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Supplemental material, Reviewer_1_v.1 for What to consider before prescribing inhaled medications: a pragmatic approach for evaluating the current inhaler landscape by Federico Lavorini, Christer Janson, Fulvio Braido, Georgios Stratelis and Anders Løkke in Therapeutic Advances in Respiratory Disease

Supplemental material, Reviewer_2_v.1 for What to consider before prescribing inhaled medications: a pragmatic approach for evaluating the current inhaler landscape by Federico Lavorini, Christer Janson, Fulvio Braido, Georgios Stratelis and Anders Løkke in Therapeutic Advances in Respiratory Disease

Supplemental material, Supplemental_material for What to consider before prescribing inhaled medications: a pragmatic approach for evaluating the current inhaler landscape by Federico Lavorini, Christer Janson, Fulvio Braido, Georgios Stratelis and Anders Løkke in Therapeutic Advances in Respiratory Disease

Supplemental material, Author_Response_1 for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study by Marco Contoli, Paola Rogliani, Fabiano Di Marco, Fulvio Braido, Angelo G. Corsico, Christian A. Amici, Roberto Piro, Riccardo Sarzani, Patrizia Lessi, Carla Scognamillo, Nicola Scichilone and Pierachille Santus in Therapeutic Advances in Respiratory Disease

Supplemental material, Reviewer_2_v.1 for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study by Marco Contoli, Paola Rogliani, Fabiano Di Marco, Fulvio Braido, Angelo G. Corsico, Christian A. Amici, Roberto Piro, Riccardo Sarzani, Patrizia Lessi, Carla Scognamillo, Nicola Scichilone and Pierachille Santus in Therapeutic Advances in Respiratory Disease

Supplemental material, Supplemental_material for What to consider before prescribing inhaled medications: a pragmatic approach for evaluating the current inhaler landscape by Federico Lavorini, Christer Janson, Fulvio Braido, Georgios Stratelis and Anders Løkke in Therapeutic Advances in Respiratory Disease

Supplemental material, Contoli_et_al_Additional_file20190924 for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study by Marco Contoli, Paola Rogliani, Fabiano Di Marco, Fulvio Braido, Angelo G. Corsico, Christian A. Amici, Roberto Piro, Riccardo Sarzani, Patrizia Lessi, Carla Scognamillo, Nicola Scichilone and Pierachille Santus in Therapeutic Advances in Respiratory Disease

Supplemental material, Reviewer_3_v.1 for What to consider before prescribing inhaled medications: a pragmatic approach for evaluating the current inhaler landscape by Federico Lavorini, Christer Janson, Fulvio Braido, Georgios Stratelis and Anders Løkke in Therapeutic Advances in Respiratory Disease

Supplemental material, Reviewer_1_v.1 for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study by Marco Contoli, Paola Rogliani, Fabiano Di Marco, Fulvio Braido, Angelo G. Corsico, Christian A. Amici, Roberto Piro, Riccardo Sarzani, Patrizia Lessi, Carla Scognamillo, Nicola Scichilone and Pierachille Santus in Therapeutic Advances in Respiratory Disease

The treatment of acute respiratory failure with non-invasive ventilation (NIV) as a first-line therapy is increasingly common in intensive care units. The reduced invasiveness of NIV leads to better outcomes than endotracheal intubation in carefully selected groups of patients. Furthermore, the use of NIV as a palliative treatment for respiratory failure and dyspnea has become increasingly common. NIV also has an impact on the use of "do not intubate" orders. In the present narrative review, we explore the use and outcome of NIV in elderly patients. To accomplish this, we reviewed the most recent available medical literature. Geriatr Gerontol Int 2017; 17: 689-696.

Scatter plot of ACQ and miniAQLQ scores. Table S1. Characteristics of asthma. Table S2. Lung function. Table S3. Propensity to adhere to therapy. Table S4. Healthcare resources consumption. Table S5. Healthcare and economic resources consumption by country. (DOCX 155 kb)

Background According to the Global Initiative of Asthma, the aim of asthma treatment is to gain and maintain control. In the INTERNATIONAL CROSS-SECTIONAL AND LONGITUDINAL ASSESSMENT ON ASTHMA CONTROL (LIAISON) study, we evaluated the level of asthma control and quality of life (QoL), as well as their determinants and impact in a population consulting specialist settings. Methods LIAISON is a prospective, multicentre, observational study with a cross-sectional and a 12-month longitudinal phase. Adults with an asthma diagnosis since at least 6 months, receiving the same asthma treatment in the 4 weeks before enrolment were included. Asthma control was assessed with the 6-item Asthma Control Questionnaire (ACQ) and QoL with the MiniAsthma Quality of Life Questionnaire (MiniAQLQ). Results Overall, 8111 asthmatic patients were enrolled in 12 European countries. Asthma control was suboptimal in 56.5 % of patients and it was associated with poorer asthma-related QoL, higher risk of exacerbations and greater consumption of healthcare resources. Variables associated with suboptimal control were age, gender, obesity, smoking and comorbidities. Major determinants of poor asthma control were seasonal worsening and persisting exposure to allergens/irritants/triggers, followed by treatment-related issues. Conclusions The cross-sectional phase results confirm that suboptimal control is frequent and has a high individual and economic impact. Trial registration The clinicaltrials.gov identifier is NCT01567280. Electronic supplementary material The online version of this article (doi:10.1186/s12931-016-0374-z) contains supplementary material, which is available to authorized users.

Allergic rhinitis, especially when persistent (PER) and associated with asthma heavily impairs patients' quality of life (QoL).This study assessed the effect of mometasone furoate nasal spray (MFNS) on the QoL of patients with PER and asthma, using the Rhinasthma questionnaire (EUDRACT n. 2007-004683-45).Patients with moderate/severe PER and intermittent asthma were randomized to MFNS (alcohol-free) 200 μg/day or placebo for 28 days. Rhinasthma was completed at baseline and at weeks 2 and 4. The total five symptom score (T5SS) for rhinitis, the asthma symptom score and the sum of the two [global symptoms score (GSS)] were recorded daily. The primary outcome was the change in the Rhinasthma global summary (GS) at the end of treatment. Secondary end-points were (a) the change from baseline to end of treatment of each Rhinasthma factor: upper airways (UAs), lower airways (LAs) and respiratory allergy impact; (b) the change from baseline to end of treatment of the T5SS and of the GSS and (c) the use of rescue medication.Fifty-two adults were randomized. Compared with placebo, MFNS produced a significant change in the Rhinasthma GS (-10.4 vs. 0.4; P0.01). MFNS also achieved a significant improvement of the UA (-16.6 vs. 0.1; P0.001), LA (-10.8 vs. 1.1; P0.001) and GSS (-6.7 vs. -3.1; P=0.019). The change of the T5SS was greater in the MFNS group but did not reach statistical significance.In patients with PER rhinitis and intermittent asthma, MFNS improves the QoL and the burden of respiratory symptoms. Treating rhinitis may affect the asthma-related QoL.

Despite the high and increasing prevalence of allergic diseases in athletes, allergy diagnostics is not part of the routine medical examination in sports medicine. This study reports the development and validation of an easy and reliable questionnaire for screening allergy in athletes.AQUA was derived from the European Community Respiratory Health Survey Questionnaire. On the basis of open interviews with team doctors, coaches, and athletes, questions were added about: the type, duration, and intensity of training; exercise-related allergic and infectious symptoms; social habits (smoking); drug and food supplements intake; antidoping regulations. The final version of the questionnaire, made of 25 selected questions, was validated in 128 professional soccer players who underwent accurate history taking, medical examination, skin prick testing, and/or specific IgE determination. On the basis of the correlation with objective allergy (positive skin tests to at least one allergen), questions were scored from 1 to 5 according to their positive likelihood ratio.Skin tests (gold standard for validation) were positive in 46.8% of soccer players. Mean total AQUA score was 9.4 +/- 7.8 in allergic athletes versus 1.3 +/- 2.3 in nonallergic athletes. A total AQUA score ofor=5 was shown to have the best positive predictive value for allergy (0.94) with a specificity of 97.1% and a sensitivity of 58.3%.AQUA, produced in 10 European languages, is a validated, easy, and reliable tool for calling attention on the high prevalence of allergy in athletes.

Chronic urticaria (CU) also known as chronic idiopathic urticaria results in a lowered quality of life (QoL). Disease specific questionnaires are necessary to assess QoL in CU patients. Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) is the only available and validated disease specific questionnaire in the assessment of QoL in CU patients originally developed in Italian language. The aim of the current study was to develop the Persian version of the CU-Q2oL with an acceptable reliability and validity. Using the standard methods provided by guidelines, CU-Q2oL was translated into Persian. A total number of 110 patients with confirmed diagnosis of CU were asked to fill the questionnaire. Determination of scales was performed in addition to checking the data for internal consistency and known group validity. Urticaria activity score 7 (UAS-7) was used to assess the severity of the CU in the population study. The 6 dimensional scale of Persian CU-Q2oL was determined using the Exploratory Factor Analysis. About 68% of the variance was explained by these 6 factor structure higher than 59.9% of the original Italian version. All 6 factors showed acceptable internal consistency as measured by Cronbach α coefficient. There was a significant correlation between UAS-7 and total CU-Q2oL score. UAS7 and the presence of angioedema were predictors of CU-Q2oL score. The Persian version of CU-Q2oL was shown to be a valid and reliable tool to be used in the future clinical studies. Cultural considerations must be kept in mind in adoption of CU-Q2oL to other languages.

Background Chronic obstructive pulmonary disease (COPD) is a heterogeneous disorder characterized by usually progressive development of airflow obstruction that is not fully reversible. While most patients will experience symptoms throughout the day or in the morning upon awakening, many patients do not experience their symptoms as constant but report variability in symptoms during the course of the day or over time. Symptom variability adversely affects patients' health status and increases the risk of COPD exacerbations. Methods We examined data from the literature on symptom variability and control in patients with COPD, with focus on the use of inhaled bronchodilator therapy with long-acting muscarinic antagonist agents (LAMA) plus long-acting β 2 -agonists (LABA); in particular twice-daily fixed-dose combination LAMA/LABA therapy with aclidinium/formoterol. Results Correct diagnosis and assessment of COPD requires comprehensive clinical and functional evaluation and consideration of individual needs to support the clinical decisions necessary for effective long-term management. Combining bronchodilators from different and complementary pharmacological classes with distinct mechanisms of action can increase the magnitude of bronchodilation as opposed to increasing the dose of a single bronchodilator. Conclusions The use of inhaled bronchodilator therapy with LAMA/LABA fixed-dose combinations in patients with stable COPD is supported by current evidence. This treatment approach provides robust effects on lung function and symptom control and may improve patients' adherence to treatment. Administration of the long-acting bronchodilators aclidinium and formoterol as twice daily fixed-dose aclidinium/formoterol 400/12 μg has the potential to control symptoms throughout the 24 h in patients with stable moderate-to-severe COPD.

Marco Contoli,1 Paolo Solidoro,2 Fabiano Di Marco,3,4 Nicola Scichilone,5 Angelo Corsico,6 Fulvio Braido,7 Pierachille Santus4,8 1Research Centre on Asthma and COPD, Department of Medical Sciences, University of Ferrara, Ferrara, Italy; 2Cardiovascular and Thoracic Department, Città della Salute, Turin, Italy; 3Department of Health Sciences, University of Milan, Milan, Italy; 4Respiratory Unit, San Paolo Hospital, Milan, Italy; 5Department of Internal Medicine, Section of Pulmonology (DIBIMIS), University of Palermo, Palermo, Italy; 6Department of Molecular Medicine, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; 7Allergy and Respiratory Diseases Clinic, DIMI, University of Genoa, IRCS AOU San Martino-IST, Genoa, Italy; 8Pulmonary Rehabilitation Unit, Fondazione Salvatore Maugeri, Scientific Institute of Milan-IRCCS, Milan, Italy Abstract: The pathophysiology of chronic obstructive pulmonary disease (COPD) includes persistent airflow limitation, altered gas exchange, and enhanced chronic inflammatory response. According to disease severity in individual patients, exacerbations and comorbidities frequently occur. The overall nocturnal and daily symptoms have a strong impact on patient quality of life and clinical outcomes. Bronchodilators, by targeting two important aspects of COPD pathophysiology, ie, bronchoconstriction and lung hyperinflation, are the mainstay of therapy for COPD. Aclidinium bromide in particular is an anticholinergic molecule, approved for maintenance bronchodilator treatment of stable COPD, that combines high antimuscarinic activity with strong kinetic selectivity for the M3 receptor subtype. Moreover, the elevated plasma clearance of aclidinium has been related to low systemic bioavailability and low incidence of anticholinergic adverse events, whereas the reduced residence time at M2 receptors provides good cardiovascular safety. Altogether, these characteristics result in a high safety and tolerability profile. This review aims to reappraise the contribution of symptoms and of the level of quality of life determinants on COPD severity and to evaluate how therapeutic strategies with aclidinium may positively impact on these specific determinants of disease severity. Keywords: COPD, quality of life, daily symptoms, LAMA, aclidinium

Proper use of inhaler devices may be problematic in elderly patients due to age-related difficulties. A survey was administered to elderly patients to investigate the usability of the Genuair® device and patients' subjective viewpoint on the device. A representative sample of the Italian population aged ≥ 65 years was completed with a pre-defined sample of 89 patients with hand arthritis/arthrosis. Of 526 respondents, 88 were not self-sufficient. Only the replies of the 438 self-sufficient respondents were analyzed. A total of 107 participants (24%) reported having respiratory diseases, and 81 of these (76%) were users of inhaler devices. After the first test, the device was considered “practical/handy” by 90% of patients and “easy to use” by 89%. After the second test, in which patients received a demonstration of the correct inhalation maneuver, the percentage of patients scoring ≥ 7 increased to 93% for the first characteristic and was confirmed for the second, with no differences between the groups in terms of age, educational level, use of devices, and presence of arthritis/arthrosis. The mean time to explain the inhaler technique and to perform a correct inhalation was 1'38"± 1'37", and 70% of the respondents required less than 2 minutes, with no differences between the groups in terms of age, education level, use of devices, and presence of arthritis/arthrosis. In conclusion, Genuair® was well accepted and easy to use in a representative sample of the Italian population aged ≥ 65 years. These characteristics make it a valid choice in the elderly, thus enabling patients to better cope with the problems and difficulties that are common to this age group.

Approximately 5%-10% of asthmatics suffer from severe asthma. New biological treatments represent a great opportunity to reduce asthma burden and to improve asthma patients' lives. Reslizumab will soon be available in several European countries. This anti-IL-5 IgG4/kappa monoclonal antibody, administered intravenously at a dose of 3 mg/kg over 20-50 minutes every 4 weeks, has been shown to be safe and effective in patients with 400 eosinophils/mu L or more in their peripheral blood. The clinical effects in reducing asthma exacerbations and in improving the quality of life and lung function are clear, but further research is needed to determine the best biological compound for a specific cluster of patients. Research data have shown that in patients who were expressing other clinical features of eosinophilic inflammation over asthma (rhinosinusitis and nasal polyposis), the clinical benefit of reslizumab was greater. Furthermore, it has also been observed that in patients with unsatisfactory response to mepolizumab, reslizumab is able to significantly improve the clinical and biological parameters. The aim of personalized medicine is to provide the right drug to the right patient at the right dose at the right moment. The biological treatments that were developed to modify specific pathological pathways not only provide us with the tools for the management of asthma patients but also clarify the biological mechanisms involved in its pathogenesis.

Background Asthma considerably impairs patients' quality of life and increases healthcare costs. Severity, morbidity, and degree of disease control are the major drivers of its clinical and economic impact. National scientific societies are required to monitor the application of international guidelines and to adopt strategies to improve disease control and better allocate resources. Aim to provide a detailed picture of the characteristics of asthma patients and modalities of asthma management by specialists in Italy and to develop recommendations for the daily management of asthma in a specialist setting. Method: A quantitative research program was implemented. Data were collected using an ad hoc questionnaire developed by a group of specialists selected by the Italian Pneumology Society/Italian Respiratory Society. Results The records of 557 patients were analyzed. In the next few years, specialists are expected to focus their activity patients with more severe disease and will be responsible for selection of patients for personalized biological therapy; however, only 20% of patients attending Italian specialist surgery can be considered severe. In 84.4% of cases, the visit was a follow-up visit requested in 82.2% of cases by the specialist him/herself. The Asthma Control Test is used only in 65% of patients. When available, a significant association has been observed between the test score and asthma control as judged by the physician, although concordance was only moderate (κ = 0.68). Asthma was considered uncontrolled by the specialist managing the case in 29.1% of patients; nevertheless, treatment was not stepped up in uncontrolled or partly controlled patients (modified in only 37.2% of patients). Conclusions The results of this survey support re-evaluation of asthma management by Italian specialists. More resources should be made available for the initial visit and for more severely ill patients. In addition, more extensive use should be made of validated tools, and available drugs should be used more appropriately.

Inhalation is the preferred route of drug administration in chronic respiratory diseases because it optimises delivery of the active compounds to the targeted site and minimises side effects from systemic distribution. The choice of a device should be made after careful evaluation of the patient's clinical condition (degree of airway obstruction, comorbidities), as well as their ability to coordinate the inhalation manoeuvre and to generate sufficient inspiratory flow. These patient factors must be aligned with the specific advantages and limitations of each inhaler when making this important choice. Finally, adherence to treatment is not the responsibility of the patient alone, but should be shared also by clinicians. Clinicians have access to a wide selection of pressurised metered dose inhalers (pMDIs) and dry powder inhalers (DPIs) that can be used effectively when matched to the needs of individual patients; this should be perceived as an opportunity rather than a limitation.