Regular versus as-needed budesonide and formoterol combination treatment for moderate asthma: A non-inferiority, randomised, double-blind clinical trial

Summary Background Treatment guidelines for patients with moderate persistent asthma recommend regular therapy with a combination of an inhaled corticosteroid and a longacting β 2 agonist plus as-needed rapid-acting bronchodilators. We investigated whether symptom-driven budesonide and formoterol combination therapy administered as needed would be as effective as regular treatment with this combination plus as-needed symptom-driven terbutaline for patients with moderate asthma. Methods In this non-inferiority randomised clinical trial, we recruited adult patients (18–65 years of age) with stable moderate persistent asthma, according to 2006 Global Initiative for Asthma guidelines. Patients …

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

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

Association of increased CCL5 and CXCL7 chemokine expression with neutrophil activation in severe stable COPD

BACKGROUND: Increased numbers of activated neutrophils have been reported in the bronchial mucosa of patients with stable chronic obstructive pulmonary disease (COPD), particularly in severe disease. OBJECTIVES: To investigate the expression of neutrophilic chemokines and adhesion molecules in bronchial biopsies from patients with stable COPD of different severity (GOLD stages I-IV) compared with age-matched control subjects, smokers with normal lung function and never smokers. METHODS: The expression of CCL5, CXCL1, 5, 6, 7 and 8, CXCR1, CXCR2, CD11b and CD44 was measured in the bronchial mucosa using immunohistochemistry, confocal immunofluorescence, real-time quantitative polymerase chai…

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…

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…

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...

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

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…

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…

Reply to: Kow CS et al. Are severe asthma patients at higher risk of developing severe outcomes from COVID-19?

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…

The Contribution of Small-Airway Abnormalities in Chronic Obstructive Pulmonary Disease Clinical Manifestations: More than a Functional Issue.

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…

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…

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…

COVID-19 in Severe Asthma Network in Italy (SANI) patients: Clinical features, impact of comorbidities and treatments

To the Editor Since the end of February 2020 Italy, first non- Asian Country, has reported an ever increasing number of COronaVIrus Disease 19 (COVID-19) patients, which has reached over 200,000 confirmed Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) infected subjects and resulted in more than 34000 deaths (data updated to June 19th, 20201).Patients with asthma are potentially more severely affected by by SARS-CoV-2 infection 2 and it is well established that respiratory viral infections are associated with severe adverse outcomes in patients with asthma, including increased risk of asthma exacerbation episodes 3. Nonetheless, according to the epidemiological studies publishe…

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 …

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

TGF-β Signaling Pathways in Different Compartments of the Lower Airways of Patients With Stable COPD

Background: The expression and localization of transforming growth factor-β (TGF-β) pathway proteins in different compartments of the lower airways of patients with stable COPD is unclear. We aimed to determine TGF-β pathway protein expression in patients with stable COPD. Methods: The expression and localization of TGF-β pathway components was measured in the bronchial mucosa and peripheral lungs of patients with stable COPD (n = 44), control smokers with normal lung function (n = 24), and control nonsmoking subjects (n = 11) using immunohistochemical analysis. Results: TGF-β1, TGF-β3, and connective tissue growth factor expression were significantly decreased in the bronchiolar epithelium…

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, …

T helper type 17-related cytokine expression is increased in the bronchial mucosa of stable chronic obstructive pulmonary disease patients.

Summary There are increased numbers of activated T lymphocytes in the bronchial mucosa of stable chronic obstructive pulmonary disease (COPD) patients. T helper type 17 (Th17) cells release interleukin (IL)-17 as their effector cytokine under the control of IL-22 and IL-23. Furthermore, Th17 numbers are increased in some chronic inflammatory conditions. To investigate the expression of interleukin (IL)-17A, IL-17F, IL-21, IL-22 and IL-23 and of retinoic orphan receptor RORC2, a marker of Th17 cells, in bronchial biopsies from patients with stable COPD of different severity compared with age-matched control subjects. The expression of IL-17A, IL-17F, IL-21, IL-22, IL-23 and RORC2 was measure…

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…

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