Publications by authors named "Fulvio Braido"

126 Publications

Differentiation of COVID-19 signs and symptoms from allergic rhinitis and common cold- An ARIA-EAACI-GA LENconsensus.

Authors:
Jan Hagemann Gabrielle L Onorato Marek Jutel Cezmi A Akdis Ioana Agache Torsten Zuberbier Wienczyslawa Czarlewski Joaquim Mullol Anna Bedbrook Claus Bachert Kazi S Bennoor Karl-Christian Bergmann Fulvio Braido Paulo Camargos Luis Caraballo Victoria Cardona Thomas Casale Lorenzo Cecchi Tomas Chivato Derek K Chu Cemal Cingi Jaime Correia-de-Sousa Stefano Del Giacco Dejan Dokic Mark Dykewicz Motohiro Ebisawa Yehia El-Gamal Regina Emuzyte Jean-Luc Fauquert Alessandro Fiocchi Wytske J Fokkens Joao A Fonseca Bilun Gemicioglu Maximiliano Gomez Gotua Maia Tari Haahtela Eckard Hamelmann Tomohisa Iinuma Juan Carlos Ivancevich Ewa Jassem Omer Kalayci Przemyslaw Kardas Musa Khaitov Piotr Kuna Violeta Kvedariene Desiree E Larenas-Linnemann Brian Lipworth Michael Makris Jorge F Maspero Neven Miculinic Florin Mihaltan Yousser Mohammad Stephen Montefort Mario Morais-Almeida Ralph Mösges Robert Naclerio Hugo Neffen Marek Niedoszytko Robyn E O'Hehir Ken Ohta Yoshitaka Okamoto Kimi Okubo Petr Panzner Nikolaos G Papadopoulos Giovanni Passalacqua Vincenzo Patella Ana Pereira Oliver Pfaar Davor Plavec Todor A Popov Emmanuel P Prokopakis Francesca Puggioni Filip Raciborski Jere Reijula Frederico S Regateiro Sietze Reitsma Antonino Romano Nelson Rosario Menachem Rottem Dermot Ryan Boleslaw Samolinski Joaquin Sastre Dirceu Solé Milan Sova Cristiana Stellato Charlotte Suppli-Ulrik Ioanna Tsiligianni Antonio Valero Arunas Valiulis Erkka Valovirta Tuula Vasankari Maria Teresa Ventura Dana Wallace De Yun Wang Iân Williams Arzu Yorgancioglu Osman M Yusuf Mario Zernotti Jean Bousquet Ludger Klimek

Allergy 2021 Mar 17. Epub 2021 Mar 17.

Department of Otolaryngology, Head and Neck Surgery, Universitätsmedizin Mainz, Mainz, Germany.

Background: Although there are many asymptomatic patients, one of the problems of COVID-19 is early recognition of the disease. COVID-19 symptoms are polymorphic and may include upper respiratory symptoms. However, COVID-19 symptoms may be mistaken withthe common cold or allergic rhinitis. An ARIA-EAACI study group attempted to differentiate upper respiratory symptoms betweenthe three diseases.

Methods: A modified Delphi process was used and ARIA members who were seeing COVID-19 patients were asked to fill in a questionnaire on the upper airway symptoms of COVID-19, common cold andallergic rhinitis.

Results: Among the 192 ARIA members who were invited to respond to the questionnaire, 89 responded. 87 questionnaires were analysed. The consensus was then reported.A two-way ANOVA analysis revealed significant differences inthe symptom intensity between the three diseases (p<0.001).

Conclusions: This modified Delphi approach enabled thedifferentiationof upper respiratory symptoms betweenCOVID-19, common cold and allergic rhinitis. An electronic algorithm will be devised using the questionnaire.
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http://dx.doi.org/10.1111/all.14815DOI Listing
March 2021

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

Respiration 2021 11;100(4):291-297. Epub 2021 Mar 11.

Respiratory Unit for Continuity of Care, Department of Internal Medicine, University of Genova, Genoa, Italy.

Background: Disease awareness is a challenge in the management of chronic obstructive pulmonary disease (COPD).

Objectives: 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).

Methods: This post hoc analysis of the SAT study included all enrolled patients for whom awareness (Disease Awareness in COPD Questionnaire - DACQ) was assessed at baseline and 12 months. DACQ scores ≥80 were considered an indicator of an optimal awareness.

Results: 367 patients (25.8% women, median age 72 years) were included in the analysis. At enrollment, 74 patients (20.2%) had a DACQ score ≥80. Patients with suboptimal awareness, compared to those in which awareness was optimal, had higher median scores for CAT (p = 0.0001) and mMRC (p = 0.0031), a lower median TSQM-9 global score (p < 0.0001), and higher median B-IPQ score (p < 0.0001). The proportion of patients who had exacerbations during the previous year was higher in patients with suboptimal COPD awareness than in those with DACQ score ≥80 (42.8 vs. 21.4%, p = 0.0009). During the 12-month observation period, illness perception, adherence, and treatment satisfaction were found to be independent factors significantly associated with level of disease awareness.

Conclusion: The results of our post hoc analysis suggest that patients' awareness of their COPD disease is related to both clinical outcomes and how they perceive and manage their condition.
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http://dx.doi.org/10.1159/000513953DOI Listing
March 2021

Epidemiology of severe asthma and international register.

Minerva Med 2021 Mar 8. Epub 2021 Mar 8.

Clinic of Respiratory Disease and Allergology, Department of Internal Medicine and Medical Specialties, University of Genoa, Genoa, Italy.

Severe asthma (SA) in an asthma that requires therapy with high dose inhaled corticosteroids with a second controller, or oral corticosteroids, to ensure that it does not become ''uncontrolled'', or that it does not respond to appropriate therapy. Severe asthma has a great impact on quality of life. There is a great heterogeneity of this disease, not only from a clinical point of view, but also from a functional and pathophysiological one. It's really hard to identify specific characteristics that identify this subgroup. Specific registers of SA, both national and international, are really important to describe the epidemiological characteristics of the disease and to analyze the clinical characteristics of the various subgroups of patients. This is an excellent starting point to be able to investigate the characteristics of the disease in detail.
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http://dx.doi.org/10.23736/S0026-4806.21.07281-5DOI Listing
March 2021

Quick Olfactory Sniffin' Sticks Test (Q-Sticks) for the detection of smell disorders in COVID-19 patients.

World Allergy Organ J 2021 Jan 20;14(1):100497. Epub 2021 Jan 20.

Department of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Genoa, Italy.

Background: Coronavirus disease (COVID-19) infection represents a worldwide critical health burden from the sanitary perspective. This disease's symptoms range from a mild flu-like form to a severe life-threatening respiratory disease and respiratory failure. Several patients, however, remain paucisymptomatic. Among the symptoms that seem relevant are the changes in taste and smell, regardless of the disease's severity.

Methods: Data from patients affected by COVID-19 infection, hospitalized from 15 to 29 April, 2020, were analyzed. Questionnaires about smell, taste, and nasal function were administered to all, and a proportion also received the Quick olfactory Sniffin' Sticks Test (q-Sticks) to objectivate the presence of anosmia or hyposmia. The results of instruments and Q-Sticks were then compared.

Results: Thirty-seven patients (20 males, 54.1%), with a mean age 0f 69.19 years (SD = 17.96; median 76, IQR: 63-82) were evaluated. Among the patients, 8 (22%) were asymptomatic. Out of the remaining 29 patients, 28 (97%) had fever, 19 (66%) asthenia, 11 (38%) dry cough, 10 (34%) dyspnea, and 6 (21%) gastroenteric symptoms. The q-Sticks test was performed on 27 patients and showed that 6 with anosmia, and 16 patients had hyposmia, where only 5 (14%) patients complained of loss of smell by conducting the questionnaires.

Conclusion: Although olfactory disturbances may be secondary to other factors, a sudden onset of anosmia or hyposmia should be assessed as a possible symptom of COVID-19 infection. The use of questionnaires or anamnestic collection is sometimes not enough, while adding to them a simple test such as the q-Sticks test can provide more accurate and reliable data. A simple, easy-to-perform, and reliable tool (q-Sticks) for olfactory disorders assessment can be administered to identify the real size of anosmia in patients with COVID-19 infection and detect the early stage of infection or paucisymptomatic patients, therefore becoming important to reduce the spreading of the pandemic.
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http://dx.doi.org/10.1016/j.waojou.2020.100497DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7816565PMC
January 2021

Manifesto on united airways diseases (UAD): an Interasma (global asthma association - GAA) document.

J Asthma 2021 Mar 5:1-16. Epub 2021 Mar 5.

Department of Internal Medicine, University of Genoa, Genova, Italy.

Objective: The large amount of evidence and the renewed interest in upper and lower airways involvement in infectious and inflammatory diseases has led Interasma (Global Asthma Association) to take a position on United Airways Diseases (UAD).

Methods: Starting from an extensive literature review, Interasma executive committee discussed and approved this Manifesto developed by Interasma scientific network (INES) members.

Results: The manifesto describes the evidence gathered to date and defines, states, advocates, and proposes issues on UAD (rhinitis, rhinosinusitis and nasal polyposis), and concomitant/comorbid lower airways disorders (asthma, chronic obstructive pulmonary disease, bronchiectasis, cystic fibrosis, obstructive sleep apnoea) with the aim of challenging assumptions, fostering commitment, and bringing about change. UAD refers to clinical pictures characterized by the coexistence of upper and lower airways involvement, driven by a common pathophysiological mechanism, leading to a greater burden on patient's health status and requiring an integrated diagnostic and therapeutic plan. The high prevalence of UAD must be taken into account. Upper and lower airways diseases influence disease control and patient's quality of life.

Conclusions: Patients with UAD need to have a timely and adequate diagnosis, treatment, and, when recommended, referral for management in a specialized center. Diagnostic testing including skin prick or serum specific IgE, lung function, fractional exhaled nitric oxide (FeNO), polysomnography, allergen-specific immunotherapies, biological therapies and home based continuous positive airway pressure (CPAP) whenever these are recommended, should be part of the management plan for UAD. Education of medical students, physicians, health professionals, patients and caregivers on the UAD is needed.
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http://dx.doi.org/10.1080/02770903.2021.1879130DOI Listing
March 2021

Medical devices in allergy practice.

World Allergy Organ J 2020 Oct 30;13(10):100466. Epub 2020 Sep 30.

Hospital Quirónsalud Bizkaia, Erandio, Bilbao, Spain.

Medical devices provide people with some health benefits in terms of diagnosis, prevention, treatment, and monitoring of disease processes. Different medical specialties use varieties of medical devices more or less specific for them. Allergology is an interdisciplinary field of medical science and teaches that allergic reactions are of systemic nature but can express themselves at the level of different organs across the life cycle of an individual. Subsequently, medical devices used in allergology could be regarded as: 1) general, servicing the integral diagnostic and management principles and features of allergology, and 2) organ specific, which are shared by organ specific disciplines like pulmonology, otorhinolaryngology, dermatology, and others. The present position paper of the World Allergy Organization (WAO) is meant to be the first integral document providing structured information on medical devices in allergology used in daily routine but also needed for sophisticated diagnostic purposes and modern disease management. It is supposed to contribute to the transformation of the health care system into integrated care pathways for interrelated comorbidities.
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http://dx.doi.org/10.1016/j.waojou.2020.100466DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7529824PMC
October 2020

Beliefs and preferences regarding biological treatments for severe asthma.

World Allergy Organ J 2020 Jul 31;13(7):100441. Epub 2020 Jul 31.

Università di Genova, Dipartimento di Medicina Interna (DiMI), Italy.

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 through social media. Responses from allergists and pulmonologists, both those with experience of prescribing omalizumab with (OMA/IL5) and without (OMA) experience with anti-IL5 drugs, were compared.

Results: Two hundred eighty-five (285) valid questionnaires from 37 countries were analyzed. Seventy-on percent (71%) of respondents prescribed biologics instead of oral glucocorticoids and believed that their side effects are inferior to those of Prednisone 5 mg daily. Agreement with ATS/ERS guidelines for identifying severe asthma patients was less than 50%. Specifically, significant differences were found comparing responses between allergists and pulmonologists (Chi-square test, p < 0.05) and between OMA/IL5 and OMA groups (p < 0.05).

Conclusions: Uncertainties and inconsistencies regarding the use of biological medications have been shown. The accuracy of prescribers to correctly identify asthma severity, according to guidelines criteria, is quite poor. Although a substantial majority of prescribers believe that biological drugs are safer than low dose long-term treatment with oral steroids, and that they must be used instead of oral steroids, every effort should be made to further increase awareness. Efficacy as disease modifiers, biomarkers for selecting responsive patients, timing for outcomes evaluation, and checks need to be addressed by further research. Practices and beliefs regarding the use of asthma biologics differ between the prescriber's specialty and experience; however, the latter seems more significant in determining beliefs and behavior. Tailored educational measures are needed to ensure research results are better integrated in daily practice.
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http://dx.doi.org/10.1016/j.waojou.2020.100441DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7396819PMC
July 2020

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

Int J Chron Obstruct Pulmon Dis 2020 4;15:1269-1285. Epub 2020 Jun 4.

Department of Biomedicine and Internal and Specialistic Medicine (DIBIMIS), University of Palermo, Palermo, Italy.

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 (enhancing inflammation) and increased airway resistance (broncho-motor tone). Moreover, in COPD patients the circadian rhythm may be impaired. The role of pharmacotherapy in this regard is still poorly investigated. Symptoms can be grossly differentiated according to the different phenotypes of the disease: wheezing recalls asthma, while dyspnea is strongly related to emphysema (dynamic hyperinflation) or obstructive bronchiolitis (secretions). Those symptoms may be different targets of therapy. In this regard, GOLD recommendations for the first time introduced the concept of phenotype distinction suggesting the use of inhaled corticosteroids (ICS) particularly when an asthmatic pattern or eosiophilic inflammations are present, and hypothesized different approaches to target symptoms (ie, dyspnea) or exacerbations. Pharmacotherapy should be evaluated and possibly directed on the basis of circadian variations, for instance, supporting the use of twice-daily rapid-action bronchodilators and evening dose of ICS. Recommendations on day and night symptoms monitoring strategies and choice of the specific drug according to patient's profile are still not systematically investigated or established. This review is the summary of an advisory board on the topic "24-hour control of COPD and role of pharmacotherapy", held by five pulmonologists, experts in respiratory pathophysiology, pharmacology and sleep medicine.
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http://dx.doi.org/10.2147/COPD.S240033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7283230PMC
June 2020

How to apply the personalized medicine in obesity-associated asthma?

Expert Rev Respir Med 2020 09 7;14(9):905-915. Epub 2020 Jul 7.

Respiratory and Allergy Department, University of Genoa, Ospedale Policlinico San Martino , Genoa, Italy.

Introduction: Obesity-associated asthma (OA) is frequently severe, with an increased rate of hospitalizations, numerous comorbidities and low response to corticosteroids. Despite progress in applying for personalized medicine in asthma, no specific recommendations exist for the management of OA.

Areas Covered: The aim of this review is to summarize recent data about the relationship obesity-asthma, describe clinical characteristics, potential mechanisms involved and possible therapeutic interventions to improve OA outcomes. Extensive research in the PubMed was performed using the following terms: "asthma and obesity" and "obese asthma" in combination with "phenotypes", "airway inflammation", "biomarkers", "lung function", "weight loss", "lifestyle interventions", "therapies" Currently two phenotypes are described. Early-onset atopic asthma is conventional allergic asthma aggravated by the pro-inflammatory properties of adipose tissue in excess, while late-onset non-atopic asthma is due to airway dysfunction as a consequence of the chronic lung compression caused by the obese chest walls. Previous data showed that different therapeutic strategies used in weight loss have a positive impact on OA outcomes.

Expert Opinion: The presence of a multidisciplinary team (chest physician, nutritionist, exercise physiologist, physiotherapist, psychologist, bariatric surgeon) and the collaboration between different specialists are mandatory to optimize the management and to apply the personalized medicine in OA.
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http://dx.doi.org/10.1080/17476348.2020.1780123DOI Listing
September 2020

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

Eur Respir Rev 2020 Jun 3;29(156). Epub 2020 Jun 3.

Personalized Medicine, Asthma and Allergy - Humanitas Research Hospital, Rozzano, Italy.

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 reported outcomes, lung function and exercise tolerance. On the contrary, only scant and partial data are available for inflammatory biomarkers. These clearly represent the most interesting target for future development in diagnosis and clinical management of asthma, particularly in view of the several biologic drugs in the pipeline, for which regulatory agencies will soon require personalised proof of efficacy and treatment response predictors.
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http://dx.doi.org/10.1183/16000617.0137-2019DOI Listing
June 2020

Cross-cultural adaptation and validation of the RhinAsthma Patient Perspective (RAPP) in the Polish population.

Postepy Dermatol Alergol 2020 Feb 9;37(1):97-102. Epub 2020 Mar 9.

IRCCS Ospedale Policlinico San Martino, Università di Genova, Dipartimento di Medicina Interna (DiMI), Genova, Italy.

Introduction: The RhinAsthma Patient Perspective (RAPP) was developed in Italian to assess the Health Related Quality of Life (HRQoL) impairment in patients with asthma and allergic rhinitis (AR) in daily practice.

Aim: To cross-culturally validate the Polish version.

Material And Methods: The Polish version was administered to patients suffering from asthma and rhinitis in a prospective observational study. Polish RAPP, along with SF-12, ACT, and a Symptomatologic VAS was filled in twice, with a 4-week interval between visits. At visit 2, a Global Rating Scale (GRS) was completed to assess any change in health status. Internal consistency, validity, reliability, discriminant ability and responsiveness to change as well as Minimal Important Difference were determined.

Results: The factor and confirmatory analysis revealed a unidimensional structure of RAPP. Internal consistency was satisfactory with Cronbach's α (visit 1 = 0.85, visit 2 = 0.89). High reliability (ICC = 0.89 and a CCC = 0.94) was found. Validity analyses showed good correlations of the Polish RAPP with Physical and Mental Component Scores of SF-12. In addition, RAPP adequately discriminated patients on the basis of the asthma control level and rhinitis severity ( < 0.03 for all the analyses), and demonstrated to be sensitive to change. MID value was 1 point.

Conclusions: The study confirmed the reliability and validity of the Polish version of RAPP demonstrating that it is a useful tool in the assessment of HRQoL in patients with asthma and comorbid allergic rhinitis, in clinical practice.
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http://dx.doi.org/10.5114/ada.2020.93387DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7247060PMC
February 2020

The Relevance of Targeting Treatment to Small Airways in Asthma and COPD.

Respir Care 2020 Sep 24;65(9):1392-1412. Epub 2020 Mar 24.

Department of Internal Medicine, Respiratory Diseases and Allergy Clinic, University of Genova, Azienda Policlinico IRCCs San Martino, Genova, Italy.

COPD and asthma have different risk factors and pathogenesis, but they share a pathophysiologic hallmark characterized by small airways disease. Although difficult to explore and measure, modifications of distal airways' pathophysiology and biology represent an early sign of obstructive disease and should be researched and assessed in everyday clinical practice. In the last 15 years, computed microtomography scans have shed light on the anatomy and physiology of the so-called silent zone, and research devoted to investigate the effect of inhaled treatments on small airway pathophysiology has been increasing. This narrative review offers a historical summary of researchers and landmark studies that reported, defined, and advanced the research on small airways. We then discuss the latest findings on the role and characteristics of the small airways' inflammatory and cellular structure, and we describe the assessment tools available to detect small airways dysfunction in COPD and asthma and the effect of bronchodilators and inhaled steroids on functional and biological biomarkers. Finally, we analyze the newest technological therapeutic advances aimed at small airways treatment in terms of inhalation devices and small particle size molecules.
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http://dx.doi.org/10.4187/respcare.07237DOI Listing
September 2020

RAPP-children: A new tool for assessing quality of life in patients with asthma and rhinitis.

Clin Exp Allergy 2020 06 25;50(6):662-671. Epub 2020 Mar 25.

Institute for Biomedical Research and Innovation, National Research Council, Palermo, Italy.

Background: RhinAsthma Patient Perspective (RAPP) is a short, validated questionnaire for assessing health-related quality of life (HRQoL) in adult patients with comorbid asthma and rhinitis, while a paediatric version is still not available.

Objective: The current study aimed to develop and validate the RAPP-children questionnaire.

Methods: RAPP-children was derived by combining RhinAsthma-children subscales into five unique items. At baseline (T0) and after 30 days (T1), 150 children (6-11 years) with comorbid asthma (predominantly intermittent or mild persistent) and rhinitis were given the following: RAPP-children, RhinAsthma-children, Paediatric Asthma Quality of Life Questionnaire (PAQLQ, age >6 years), Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), Childhood Asthma Control Test (CACT), KiddyKindl (age 6 years) or KidKindl (age >6 years), and a Visual Analogue Scale for nasal symptoms (VAS). At the final visit, a Global Rating of Change (GRC) scale was administered. The approved study was registered on the central registration system ClinicalTrials.gov (ID: NCT03276416).

Results: RAPP-children fairly reproduced RhinAsthma-children scores (concordance correlation coefficients between 0.91 and 0.95). RAPP-children showed adequate convergent validity (absolute Spearman's rho larger than 0.5 with PAQLQ, PRQLQ, CACT, KiddyKindl/KidKindl, and VAS), internal consistency (Cronbach's alpha > 0.70), repeatability (intra-cluster correlation coefficient between 0.61 and 0.8) in the presence of clinical stability (GRC = 0), discriminant validity (sensitivity to asthma control status and rhinitis severity), and sensitivity to symptom improvements (GRC > 1). The minimal important difference (MID) was -20. Floor and ceiling effects were minimal. RAPP-children showed fair usability also in younger children (6-8 years).

Conclusion & Clinical Relevance: RAPP-children is a valid, five-item questionnaire for assessing HRQoL in children aged 6 to 11 years with concomitant asthma and rhinitis. Although further investigation is required in moderate and severe asthmatics, this tool can be useful in clinical trials and in routine medical practice for improving the management of respiratory allergy in children.
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http://dx.doi.org/10.1111/cea.13599DOI Listing
June 2020

Clinically significant differences in patient-reported outcomes evaluations in chronic spontaneous urticaria.

Curr Opin Allergy Clin Immunol 2020 06;20(3):261-267

Department of Internal Medicine, Respiratory Diseases and Allergy Clinic, University of Genova, Azienda Policlinico IRCCS San Martino, Genoa.

Purpose Of Review: The aim of this review is to highlight the conceptual and practical knowledge for interpreting score changes in patient-reported outcomes (PROs) that have been validated for chronic spontaneous urticaria (CSU).

Recent Findings: The urticaria guidelines recommends to assess PROs as Health-Related Quality of Life, disease activity and disease control, to detect the CSU impact and the overall treatment effect. To this aim it is crucial to determine the minimal important difference (MID) to assess if changes in questionnaire scores represent either perceived improvement or deterioration for patients. Methods for establishing the MID are well defined and are clustered into two broad categories: distribution-based and anchor-based.

Summary: For the majority of the available questionnaires for CSU, an MID has been defined, according to the results of various approaches. In most of the studies in our review, anchor-based methods, either alone or in combination with distribution ones, were used. The available information regarding MIDs across validated tools for CSU patients helps to interpret measurement scores and allows the implementation of PROs in routine practices.
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http://dx.doi.org/10.1097/ACI.0000000000000636DOI Listing
June 2020

What to consider before prescribing inhaled medications: a pragmatic approach for evaluating the current inhaler landscape.

Ther Adv Respir Dis 2019 Jan-Dec;13:1753466619884532

Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus C, Denmark.

Inhaled therapies are the cornerstone of treatment in asthma and chronic obstructive pulmonary disease, and there are a multitude of devices available. There is, however, a distinct lack of evidence-based guidance for healthcare providers on how to choose an appropriate inhaler. This review aims to summarise recent updates on topics related to inhaler choice, and to offer practical considerations for healthcare providers regarding currently marketed devices. The importance of choosing the right inhaler for the right patient is discussed, and the relative merits of dry powder inhalers, pressurised metered dose inhalers, breath-actuated pressurised metered dose inhalers, spacers and soft mist inhalers are considered. Compiling the latest studies in the devices therapy area, this review focuses on the most common types of handling errors, as well as the comparative rates of incorrect inhalation technique between devices. The impact of device-specific handling errors on inhaler performance is also discussed, and the characteristics that can impair optimal drug delivery, such as inhalation flow rate, inhalation volume and particle size, are compared between devices. The impact of patient perceptions, behaviours and problems with inhalation technique is analysed, and the need for appropriate patient education is also highlighted. The continued development of technology in inhaler design and the need to standardise study assessment, endpoints and patient populations are identified as future research needs. .
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http://dx.doi.org/10.1177/1753466619884532DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6900625PMC
June 2020

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

Ther Adv Respir Dis 2019 Jan-Dec;13:1753466619888128

Department of Biomedical and Clinical Sciences (DIBIC), Università di Milano, Division of Respiratory Diseases, 'L. Sacco' Hospital, Via G.B. Grassi 74, Milan 20157, Italy.

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 [evaluated by Brief Illness Perception Questionnaire (B-IPQ)] in a 1-year follow up.

Results: A total of 401 COPD patients were enrolled [69.4% group B Global Initiative for COPD (GOLD), considering 366 patients with available GOLD 2017 classification at enrollment]. At enrollment, satisfaction with treatment was moderate, being TSQM-9 mean scores for effectiveness 64.2 [95% confidence interval (CI) 62.5-65.9], for convenience 75.8 (95% CI 74.2-77.3), and for global satisfaction 65.7 (95% CI 64.0-67.4). Global satisfaction was negatively associated with disease perception (β = -0.4709,  < 0.0001), and grade of dyspnea (β = -4.2564,  = 0.009). Satisfaction with treatment was lower in patients with poor compared with optimal adherence to treatment (β = -4.5608,  = 0.002). Changes in inhalation regimens during follow up did not modify the satisfaction with treatment.

Conclusions: The results of this real-life study showed that the patients' satisfaction with treatments is only moderate in COPD. A high grade of patients' satisfaction is associated mainly with a low perception of the disease, high adherence to treatment and lower level of dyspnea.

Trial Registration: Clinicaltrials.gov identifier: NCT02689492
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http://dx.doi.org/10.1177/1753466619888128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6878607PMC
June 2020

A Framework For Step Down Or Therapeutic Re-Organization For Withdrawal Of Inhaled Corticosteroids In Selected Patients With COPD: A Proposal For COPD Management.

Int J Chron Obstruct Pulmon Dis 2019 23;14:2185-2193. Epub 2019 Sep 23.

Department of Health Sciences, Università degli Studi di Milano,Pulmonary Unit, Luigi Sacco University Hospital, ASST Fatebenefratelli, Milan, Italy.

While chronic obstructive pulmonary disease (COPD) continues to be a major cause of morbidity and mortality, pharmacological therapy has a definite benefit on symptoms as well as the frequency and severity of exacerbations, and general health. The most recent Global Initiative for Obstructive Lung Disease (GOLD) guidelines recommend triple therapy (long-acting beta2 agonists [LABA] + long-acting muscarinic antagonists [LAMA] + inhaled corticosteroids [ICS]) only for patients with exacerbations, elevated eosinophils, and without control using a LABA/LAMA or ICS/LABA combination. Long-term monotherapy with ICS is not currently recommended, but may be considered in association with LABAs in patients with a history of exacerbations and elevated eosinophils in spite of appropriate treatment with long-acting bronchodilators. However, long-term use of ICS in combination therapy has been associated with adverse effects, even if widely used in routine management for decades. The available evidence suggests that ICS can be rationally discontinued in patients with stable disease and is not likely to have unfavorable effects on lung function, overall health, or be associated with a greater risk of exacerbations. Indeed, it is widely accepted that ICS therapy should be limited to a small proportion of patients after careful assessment of the individual risk-benefit profile. Unfortunately, however, there are no international recommendations that provide specific guidance or a protocol for withdrawal of ICS. Herein, the available evidence on the use of ICS is reviewed and an easy to use tool is proposed that can provide clinicians with a simple management scheme to guide the most appropriate therapy for management of COPD and use of ICS. In management of COPD, a highly personalized approach is advocated so that the most appropriate therapy for each individual patient can be selected.
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http://dx.doi.org/10.2147/COPD.S216059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6765263PMC
April 2020

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

COPD 2019 08 9;16(3-4):215-226. Epub 2019 Sep 9.

Cardiovascular and Thoracic Department, SC Pneumologia U, Città Della Salute e Della Scienza (Molinette) University Hospital , Turin , Italy.

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 plethysmography, DLCO, comorbidities, exacerbation history, pharmacological therapy and eosinophil counts were collected. A total of 1360 patients (73.4% males) were included in the analysis. Overall, 37% of the patients were severe-very severe according to GOLD 2007. Compared with GOLD 2011, applying the GOLD 2017 criteria, the proportion of the at risk categories (C and D) was reduced by ∼23%. Impairment in inspiratory capacity, DLCO and the prevalence of emphysema paralleled the GOLD 2007 classification only. The proportion of patients with ≥ 200 eosinophils/µL was higher in GOLD 2007 stages 3-4 compared with stages 1-2 ( = 0.008). Eosinophil levels were similar across risk classes in GOLD 2011 and 2017. Overall, 41.8% and 52.4% of the patients in the low risk groups according to GOLD 2011 and 2017 were exposed to inhaled corticosteroids. The GOLD 2011 and 2017 classifications, despite exploring symptoms and exacerbations, might miss other relevant patients' clinical characteristics such as lung function and phenotypes, which have a significant impact on outcomes and disease severity.
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http://dx.doi.org/10.1080/15412555.2019.1659760DOI Listing
August 2019

Mobile Technology in Allergic Rhinitis: Evolution in Management or Revolution in Health and Care?

J Allergy Clin Immunol Pract 2019 Nov - Dec;7(8):2511-2523. Epub 2019 Aug 21.

Charité-Universitätsmedizin Berlin, Berlin, Germany; Corporate member of Freie Universität Berlin, Humboldt-Uniersität zu Berlin, and Berlin Institute of Health, Comprehensive Allergy-Centre, Department of Dermatology and Allergy, Berlin, Germany; Member of GA(2)LEN, Berlin, Germany.

Smart devices and Internet-based applications (apps) are largely used in allergic rhinitis and may help to address some unmet needs. However, these new tools need to first of all be tested for privacy rules, acceptability, usability, and cost-effectiveness. Second, they should be evaluated in the frame of the digital transformation of health, their impact on health care delivery, and health outcomes. This review (1) summarizes some existing mobile health apps for allergic rhinitis and reviews those in which testing has been published, (2) discusses apps that include risk factors of allergic rhinitis, (3) examines the impact of mobile health apps in phenotype discovery, (4) provides real-world evidence for care pathways, and finally (5) discusses mobile health tools enabling the digital transformation of health and care, empowering citizens, and building a healthier society.
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http://dx.doi.org/10.1016/j.jaip.2019.07.044DOI Listing
October 2020

The unmet need for pertussis prevention in patients with chronic obstructive pulmonary disease in the Italian context.

Hum Vaccin Immunother 2020 6;16(2):340-348. Epub 2019 Sep 6.

Respiratory Unit, Department of Health of Sciences, ASST Santi Paolo e Carlo, University of Milan, Milan, Italy.

Despite high rates of vaccination, pertussis resurgence has been reported worldwide in recent years, including in Italy, especially in older adults.Chronic obstructive pulmonary disease (COPD) is a respiratory disease associated with progressive inflammation of the respiratory tract. Regional population studies have shown the prevalence of COPD in Italy to be approximately 15% with an age-dependent increase in proportion of COPD cases.Emerging data shows that individuals with COPD are at high risk of contracting pertussis. Furthermore, those who develop pertussis could experience exacerbation of their pre-existent COPD and further susceptibility to other infections.Immunization programs in Italy currently recommend a decennial reduced-antigen-content diphtheria-tetanus-acellular pertussis booster vaccine dose for adults. Active measures to encourage booster vaccination, especially for high-risk adults such as those with COPD, could positively impact pertussis morbidity and the associated healthcare burden.
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http://dx.doi.org/10.1080/21645515.2019.1652517DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7062424PMC
September 2019

Severe T2-high asthma in the biologics era: European experts' opinion.

Eur Respir Rev 2019 Jun 8;28(152). Epub 2019 Jul 8.

AstraZeneca, Luton, UK

The European Respiratory Biologics Forum gathered participants from 21 countries in Madrid, Spain, to discuss the management and treatment of severe asthma in the era of biologics. The current insights on the pathophysiology of severe asthma were discussed, as well as the role of respiratory biologics in clinical practice and strategies for eliminating chronic use of oral corticosteroids. The participants also highlighted the key challenges in identifying patients with severe asthma based on phenotypes, biomarkers and treatable traits, and the existing problems in patient referral to specialist care. The monitoring of treatment was debated and the need for a change towards precision medicine and personalised care was emphasised throughout the meeting. This review provides a summary of the discussions and highlights important concerns identified by the participants regarding the current management of severe asthma.
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http://dx.doi.org/10.1183/16000617.0054-2019DOI Listing
June 2019

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

Respir Med 2019 07 29;153:68-75. Epub 2019 May 29.

Studio di Economia Sanitaria, Milan, Italy.

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 institutions (90%; public university hospital: 30%). The total average cost of COPD was €2647.38/patient and ICS/LABA/LAMA therapy contributed the most (€1541.45). The average cost was €6206.19/patient for severe COPD (+139.67% vs the cost/patient with mild or moderate COPD). The regression model showed that, others things being equal, increases in the predicted average logged cost per patient were due to liquid oxygen therapy (+468.31%), three COPD exacerbations during the follow-up (+254.54%), and ICS/LABA or ICS/LABA/LAMA associated therapy (+59.26%). Moreover, a 1.19% increment was observed for each additional score of the CAT questionnaire. Conversely, a 36.52% reduction in the predicted average logged cost was reported for hospitals managed by local healthcare authorities.

Conclusions: The health econometric approach is innovative in the management of COPD patients in Italy. The results of the random effects log-linear panel data regression model may help clinicians estimate INHS costs when managing COPD patients. Clinicaltrials.gov ID# NCT02689492.
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http://dx.doi.org/10.1016/j.rmed.2019.05.017DOI Listing
July 2019

Minimal important difference of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL).

Allergy 2019 12 26;74(12):2542-2544. Epub 2019 Jun 26.

Dipartimento di Medicina Interna (DiMI), Università di Genova, Genova, Italy.

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http://dx.doi.org/10.1111/all.13939DOI Listing
December 2019

Diurnal mouthpiece ventilation and nocturnal non-invasive ventilation versus tracheostomy invasive ventilation in patients with amyotrophic lateral sclerosis.

Panminerva Med 2020 Mar 30;62(1):19-25. Epub 2019 May 30.

Unit of Pulmonary Rehabilitation, Don Gnocchi Foundation IRCCS, Milan, Italy.

Background: Respiratory disorders are a major cause of morbidity and mortality in amyotrophic lateral sclerosis (ALS). Current guidelines suggest the provision of noninvasive ventilation (NIV) for symptomatic hypoventilation in patients with ALS. Inspite of these results the proportion of ALS patients on tracheostomy invasive ventilation (TIV) is relatively high.

Methods: Thirty-two patients were included in the study: 16 patients were treated with nocturnal NIV associated with diurnal mouthpiece ventilation (MPV) and 16 with TIV .The primary endpoint of the study was to evaluate survival in the two groups. Secondary endpoints were to evaluate differences in the two populations in terms of clinical outcomes and quality of life (HRQoL).

Results: Cox analysis survival data shows no statically difference in the hazard function of the two groups. The comparison between the two groups showed a significant improvement in the average value of gas indices (paO2, paCO2) in the group treated with TIV in comparison to the group treated with MPV/NIV. Conversely, the evaluation of the questionnaires on HRQoL showed a higher score in patients treated with MPV/NIV compared to those treated with TIV.

Conclusions: Ventilatory treatment with MPV and TIV did not demonstrate significant differences in survival. Patients treated with MPV reported a better HRQoL, although TIV group showed higher ventilatory parameters improvement than MPV group.
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http://dx.doi.org/10.23736/S0031-0808.19.03644-9DOI Listing
March 2020

Patients beliefs on intravenous and subcutaneous routes of administration of biologics for severe asthma treatment: A cross-sectional observational survey study.

World Allergy Organ J 2019 28;12(4):100030. Epub 2019 Apr 28.

Department of Internal Medicine, Respiratory Diseases and Allergy Clinic, University of Genova, Azienda Policlinico IRCCs San Martino, Viale Benedetto XV, 6, 16132, Genoa, Italy.

Background: Understanding how patients generate preferences for administration route alternatives may improve health-care delivery and clinical outcomes. Recently, novel biological therapies with subcutaneous (SC) and intravenous (IV) administration routes have been approved for severe uncontrolled asthma. The aim of our study was to assess the preferred route of biologic therapy administration and related beliefs among patients with severe uncontrolled asthma.

Methods: We conducted a cross-sectional observational survey study. Patients answered an anonymous, self-administered questionnaire after an outpatient visit in pulmonary disease clinics located throughout Italy. Socio-demographic and clinical information together with the 12-Item Short Form Survey (SF-12), Work Productivity Impairment Scale and the medical resources utilization module of the Health & Work Survey were collected. Patients beliefs and preference towards SC and IV administration were investigated by means of an 13 item questionnaire.

Results The Main Findings: 150 patients fulfilled the inclusion criteria and completed the questionnaire (47.3% males). Preference for IV and SC administration was 18.7% and 81.3%, respectively. Compared with patients preferring SC formulation, patients that favored IV were older (p ​= ​0.04), less likely to escalate corticosteroid dose (p ​= ​0.03) and had emergency room (ER) access (p ​= ​0.009) during asthma exacerbations. Patients felt that SC was more convenient than IV, but this belief was not associated with higher likelihood of preferring SC administration. IV formulations were more likely associated with quicker and more effective drug action (p ​= ​0.0001), procedural safety and medical oversight (p ​= ​0.0002) and social support (p ​= ​0.007). Predictors of IV preference were represented by the association of worse asthma control and increased use of ER services, and by beliefs toward formulation effectiveness/efficiency in reducing symptoms (p ​= ​0.04 and p ​< ​0.0001, respectively). The model achieved excellent discrimination of administration route preference (area under the curve ​= ​0.87).

Conclusions: Preference is guided by partially misleading beliefs, which may generate wrong expectations that in turn can affect treatment satisfaction and adherence. Convenience and efficacy beliefs for drugs with different routes of administration always should be discussed with patients to achieve informed shared-decision making.

Trial Registration: Not applicable.
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http://dx.doi.org/10.1016/j.waojou.2019.100030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6488569PMC
April 2019

The cross-cultural validation of the English version of RhinAsthma patient's perspective (RAPP).

J Asthma 2020 06 25;57(6):680-686. Epub 2019 Mar 25.

Department of Internal Medicine, IRCCS San Martino di Genova University Hospital, Genoa, Italy.

No validated instrument is currently available in English for use in daily practice to assess Health Related Quality of Life (HRQoL) in asthma and comorbid allergic rhinitis (AR). The aim of this study was to validate and assess the psychometric characteristics of an English language version of RhinAsthma Patient Perspective (RAPP).: The study was performed in the Philippines. The RAPP was translated into English. Adult patients, diagnosed with asthma and AR, were recruited. Clinical and functional data were collected on two occasion with a 4-week interval between visits. At both visits patients completed the following questionnaires: RAPP, Short Form Heath Survey-12 (SF-12), asthma control test (ACT), and rhinitis symptom Visual Analog Scale (VAS). Scale dimensions, internal consistency and convergent validity, reliability, discriminant ability, responsiveness, and minimal important difference (MID) were evaluated. About 150 patients (mean age 39.3 years) completed the study. Exploratory and confirmatory factor analysis identified a uni-dimensional structure of the questionnaire. Internal consistency was satisfactory (0.87 at visit 1; 0.89 at visit 2). The tool showed good discriminant and convergent validity at both visits ( < 0.01). High reliability was confirmed by an ICC of 0.97 and a CCC of 0.95. Responsiveness was shown by a significant association with VAS ( = 0.34,  < 0.01) and ACT ( = -0.35,  < 0.01). The MID value was 2.: The English version of RAPP was shown to have good psychometric properties and is a valid tool for assessing asthma and AR HRQoL in clinical practice.
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http://dx.doi.org/10.1080/02770903.2019.1590595DOI Listing
June 2020

Non-invasive ventilation in acute respiratory failure of patients with obesity hypoventilation syndrome.

Minerva Med 2018 Dec;109(6 Suppl 1):1-5

Unit of Respiratory Diseases and Allergies, Department of Internal Medicine (DiMI), San Martino University Hospital, Genoa, Italy.

Introduction: Non-invasive ventilation (NIV) has been used successfully for the management of acute respiratory failure (ARF) more often in the last two decades compared to prior decades. There are particular groups of patients that are more likely to benefit from NIV. One of these groups is patients with obesity hypoventilation syndrome (OHS). The aim of this review is to evalue the effectiveness of NIV in acute ARF.

Evidence Acquisition: MEDLINE, EMBASE, CINHAIL, Cochrane Central Register of Controlled Trials, DARE, the Cochrane Database of Systematic Reviews, and the ACP Journal Club database were searched from January 2001 to December 2017.

Evidence Synthesis: More than 30% of them have been diagnosed when hospitalized for ARF. NIV rarely failed in reversing ARF. OHS patients who exhibited early NIV failure had a high severity score and a low HCO3 level at admission; more than half of hypercapnic patients with decompensated OHS exhibited a delayed but successful response to NIV.

Conclusions: Patients with decompensation of OHS have a better prognosis and response to NIV than other hypercapnic patients. They required more aggressive NIV settings, a longer time to reduce paCO2 levels, and showed more frequently a delayed but successful response to NIV.
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http://dx.doi.org/10.23736/S0026-4806.18.05921-9DOI Listing
December 2018