Long-term residential exposure to air pollution and risk of chronic respiratory diseases in Italy: The BIGEPI study

: Long-term exposure to air pollution has adverse respiratory health effects. We investigated the cross-sectional relationship between residential exposure to air pollutants and the risk of suffering from chronic respiratory diseases in some Italian cities. In the BIGEPI project, we harmonised questionnaire data from two population-based studies conducted in 2007-2014. By combining self-reported diagnoses, symptoms and medication use, we identified cases of rhinitis (n = 965), asthma (n = 328), chronic bronchitis/chronic obstructive pulmonary disease (CB/COPD, n = 469), and controls (n = 2380) belonging to 13 cohorts from 8 Italian cities (Pavia, Turin, Verona, Terni, Pisa, Ancona, Palermo,…

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…

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

OSACO: an observational study in asthma-COPD overlap syndrome (ACOS)

Background: ACOS describes the co-occurrence of asthma and COPD, although its prevalence and clinical features remain poorly characterized. Aims: To better understand the prevalence and characteristics of ACOS. Methods: An observational study is being performed in subjects with bronchial obstruction at 3 Italian centers. In the first phase, consecutive patients ≥40 years with documented bronchial obstruction are being recruited; eligible patients will enter the second phase, consisting of imaging, functional and clinical evaluation with the MRC dyspnea scale, St. George9s respiratory questionnaire index, Charlson index, and skin prick test. Main inclusion criteria for the evaluation phase a…

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…

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 …

<p>Bacterial load and inflammatory response in sputum of alpha-1 antitrypsin deficiency patients with COPD</p>

Background Airway inflammation may drive the progression of chronic obstructive pulmonary disease (COPD) associated with alpha-1 antitrypsin deficiency (AATD), but the relationship between airway microbiota and inflammation has not been investigated. Methods We studied 21 non-treated AATD (AATD-noT) patients, 20 AATD-COPD patients under augmentation therapy (AATD-AT), 20 cigarette smoke-associated COPD patients, 20 control healthy smokers (CS) and 21 non-smokers (CON) with normal lung function. We quantified sputum inflammatory cells and inflammatory markers (IL-27, CCL3, CCL5, CXCL8, LTB4, MPO) by ELISA, total bacterial load (16S) and pathogenic bacteria by qRT-PCR. Results AATD-AT patient…

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…

Minimal clinically important difference for asthma endpoints: an expert consensus report

Minimal clinically important difference (MCID) can be defined as the smallest change or difference in an outcome measure that is perceived as beneficial and would lead to a change in the patient's medical management.The aim of the current expert consensus report is to provide a “state-of-the-art” review of the currently available literature evidence about MCID for end-points to monitor asthma control, in order to facilitate optimal disease management and identify unmet needs in the field to guide future research.A series of MCID cut-offs are currently available in literature and validated among populations of asthmatic patients, with most of the evidence focusing on outcomes as patient repo…

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…

Protocol for the EARCO Registry

Rationale and objectives Alpha-1 antitrypsin deficiency (AATD) is a genetic condition that leads to an increased risk of emphysema and liver disease. Despite extensive investigation, there remain unanswered questions concerning the natural history, pathophysiology, genetics and the prognosis of the lung disease in association with AATD. The European Alpha-1 Clinical Research Collaboration (EARCO) is designed to bring together researchers from European countries and to create a standardised database for the follow-up of patients with AATD. Study design and population The EARCO Registry is a non-interventional, multicentre, pan-European, longitudinal observational cohort study enrolling patie…

Validation of Murray sputum purulence scale in the Italian Registry of Bronchiectasis (IRIDE)

Introduction: Murray sputum colour chart stratifies patients according to the presence of mucous (M), muco-purulent (MP) or purulent (P) sputum, and has not been validated in Bx yet. We aimed to validate this scale across a large Italian cohort of Bx patients. Methods: A secondary analysis of the IRIDE database was conducted including adults with Bx and daily sputum production enrolled across 13 Italian centres between 2014 and 2017. M vs. MP vs. P sputum producers were identified and clinical, functional and microbiological data were collected. Clinical outcomes during a two-year follow up period were evaluated in the Monza and Milan cohorts. A sensitivity analysis excluding COPD patients …

Depression is associated with poor control of symptoms in asthma and rhinitis: A population-based study

Abstract Background Although many studies have highlighted the link between asthma/rhinitis and depression, it is still unclear which characteristics of these diseases are associated with the risk of depression. We aimed to explore the relationship between depression and asthma or rhinitis in a representative sample of the Italian general population. Methods The data were collected in GEIRD, an Italian multicenter, population-based, multicase-control study. 2227 participants (age 21–86 years, female 50%) underwent standardized interviews, skin prick and lung function tests, and were divided into cases of current asthma (n = 528), rhinitis without asthma (n = 972), and controls (n = 727). Tw…

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…

Effects of a structured educational intervention in moderate-to-severe elderly asthmatic subjects.

Background: Adherence to inhaled drugs is linked to patients’ satisfaction with their device, and an incorrect use can negatively affect the outcomes of asthma treatment. We speculated that this is particularly true in elderly asthmatic subjects. Aim: We performed a national pre-post interventional multicentre study, enrolling moderate-to-severe asthmatic subjects aged ≥65 ​years treated with fixed inhaled combination drugs by dry powder inhaler (DPI) or pressurized metered dose inhaler (pMDI). Adherence and critical errors were evaluated by means of validated questionnaires at first visit (V1) and after 3–6 months (V2). At V1, subjects underwent intensive training on the correct use of the…

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…

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…

Gastritis and gastroesophageal reflux disease are strongly associated with non-allergic nasal disorders

AbstractBackgroundGastroesophageal reflux disease (GERD) has been reported to be significantly associated with chronic rhinosinusitis, but the strength of the association is still debated.AimsTo evaluate the strength of the association between gastritis/GERD and non-allergic rhinitis (NAR)/allergic rhinitis (AR)/sinusitis.MethodsWe investigated 2887 subjects aged 20–84 years, who underwent a clinical visit in seven Italian centres (Ancona, Palermo, Pavia, Terni, Sassari, Torino, Verona) within the study on Gene Environment Interactions in Respiratory Diseases, a population-based multicase-control study between 2008 and 2014. Subjects were asked if they had doctor-diagnosed “gastritis or sto…

Relationship status and respiratory diseases: an analysis on a general population sample

Background: Very few studies have examined whether marital/relationship status affects respiratory diseases. Objective: Assess the association of relationship status (Rstatus: domestic partnership/civil union/marriage, cohabitation with non-partners, being single) with current (CA) and past asthma (PA), allergic (AR) and non-allergic rhinitis (NAR), and chronic bronchitis (CB). Methods: Data were collected in the frame of GEIRD, a population-based, multicase-control survey. Among 2531 subjects (age 21–86, female 50%) who underwent standardized interviews, skin prick and lung function tests, 575 cases of CA, 268 cases of PA, 968 cases of AR, 462 cases of NAR, 265 cases of CB without airflow …

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,…

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…

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…

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…

The EDUCA (Elderly and Device Use in Chronic Asthma) multicentre Italian study on the assessment of errors and satisfaction in using the inhalers in elderly asthmatics: Preliminary results

Background: The incorrect use of inhalers can negatively affect the outcomes of asthma treatment. We assessed whether, and to what extent, this is the case in elderly asthmatics. Methods: This is an observational, multicentre Italian study enrolling mild-to-severe asthmatic patients aged ≥65 yrs treated with inhaled drugs, by DPI or pressurized MDI (pMDI). Critical errors, patient9s satisfaction with their inhaler and adherence were evaluated by means of validated questionnaires; the patients were also trained to a correct use of their device. After 3 to 6 months patient were revaluated. Results: To date, 312 patients have been included (41% males, median age 71 yrs). At least one critical …

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, …