Mepolizumab effectiveness on small airway obstruction, corticosteroid sparing and maintenance therapy step-down in real life

Background: Mepolizumab (MEP) has been recently introduced to treat severe eosinophilic asthma. Trials have demonstrated a significant effectiveness in this asthma phenotype. We evaluated MEP efficacy on lung function, symptoms, asthma exacerbations, biologic markers, steroid dependence and controller treatment level in real-life. Methods: We retrospectively analyzed 134 severe asthmatics (61 males; mean age 58.3 ± 11; mean FEV1%:72 ± 21), treated with MEP for at least 6 months (mean duration:10.9 ± 3.7 months). Results: FEV1% improved significantly after MEP. Mean FEF25-75 also increased from 37.4 ± 25.4% to 47.2 ± 27.2% (p < 0.0001). Mean baseline blood eosinophil level was 712 ± 731/μ…

Author_Response_1 – Supplemental material for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study

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

Day and Night Control of COPD and Role of Pharmacotherapy: A Review

Abstract The topic of 24-hour management of COPD is related to day-to-night symptoms management, specific follow-up and patients’ adherence to therapy. COPD symptoms strongly vary during day and night, being worse in the night and early morning. This variability is not always adequately considered in the trials. Night-time symptoms are predictive of higher mortality and more frequent exacerbations; therefore, they should be a target of therapy. During night-time, in COPD patients the supine position is responsible for a different thoracic physiology; moreover, during some sleep phases the vagal stimulation determines increased bronchial secretions, increased blood flow in the bronchial circ…

Corrigendum to “Healthcare costs of the SATisfaction and adherence to COPD treatment (SAT) study follow-up” [Respir. Med. 153 (2019) 68–75]

COPD classification methods and informativeness on mortality: Contrasting evidences

Understanding whether the ABCD GOLD classification method is informative with respect to the spirometric classification of severity in predicting mortality of patients with chronic obstructive pulmonary disease (COPD) is subject of debate. The results of a study performed on a sample of the Norwegian population (HUNT2) were recently published. Such data showed the inferiority of ABCD classification in predicting mortality compared to the spirometric classification, which was considered the gold standard up to the 2011 version of GOLD guidelines. This result is not in line with the results of other studies that have shown the equivalence of the two classifications. The new GOLD classificatio…

Why use long acting bronchodilators in chronic obstructive lung diseases? An extensive review on formoterol and salmeterol

Abstract Long-acting β 2 -adrenoceptor agonists, formoterol and salmeterol, represent a milestone in the treatments of chronic obstructive lung diseases. Although no specific indications concerning the choice of one molecule rather than another are provided by asthma and COPD guidelines, they present different pharmacological properties resulting in distinct clinical employment possibilities. In particular, salmeterol has a low intrinsic efficacy working as a partial receptor agonist, while formoterol is a full agonist with high intrinsic efficacy. From a clinical perspective, in the presence of low β 2 -adrenoceptors availability, like in inflamed airways, a full agonist can maintain its b…

Oral CorticoSteroid sparing with biologics in severe asthma: A remark of the Severe Asthma Network in Italy (SANI)

According to the data derived from several national and international registries, including SANI (Severe Asthma Network Italy), and considering the strong impact that frequent or regular use of oral corticosteroid has on quality of life (QoL) of severe asthmatics, as well as on the costs for managing corticosteroid-related diseases, oral corticosteroid sparing up to withdrawal should be considered a primary outcome in the management of severe asthma. New biologics have clearly demonstrated that this effect is possible, with concomitant reduction in the rate of exacerbations and in symptom control. Then, there is no reason for using so frequently oral corticosteroid before having explored al…

Healthcare costs of the SATisfaction and adherence to COPD treatment (SAT)study follow-up

Abstract Background Chronic obstructive pulmonary disease (COPD) is characterised by recurring exacerbations. We estimated the costs of healthcare resources for COPD management funded by the Italian National Healthcare Service (INHS) for one year. Methods We examined the demographic, clinical, and economic variables at enrolment and follow-up visits (at 6 and 12 months) of COPD patients participating in the SAT study and referred to 20 Italian pulmonary centres with different institutional characteristics. Costs were expressed in Euro (€) 2018. A random effects log-linear panel regression model was performed to predict the average cost per patient. Results Most of the centres were public in…

What drives inhaler prescription for asthma patients? Results from a real-life retrospective analysis

Abstract Background The choice of inhaler device for asthma patients depends upon multiple attributes. We investigated factors that may drive general practitioners (GPs) and respiratory specialists in the prescription of inhaler devices for asthma patients who initiated inhalation therapy. Methods We retrospectively analysed prescriptions by GPs and respiratory specialists to asthma patients commencing inhaled corticosteroid/long-acting β2-agonist combination therapy available as both pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs). Patient characteristics were compared by device and multivariate analysis was used to model the likelihood of receiving a pMDI as oppos…

Differences in the efficacy and safety among inhaled corticosteroids (ICS)/long-acting beta2-agonists (LABA) combinations in the treatment of chronic obstructive pulmonary disease (COPD): Role of ICS

Inhaled corticosteroids (ICS) are frequently recommended for the treatment of asthma and COPD, often in combination with long-acting beta2-agonists (LABA), depending on the severity of the disease and/or on the specific phenotype. Several ICS/LABA combinations are currently available that differ in their pharmacokinetic characteristics and dose of both components. Thus, this review assesses differences in the efficacy and the safety profiles of the ICS components in the two more frequently used ICS/LABA combinations (budesonide/formoterol and fluticasone/salmeterol) for the management of COPD. Whereas the basic mechanism of action is similar for all ICS (binding with the intracellular gluco…

Exploring the Relationship between Disease Awareness and Outcomes in Patients with Chronic Obstructive Pulmonary Disease

<b><i>Background:</i></b> Disease awareness is a challenge in the management of chronic obstructive pulmonary disease (COPD). <b><i>Objectives:</i></b> The aim of this analysis was to explore the association between COPD optimal and suboptimal awareness, clinical parameters, and the following patient-reported outcomes: modified Medical Research Council (mMRC), Treatment Satisfaction Questionnaire (TSQM-9), COPD Assessment Test (CAT), Morisky Medication-Taking Adherence Scale (MMAS-4), and Brief Illness Perception Questionnaire (B-IPQ). <b><i>Methods:</i></b> This post hoc analysis of the SAT study included all enrolled …

Effects of aclidinium on determinants of COPD severity: symptoms and quality of life

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 G…

Symptom variability and control in COPD: Advantages of dual bronchodilation therapy

Abstract 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 wi…

Cost-description and multiple imputation of missing values: theSATisfaction and adherence to COPD treatment(SAT) study

Aim:This article reports on a retrospective quarterly cost description (CD) performed on 401 patients with stable chronic obstructive pulmonary disease (COPD) at enrolment in the national, multicen...

Suggestions for lung function testing in the context of COVID-19

The 2019 coronavirus disease (COVID-19) pandemic is currently a challenge worldwide. Due to the characteristics of lung function tests, the risk of cross infection may be high between health care workers and patients. The role of lung function testing is well defined for the diagnosis of various diseases and conditions. Lung function tests are also indispensable in evaluating the response to medical treatment, in monitoring patient respiratory and systemic pathologies, and in evaluating preoperative risk in cardiothoracic and major abdominal surgeries. However, lung function testing represents a potential route for COVID-19 transmission, due to the aerosol generated during the procedures an…

Reviewer_2_v.1 – Supplemental material for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study

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

The hidden burden of severe asthma: from patient perspective to new opportunities for clinicians

Severe asthma is an important topic in respiratory diseases, due to its high impact on morbidity and mortality as well as on health-care resources. The many challenges that still exist in the management of the most difficult-to-treat forms of the disease, and the acknowledgement of the existence of unexplored areas in the pathophysiological mechanisms and the therapeutic targets represent an opportunity to gather experts in the field with the immediate goals to summarize current understanding about the natural history of severe asthma and to identify gaps in knowledge and research opportunities, with the aim to contribute to improved medical care and health outcomes. This article is a conse…

Late Breaking Abstract - Relationship between clinical features and mortality in a cohort of COPD patients

Background: Chronic obstructive pulmonary disease (COPD) is a progressive disease with poor outcomes, including a high mortality. GULP is a multicenter Italian study that described clinical characteristics, exacerbation rates and survival of a cohort of COPD patients, as part of AstraZeneca’s AvoidEX program. Aims and objectives: To evaluate whether the clinical profile of subjects enrolled in the GULP study predicts mortality on a period of 3 years. Methods: Post-hoc analysis of an observational, multicenter, retrospective study. Patients were stratified according to survival status: alive (A) and dead (D). Clinical characteristics, comorbidities and exacerbation rates were reported in the…

Chronic obstructive lung disease “expert system”: validation of a predictive tool for assisting diagnosis

Fulvio Braido,1 Pierachille Santus,2 Angelo Guido Corsico,3 Fabiano Di Marco,4 Giovanni Melioli,5 Nicola Scichilone,6 Paolo Solidoro7 1Department of Internal Medicine, IRCCS San Martino di Genova University Hospital, Genoa, Italy; 2Department of Biomedical and Clinical Sciences, University of Milan, Division of Respiratory Diseases, “L. Sacco” University Hospital, ASST Fatebenefratelli-Sacco, Milan, Italy; 3Department of Internal Medicine and Therapeutics, Division of Respiratory Diseases, IRCCS Policlinico San Matteo Foundation, University of Pavia, Italy; 4Department of Health Sciences, University of Milan, San Paolo Hospital, Milan, Italy; 5Center for Precision Medici…

Disability in moderate chronic obstructive pulmonary disease: Prevalence, burden and assessment-results from a real-life study

<b><i>Background:</i></b> The role of disability and its association with patient-reported outcomes in the nonsevere forms of chronic obstructive pulmonary disease (COPD) has never been explored. <b><i>Objectives:</i></b> The aim of this study was to assess, in a cross-sectional real-life study, the prevalence and degree of disability in moderate COPD patients and to assess its association with health status, illness perception, risk of death and well-being. <b><i>Methods:</i></b> Moderate COPD outpatients attending scheduled visits were involved in a quantitative research program using a questionnaire-based data collec…

Asthma management in a specialist setting: Results of an Italian Respiratory Society survey.

Abstract 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…

Withdrawal of inhaled corticosteroids in COPD: A meta-analysis

Background Conflicting findings exist on the benefit of withdrawal of inhaled corticosteroid (ICS) in chronic obstructive pulmonary disease (COPD). We performed a quantitative synthesis in order to assess real impact of ICS discontinuation in COPD patients. Methods We carried out a meta-analysis via random-effects model on the available clinical evidence to evaluate the effect of ICS discontinuation in COPD. Randomized clinical trials and observational real-life studies investigating the effects of ICS withdrawal on the risk of COPD exacerbation, lung function (forced expiratory volume in 1 s [FEV1]) and quality of life (St. George's Respiratory Questionnaire [SGRQ]) were identified by sear…

Oxidative Stress and Respiratory System: Pharmacological and Clinical Reappraisal of N-Acetylcysteine

Abstract The large surface area for gas exchange makes the respiratory system particularly susceptible to oxidative stress-mediated injury. Both endogenous and exogenous pro-oxidants (e.g. cigarette smoke) trigger activation of leukocytes and host defenses. These mechanisms interact in a ìmultilevel cycleî responsible for the control of the oxidant/antioxidant homeostasis. Several studies have demonstrated the presence of increased oxidative stress and decreased antioxidants (e.g. reduced glutathione [GSH]) in subjects with chronic obstructive pulmonary disease (COPD), but the contribution of oxidative stress to the pathophysiology of COPD is generally only minimally discussed. The aim of t…

Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial

Background: ANDHI was done to assess the efficacy of benralizumab, including onset of effect and impact on health-related quality of life (HRQOL), exacerbation rate, lung function, and nasal polyposis symptoms. Methods: This phase 3b, randomised, double-blind, parallel-group, placebo-controlled ANDHI study was completed in adults (aged 18–75 years) with severe eosinophilic asthma with at least 2 exacerbations in the previous year, despite high-dose inhaled corticosteroid plus additional controllers, screening blood eosinophil counts of at least 150 cells per μL, and an Asthma Control Questionnaire 6 (ACQ-6) score of 1·5 or more. Patients who met eligibility criteria were randomly assigned (…

Which factors affect the choice of the inhaler in chronic obstructive respiratory diseases?

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 …

Disease awareness in patients with COPD: measurement and extent

Ilaria Baiardini,1 Paola Rogliani,2 Pierachille Santus,3 Angelo G Corsico,4 Marco Contoli,5 Nicola Scichilone,6 Fabiano Di Marco,7 Patrizia Lessi,8 Carla Scognamillo,8 Giorgia Molinengo,9 Fabio Ferri,10 Vincenzo Patella,11 Giuseppe Fiorentino,12 Mauro Carone,13 Fulvio Braido14 1Department of Biomedical Sciences, Humanitas University, Milan, Italy; 2Respiratory Unit, Department of Experimental Medicine, University of Rome “Tor Vergata”, Rome, Italy; 3Department of Biomedical and Clinical Sciences (DIBIC), University of Milan, Milan, Italy; 4Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy; 5Department of Medical Sciences, University of F…

Factors reducing omalizumab response in severe asthma

Background: Despite adding Omalizumab to conventional therapy, several severe asthmatics still show poor disease control. We investigated the factors that may affect a reduced Omalizumab response in a large population of severe asthmatics. Methods: 340 patients were retrospectively evaluated. FEV1%, FVC%, Asthma Control Test (ACT), fractional exhaled nitric oxide (FENO), possible step-downs/step-ups of concomitant therapies, exacerbations, disease control levels, ICS doses and SABA use, observed at the end of treatment, were considered as a response to Omalizumab. Results: Age was an independent risk factor for a reduced response concerning FEV1%, FVC%, ACT and for a lower asthma control. O…

Corrigendum to “Which factors affect the choice of the inhaler in chronic obstructive respiratory diseases?” [YPUPT 31C (2015) 63–67]

NA

Severe asthma: One disease and multiple definitions

Abstract Introduction There is, so far, no universal definition of severe asthma. This definition usually relies on: number of exacerbations, inhaled therapy, need for oral corticosteroids, and respiratory function. The use of such parameters varies in the different definitions used. Thus, according to the parameters chosen, each patient may result in having severe asthma or not. The aim of this study was to evaluate how the choice of a specific definition of severe asthma can change the allocation of patients. Methods Data collected from the Severe Asthma Network Italy (SANI) registry were analyzed. All the patients included were then reclassified according to the definitions of U-BIOPRED,…

<p>Early management of COPD: where are we now and where do we go from here? A Delphi consensus project</p>

Purpose There is a lack of consensus on the most appropriate early diagnostic strategy, criteria for early access to treatment and follow-up approach for patients with COPD. Materials and methods A Delphi consensus project investigated the early management of COPD. We formulated two questionnaires for completion by pneumologists in Italy. Results A total of 207 specialists completed questionnaire 1 and 184 of them questionnaire 2, between November 2016 and October 2017. Early diagnosis of COPD was considered uncommon for 93.2% of the expert panel. Regardless of the definition of "early diagnosis" - a diagnosis made before the clinical manifestation of the disease for most responders (60.4%)…

Use of ICS in COPD: From Blockbuster Medicine to Precision Medicine

Chronic obstructive pulmonary disease (COPD) is a major cause of mortality worldwide, whose burden is expected to increase in the next decades, because of numerous risk factors, including the aging of the population. COPD is both preventable and treatable by an effective management including risk factor reduction, prevention, assessment, and treatment of acute exacerbations and co-morbidities. The available agents approved for COPD treatment are long-acting or ultra-long-acting β2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) bronchodilators, as well as inhaled corticosteroids (ICS) in combination with LABAs. ICS use has been restricted only to selected COPD patients by th…

The role of cefditoren in the treatment of lower community-acquired respiratory tract infections (LRTIs): from bacterial eradication to reduced lung inflammation and epithelial damage

Lower respiratory tract infections (LRTIs), including pneumonia and acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD), are among the most common diagnoses in both outpatient and inpatient settings. Due to the burden of LRTIs healthcare providers must adopt practices focused on improving outcomes with the aim to reduce treatment failure and antibiotic resistances. Moreover, the role of acute and chronic infection in the pathogenesis of COPD has received considerable attention, since chronic infection can contribute to airways inflammation and COPD progression. This review discusses the role of cefditoren for the treatment of LRTIs, compared with the definition of "appropria…

Contoli_et_al_Additional_file20190924 – Supplemental material for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study

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

Clinical and Functional Characteristics of COPD Patients Across GOLD Classifications: Results of a Multicenter Observational Study.

Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease. The severity grading systems proposed by the Global initiative for Chronic Obstructive Lung Disease (GOLD) have changed over time. The aim of the study was to evaluate if the different GOLD classifications can capture the complexity of the disease by investigating the distribution of lung function and clinical parameters across the GOLD classification systems. This was an observational, retrospective, multicentre study. COPD patients were stratified according to the GOLD severity grading proposed in the 2007, and to the ABCD assessment tool present in the 2011, and 2017 versions of the initiative. Data from body plethy…

<p>Day and Night Control of COPD and Role of Pharmacotherapy: A Review</p>

The topic of 24-hour management of COPD is related to day-to-night symptoms management, specific follow-up and patients' adherence to therapy. COPD symptoms strongly vary during day and night, being worse in the night and early morning. This variability is not always adequately considered in the trials. Night-time symptoms are predictive of higher mortality and more frequent exacerbations; therefore, they should be a target of therapy. During night-time, in COPD patients the supine position is responsible for a different thoracic physiology; moreover, during some sleep phases the vagal stimulation determines increased bronchial secretions, increased blood flow in the bronchial circulation (…

Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study

Background: Understanding the level of patients’ satisfaction with treatment and its determinants have the potential to impact therapeutic management and clinical outcome in chronic conditions such as chronic obstructive pulmonary disease (COPD). Methods: A national, multicenter, longitudinal, observational study of COPD from 20 Italian pulmonary centers to explore patients’ satisfaction to treatment [assessed by the Treatment Satisfaction Questionnaire, 9 items (TSQM-9)] and association with clinical parameters [including dyspnea score, COPD Assessment Test (CAT) score, exacerbation rate], adherence to treatment [Morisky Medication-Taking Adherence Scale (MMAS-4)], illness perception [eval…

Effects of aclidinium on determinants of COPD severity: symptoms and quality of life

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 …

Quality standards for the management of bronchiectasis in Italy: A national audit

Although historically considered a neglected disease, bronchiectasis has become a disease of renewed interest over recent decades in light of an increase in prevalence and a substantial burden on healthcare systems. In 2010, the British Thoracic Society (BTS) published guidelines on the management of bronchiectasis in adults, along with specific quality standards. To date, these represent the only quality standards available in Europe. These have been tested over a number of years in the UK with progressive improvements in the standard of care. No national guidelines are available in Italy and no indications on which guideline should be followed have been given by the Italian Society of Res…

Reviewer_1_v.1 – Supplemental material for Satisfaction with chronic obstructive pulmonary disease treatment: results from a multicenter, observational study

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

Genuair® Usability Test: Results of a National Public Survey of the Elderly

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 “pra…

Late Breaking Abstract - Validation of a tool for the assessment of disease awareness (DA) in COPD

Background: DA could influence adherence to treatment and outcomes. No validated tools are available to assess DA in COPD Aims: To generate a tool able to explore DA in COPD patients, the Disease Awareness in COPD Questionnaire (DACQ) Methods: A 2-step Delphi approach was used to develop a questionnaire that was tested for validity in a cohort of COPD patients of an Italian observational, multicenter, prospective study (SAT study - NCT02689492) Results: Consensus on a 27-item provisional questionnaire was obtained with 2 Delphi rounds. Factor analysis showed a 4-factor solution accounting for 35% of variance; each factor (disease acceptance, awareness of treatment needs, disease knowledge, …

Assessing and accessing the small airways; implications for asthma management

Despite the wealth of experience in the management of asthma, the disease remains inadequately controlled in some patients, who face long-term respiratory impairment and disability. The disease has been characterised as an inflammatory condition affecting first the larger airways and eventually the smaller airways, but there is evidence that peripheral airway involvement defines a particular and more severe phenotype of asthma. For this reason, assessing functional and biological parameters reflective of small airways involvement is important prognostically. No assessment method is universally and directly representative of peripheral airway function, but the traditional spirometric tests, …

Beliefs and preferences regarding biological treatments for severe asthma

Background: Severe asthma is a serious condition with a significant burden on patients' morbidity, mortality, and quality of life. Some biological therapies targeting the IgE and interleukin-5 (IL5) mediated pathways are now available. Due to the lack of direct comparison studies, the choice of which medication to use varies. We aimed to explore the beliefs and practices in the use of biological therapies in severe asthma, hypothesizing that differences will occur depending on the prescribers’ specialty and experience. Methods: We conducted an online survey composed of 35 questions in English. The survey was circulated via the INterasma Scientific Network (INESNET) platform as well as throu…

Economic impact of mepolizumab in uncontrolled severe eosinophilic asthma, in real life

Abstract Background and aims Severe asthma is burdened by frequent exacerbations and use of oral corticosteroids (OCS) which worsen patients’ health and increase healthcare spending. Aim of this study was to assess the clinical and economic effect of adding mepolizumab (MEP) for the treatment of these patients. Methods Patients >18 years old, referred to 8 asthma clinics, starting MEP between May 2017 and December 2018, were enrolled and followed-up for 12 months. Information in the 12 months before mepolizumab were collected retrospectively. The evaluation parameters included: OCS use, number of exacerbations/hospitalizations, concomitant therapies, comorbidity, and annual number of workin…

Chronic obstructive lung disease “expert system”: Validation of a predictive tool for assisting diagnosis

Purpose: The purposes of this study were development and validation of an expert system (ES) aimed at supporting the diagnosis of chronic obstructive lung disease (COLD). Methods: A questionnaire and a WebFlex code were developed and validated in silico. An expert panel pilot validation on 60 cases and a clinical validation on 241 cases were performed. Results: The developed questionnaire and code validated in silico resulted in a suitable tool to support the medical diagnosis. The clinical validation of the ES was performed in an academic setting that included six different reference centers for respiratory diseases. The results of the ES expressed as a score associated with the risk of su…

Supplementary_Material – Supplemental material for Cost-description and multiple imputation of missing values: the SATisfaction and adherence to COPD treatment (SAT) study

Supplemental material, Supplementary_Material for Cost-description and multiple imputation of missing values: the SATisfaction and adherence to COPD treatment (SAT) study by Carlo Lazzaro, Fabiano Di Marco, Nicola Scichilone, Fulvio Braido, Marco Contoli, Paola Rogliani, Pierachille Santus, Valentina Acciai, Carla Scognamillo, Irene Olivi and Angelo Guido Corsico in Global & Regional Health Technology Assessment