, et al., 2017, Asthma and gender: the female lung, Pharmacological Research, Vol: 119, Pages: 384-390, ISSN: 1043-6618
Asthma is a common chronic disease that affects over 300 million people worldwide, resulting in a considerable socio-economic burden.Literature data suggest that asthma has a higher incidence in females, particularly at certain stages of pubertal development. Moreover, women seem to experience more asthma symptoms than men and to use more rescue medications, resulting in a reduced quality of life.Although several mechanisms have been proposed to explain these differences, there are not yet final data available in the literature on the role of gender in the pathogenesis of asthma and different behavior in females.Some study suggested a more prevalent hyper-responsiveness in women than in men. Nevertheless, in the literature definitive data on a possible different response to drugs used for asthma between males and females are not described.Understanding the mechanisms that underlie these gender differences in clinical history of asthma patients could give inspiration to new areas of research to obtain a more specific diagnostic and therapeutic approach gender-oriented.
Honkoop PJ, Simpson A, Bonini M, et al., 2017, MyAirCoach: the use of home-monitoring and mHealth systems to predict deterioration in asthma control and the occurrence of asthma exacerbations; study protocol of an observational study., BMJ Open, Vol: 7, ISSN: 2044-6055
INTRODUCTION: Asthma is a variable lung condition whereby patients experience periods of controlled and uncontrolled asthma symptoms. Patients who experience prolonged periods of uncontrolled asthma have a higher incidence of exacerbations and increased morbidity and mortality rates. The ability to determine and to predict levels of asthma control and the occurrence of exacerbations is crucial in asthma management. Therefore, we aimed to determine to what extent physiological, behavioural and environmental data, obtained by mobile healthcare (mHealth) and home-monitoring sensors, as well as patient characteristics, can be used to predict episodes of uncontrolled asthma and the onset of asthma exacerbations. METHODS AND ANALYSIS: In an 1-year observational study, patients will be provided with mHealth and home-monitoring systems to record daily measurements for the first-month (phase I) and weekly measurements during a follow-up period of 11 months (phase II). Our study population consists of 150 patients, aged ≥18 years, with a clinician's diagnosis of asthma, currently on controller medication, with uncontrolled asthma and/or minimally one exacerbation in the past 12 months. They will be enrolled over three participating centres, including Leiden, London and Manchester. Our main outcomes are the association between physiological, behavioural and environmental data and (1) the loss of asthma control and (2) the occurrence of asthma exacerbations. ETHICS: This study was approved by the Medical Ethics Committee of the Leiden University Medical Center in the Netherlands and by the NHS ethics service in the UK. TRIAL REGISTRATION NUMBER: NCT02774772.
Lalas A, Kikidis D, Votis K, et al., 2017, Numerical assessment of airflow and inhaled particles attributes in obstructed pulmonary system, IEEE International Conference on Bioinformatics and Biomedicine (IEEE BIBM), Publisher: IEEE, Pages: 606-612, ISSN: 2156-1125
Geometry contraction algorithms are introduced in this work to implement the diverse respiratory configurations of lung related diseases associated with airways obstructions. In addition, computational fluid dynamics (CFD) techniques along with fluid particle tracing (FPT) methods are utilized to efficiently evaluate the behavior of the airflow during the inhalation period, as well as to clarify the features of the inhaled particles in terms of regional deposition. Useful deductions are drawn regarding personalized medication in obstructed conditions.
Lavorini F, Pistolesi M, Usmani OS, 2017, Erratum: Recent advances in capsulebased dry powder inhaler technology (Multidisciplinary Respiratory Medicine (2017) 12 (11) DOI: 10.1186/s40248-017-0092-5), Multidisciplinary Respiratory Medicine, Vol: 12, ISSN: 1828-695X
After publication of the article [1] it was brought to our attention that resistance values of Breezahler (0.15 cmH2O/ L/min) and Handihaler (0.22 cmH2O/L/min) are incorrect. (page 4 right column, lines 14 and 16 from below). The correct resistance values of Breezhaler and Handihaler are 0.07 and 0.16 cmH2O/L.min-1, respectively. We apologise for the inaccuracy.
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