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Importance: Evidence of effective smoking cessation interventions in patients with diabetes is limited. The unique behavioral and metabolic characteristics of smokers with type 2 diabetes warrants a randomized clinical trial of the smoking cessation drug varenicline. Objective: To evaluate the efficacy and safety of varenicline in patients with type 2 diabetes with an intention to quit smoking. Design, setting, and participants: This multicenter, double-blind, placebo-controlled randomized clinical trial recruited patients from 6 outpatient clinics in 5 hospitals in Catania, Italy. Patients with type 2 diabetes, who were smoking at least 10 cigarettes a day, and who intended to quit smoking were screened for eligibility. Eligible patients were randomized to either varenicline or placebo treatment. The trial consisted of a 12-week treatment phase followed by a 40-week follow-up, nontreatment phase. Intention-to-treat data analysis was performed from December 2020 to April 2021. Interventions: Varenicline, 1 mg, twice daily or matched placebo administered for 12 weeks. Patients in both treatment groups also received smoking cessation counseling. Main outcomes and measures: The primary efficacy end point of the study was the continuous abstinence rate (CAR) at weeks 9 to 24. Secondary efficacy end points were the CAR at weeks 9 to 12 and weeks 9 to 52 as well as 7-day point prevalence of abstinence at weeks 12, 24, and 52. Results: A total of 300 patients (mean [SD] age, 57.4 [0.8] years; 117 men [78.0%] in varenicline group and 119 men [79.3%] in placebo group) were randomized to receive varenicline (n = 150) or placebo (n = 150). The CAR at weeks 9 to 24 was significantly higher for the varenicline than placebo group (24.0% vs 6.0%; odds ratio [OR], 4.95; 95% CI, 2.29-10.70; P < .001). The CARs at weeks 9 to 12 (31.3% vs 7.3%; OR, 5.77; 95% CI, 2.85-11.66; P < .001) and weeks 9 to 52 (18.7% vs 5.3%; OR, 4.07; 95% CI, 1.79-9.27; P < .001) as well as the 7-day point prevalence of abstinence at weeks 12, 24, and 52 were also significantly higher for the varenicline vs placebo group. The most frequent adverse events occurring in the varenicline group compared with the placebo group were nausea (41 [27.3%] vs 17 [11.4%]), insomnia (29 [19.4%] vs 19 [12.7%]), abnormal dreams (19 [12.7%] vs 5 [3.4%]), anxiety (17 [11.4%] vs 11 [7.3%]), and irritability (14 [9.4%] vs 8 [5.4%]). Serious adverse events were infrequent in both groups and not treatment-related. Conclusions and relevance: Results of this trial showed that inclusion of varenicline in a smoking cessation program is efficacious in achieving long-term abstinence without serious adverse events. Varenicline should be routinely used in diabetes education programs to help patients with type 2 diabetes stop smoking. Trial registration: ClinicalTrials.gov Identifier: NCT01387425.

Study Objectives: Patients with chronic kidney disease (CKD) often report poor sleep quality, but they commonly exhibit OSA. The aim of this study was to evaluate the influence of OSA severity and of estimated glomerular filtration rate impairment on objective sleep quality in nondialyzed patients with CKD, defined as an estimated glomerular filtration rate

Asthma may have an impact on lung function decline but conflicting results are reported in forced expiratory volume in one second (FEV) decline. We aimed to describe the changes in FEV in lifelong non-smoking adult asthmatic outpatients during a 10-year follow-up comparing years 1-5 (1st period) with years 6-10 (2nd period) to assess factors affecting these changes. A total of 100 outpatients performed spirometry every 3 months during a 10-year survey. FEV/Ht slope values of the 2nd period reduced significantly respect to the 1st period (p < 0.0001). FEV slopes of years 1-5 and 6-10 were inversely associated with FEV at enrolment (p = 0.02, p = 0.01, respectively). Reversibility and variability FEV showed a significant effect on the 1st period slopes (p = 0.01 and p < 0.04, respectively). Frequent exacerbators in the 1st year had steeper FEV/Ht slopes in the 1st period (p = 0.01). The number of subjects using higher doses of ICS was significantly lower at the 10th years respect to the 5th and the 1st year (p < 0.001, p = 0.003, respectively). This study shows that FEV decline in treated adult asthmatics non-smokers, over 10-year follow-up, is not constant. In particular, it slows down over time, and is influenced by FEV at enrolment, reversibility, variability FEV and exacerbation score in the 1st year.

Background: After the global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), research has highlighted several aspects of the pandemic, focusing on clinical features and risk factors associated with infection and disease severity. However, emerging results on the role of smoking in SARS-CoV-2 infection susceptibility or Novel Coronavirus Disease 2019 (COVID-19) outcomes are conflicting, and their robustness remains uncertain. Objective: In this context, this study aims at quantifying the proportion of SARS-CoV-2 antibody seroprevalence, studying the changes in antibody levels over time, and analyzing the association between the biochemically verified smoking status and SARS-CoV-2 infection. Methods: The research design involves a 6-month prospective cohort study with serial sampling of the same individuals. Each participant will be surveyed about their demographics and COVID-19- related information, and blood sampling will be collected upon recruitment and at specified follow-up time points (namely, after 8 and 24 weeks). Blood samples will be screened for the presence of SARS-CoV-2 specific antibodies and serum cotinine, being the latter the principal metabolite of nicotine, which will be used to assess participants' smoking status. Results: The study is ongoing. It aims to find a higher antibody prevalence in individuals at high-risk for viral exposure (i.e., healthcare personnel), and to refine current estimates on the association between smoking status and SARS-CoV-2/COVID-19. Conclusions: The added value of this research is that the current smoking status of the population to be studied will be biochemically verified, in order to avoid the bias associated with self-reported smoking status. As such, the results from this survey may provide actionable metric to study the role of smoking in SARS-CoV-2 infection and COVID-19 outcomes, and therefore implement the most appropriate public health measures to control the pandemic. Results may also serve as a reference for future clinical research and the methodology could be exploited in public health sectors and policies.

Excessive daytime sleepiness (EDS) is a symptom of obstructive sleep apnea (OSA) that resolves under treatment with continuous positive airway pressure (CPAP). In some patients, sleepiness persists despite CPAP treatment. We retrospectively analyzed data on subjective residual EDS, assessed as an Epworth Sleepiness Scale score (ESS) >10, in patients from the European Sleep Apnea Database (n = 4,853, mean age ± SD 54.8 ± 11.8 years, 26.1% females), at baseline and at the first visit (median follow-up: 5 months, interquartile range 3–13). An ESS > 10 occurred in 56% of patients at baseline and in 28.2% of patients at follow-up. Residual EDS was analyzed in 2,190 patients (age: 55.1 ± 12.0 years, 26.1% females) with sleep monitoring data (median follow-up: 3 months, interquartile range 1–15). Sleep studies during CPAP use were obtained in 58% of these patients; EDS was reported by 47.2% of patients at baseline and by 30.3% at follow-up. Residual OSA, defined as an apnea–hypopnea index >10/h, and insufficient CPAP adherence, defined as nightly use 10 at the first follow-up visit was associated directly with ESS at baseline and inversely with duration of follow-up, and CPAP use (R2 of the model: 0.417). EDS showed heterogeneity in different European countries both at baseline and at the first follow-up visit, suggesting modulation by cultural and lifestyle factors. In conclusion, residual EDS in CPAP-treated OSA occurred in approximately one in four patients at follow-up; its prevalence was highest (40%) in the first 3 months of treatment and subsequently decreased. The finding of residual EDS in a significant percentage of optimally treated OSA patients suggests that wake-promoting agents may be useful, but their indication should be evaluated after at least 3 months of treatment. © Copyright © 2021 Bonsignore, Pepin, Cibella, Barbera, Marrone, Verbraecken, Saaresranta, Basoglu, Trakada, Bouloukaki, McNicholas, Bailly, Pataka, Kvamme, Hein, Mihaicuta, Grote, Fanfulla and ESADA Study Group.

Il capitolo è la sintesi delle attività sviluppate all'interno del progetto CISAS per quanto attiene lo studio del microbioma umano e le influenze che l'ambiente può avere su di esso. Il capitolo fornisce al lettore numerosi spunti sulle relazioni tra microbioma e salute umana, tracciando i possibili scenari di sviluppo di tecnologie non invasive per lo studio delle comunità batteriche che popolano l'intestino umano.

Substantial knowledge is available on the association of the indoor school environment and its effect among schoolchildren. In the same context, the SINPHONIE (School indoor pollution and health: Observatory network in Europe) conducted a study to collect data and determine the distribution of several indoor air pollutants (IAPs), physical and thermal parameters and their association with eye, skin, upper-, lower respiratory and systemic disorder symptoms during the previous three months. Finally, data from 115 schools in 54 European cities from 23 countries was collected and included 5175 schoolchildren using a harmonized and standardized protocol. The association between exposures and the health outcomes were examined using logistic regression models on individual indoor air pollutants (IAPs); a VOC (volatile organic compound) score defined as the sum of the number of pollutants to which the children were highly exposed (concentration > median of the distribution) in classroom was also introduced to evaluate the multiexposure – outcome association, while adjusting for several confounding factors. Schoolchildren exposed to above or equal median concentration of PM2.5, benzene, limonene, ozone and radon were at significantly higher odds of suffering from upper, lower airways, eye and systemic disorders. Increased odds were also observed for any symptom (sick school syndrome) among schoolchildren exposed to concentrations of limonene and ozone above median values. Furthermore, the risks for upper and lower airways and systemic disorders significantly increased with the VOCs score. Results also showed that increased ventilation rate was significantly associated with decreased odds of suffering from eye, skin disorders whereas similar association was observed between temperature and upper airways symptoms. The present study provides evidence that exposure to IAPs in schools is associated with allergic and respiratory symptoms in children. Further investigations are needed to confirm our findings. © 2020 Elsevier B.V.

Background Indoor allergens are risk factors for asthma: Thus, the characterization of indoor air quality is important for studying environment–health relationships in children. In particular, Dermatophagoides pteronyssinus is the dominant allergen for asthma. We cross-sectionally investigated the relationships among respiratory symptoms and function, airway inflammation, allergen sensitization, and indoor allergen concentration. Methods One hundred and thirty-two children aging 10-14 years and living in a Southern Mediterranean area were evaluated by parental questionnaires. Spirometry, exhaled nitric oxide (FeNO), skin prick tests, total, and specific serum IgE analyses were performed along with the evaluation of home dust samples for the content in Der p 1 allergen. Three clusters were created on the basis of the presence/absence of wheeze in the last 12 months (Wh12m) and Der p 1-specific IgE level. Results Cluster 1 (Wh12m+/high Der p 1 IgE) presented higher FeNO and poorer pulmonary function (lower FEV1 and FEF25%-75%), while its symptom score was not different from Cluster 2 (Wh12m+/low Der p 1 IgE). Cluster 3 (Wh12m−/low IgE) showed the lowest FeNO values and pulmonary function similar to Cluster 2. Within Cluster 1, both Der p 1-specific IgE and FeNO were positively correlated with dust Der p 1. Conclusions Similar asthma phenotypes may occur in children despite differences in their atopic state. In atopic children, sensitizing allergens in the indoor environment may increase airway inflammation worsening pulmonary function. Moreover, environmental exposures may contribute to the development of asthma-like symptoms also in the absence of atopic sensitization, thus contributing to asthma overdiagnosis.

Il diritto a respirare aria sana nelle scuole è stato sancito già nell’anno 2001 in un documento dell’European Federation of Asthma and Allergy Associations che ha evidenziato scarsa attenzione e assenza di direttive specifiche dell’Unione Europea relativamente agli effetti sulla salute da inquinamento dell’aria nelle scuole, ed è sostenuto dal numero enorme di bambini e ragazzi che frequentano le aule scolastiche. Negli ultimi anni, a livello europeo si è sviluppato un sempre crescente interesse nei confronti dell’effetto della qualità dell’aria dell’indoor scolastico (IAQ) sulla salute dei ragazzi, e sono stati avviati numerosi progetti di ricerca internazionali mirati, appunto, a determinare l’effetto di una cattiva IAQ sulla salute. Il progetto THADE (Towards Healthy Air in Dwellings in Europe), concluso nel 2006, ha prodotto raccomandazioni per un programma europeo sulla qualità dell’aria negli ambienti confinati, tra le quali il controllo della ventilazione e dell’umidità degli edifici per la prevenzione della formazione di muffe. Lo studio HESE (Health Effects of School Environment) ha raccolto per la prima volta nel 2004-2005 informazioni comparabili sulla IAQ di aule in diversi Paesi europei (in Italia, 8 scuole a Siena ed 8 ad Udine) e sulla salute respiratoria dei bambini (242 italiani), evidenziando una cattiva IAQ nelle scuole italiane a causa dei livelli elevati di PM10 e CO2 essenzialmente per l’assenza di un’adeguata ventilazione, e ne ha mostrato effetti sulla salute respiratoria dei bambini. Lo studio HESEINT (Interventions on Health Effects of School Environments), attualmente in corso, prosecuzione del precedente HESE, intende contribuire alla tutela della salute dei bambini europei, incrementando la consapevolezza delle autorità scolastiche per la IAQ con interventi basati su prove scientifiche di efficacia. Lo studio EnVIE (European Coordination Action for Indoor Air Quality and Health Effects), un’azione mirata ad interfacciare scienza e politiche di intervento nel campo della IAQ, ha indicato le principali patologie condizionate dall’esposizione a fattori di rischio indoor proponendo strategie da adottare per ridurne l’impatto sulla salute. Lo studio europeo SEARCH (School Environment And Respiratory health in CHildren), che ha visto raccogliere, in Italia, misurazioni ambientali ed informazioni sulla salute respiratoria in circa 1000 bambini di scuole in Lombardia, Piemonte, LXVIII.1.2012 • 121 LA QUALITÀ DELL'ARIA INDOOR NELLE SCUOLE: RISCHI PER MALATTIE RESPIRATORIE E ALLERGICHE QUADRO CONOSCITIVO DELLA SITUAZIONE ITALIANA E STRATEGIE DI PREVENZIONE Igiene e Sanità Pubblica - Atti del Workshop Lazio, Sardegna e Sicilia, ha ulteriormente confermato la scarsa qualità dell’aria all’interno delle aule. La prevenzione ed il controllo delle patologie correlate agli ambienti indoor sono obiettivi prioritari della Strategia per l’ambiente e salute dell’Unione Europea: l’iniziativa “SCALE” (Science, Children, Awareness, Legal instrument, Evaluation) identifica come prioritaria, per lo sviluppo umano ed economico, la protezione della salute dei bambini dalle minacce dell’ambiente, compresi gli ambienti indoor. Tale strategia è stata anche sviluppata nella recente Fifth Ministerial Conference on Environment and Health organizzata dall’OMS - Regione Europea (Parma, marzo 2010). Tutto ciò ha contribuito alla produzione, da parte dell’OMS, di linee guida per la prevenzione di umidità e muffe negli ambienti indoor (2009) e, più in generale, sulla IAQ (2010). A livello Italiano, un programma di prevenzione per gli ambienti indoor è previsto nelle “Linee Guida per la tutela e la promozione della salute negli ambienti confinati” (Accordo tra Ministro della Salute, Regioni e Province autonome - G.U. del 27 novembre 2001, n.276, SO n. 252), mentre, dopo una lunga gestazione nell’ambito della Conferenza Stato-Regioni, sulla GURI n. 9 del 13 gennaio 2011 è stato pubblicato lo “Schema di linee di indirizzo per la prevenzione nelle scuole dei fattori di rischio indoor per allergie e asma”. Contestualmente, la componente italiana dell’Alleanza Globale contro le Malattie Respiratorie croniche (GARD) ha istituito nel marzo 2010 un gruppo di lavoro per definire un “Programma di prevenzione per le scuole dei rischi indoor per malattie respiratorie e allergiche”. Sulla stesa linea si pone il progetto paneuropeo “SINPHONIE” (Schools Indoor Pollution and Health: Observatory Network in Europe), attualmente in corso, che dovrà produrre linee guida sulle possibili misure di intervento per migliorare la qualità dell’IAQ scolastica nei diversi contesti nazionali, diffondendole agli stakeholder locali. Ancora, altro progetto sviluppato a livello internazionale nell’ambito del PO Italia-Malta 2007-2013, è “RESPIRA” (Indoor and Outdoor Air Quality and Respiratory Health in Malta and Sicily) mirato alla contemporanea valutazione degli effetti dell’IAQ scolastica e domestica e della qualità dell’aria outdoor su campioni di popolazione di Malta e della Provincia siciliana di Caltanissetta. Tra le iniziative sviluppate a livello locale, vanno ricordati gli studi condotti su un ampio campione di studenti di Scuola Secondaria di primo Grado tra il 2005 e il 2009 a Palermo, che hanno fornito dati sull’effetto dell’indoor domestico sulla salute respiratoria degli adolescenti. Rimane però immutata la necessità di penetrare nelle dinamiche delle politiche locali, al fine di far sì che, dalle dimostrazioni scientifiche degli effetti nocivi sulla salute di una cattiva IAQ, si passi ai necessari interventi. A tale riguardo, il progetto CCM 2010 “Indoor-School” (Esposizione ad inquinanti indoor: linee guida per la valutazione dei fattori di rischio in ambiente scolastico e definizione delle misure per la tutela della salute respiratoria degli scolari e degli adolescenti), sviluppato in sette diverse Regioni italiane è stato designare l’effetto sulla salute dei ragazzi e sull’IAQ delle scuole dell’implementazione delle linee guida esistenti sull’indoor scolastico

Large variations in prevalence of atopy and allergic diseases are reported worldwide in children, but in epidemiological studies the use of skin prick tests (SPT) and spirometry along with questionnaires is not common in the Mediterranean Area. The present work was aimed at evaluating the prevalence of current asthma (CA), rhinoconjunctivitis (RC), and eczema (E), with atopy and respiratory function, and the role of risk factors for allergic respiratory diseases. A total of 2150 Italian schoolchildren were cross-sectionally investigated through respiratory questionnaire, SPT, and spirometry. A proportional Venn diagram quantified the distribution of CA, RC, and E, stratifying for allergic sensitization to show differences in prevalence of allergic diseases among subjects with and without positive SPT. CA prevalence was 4.2%, RC 17.9%, and E 5.3%. CA and RC increased, while E decreased, with respect to previous local studies. Allergic sensitization prevalence (evaluated as positive response to at least one SPT) was 39.2%. A double Venn diagram identified 15 categories. Atopic CA was threefold more frequent than non-atopic CA. Atopic vs non-atopic RC and E were 9.6% vs 10.3% and 2.0% vs 3.3%, respectively. Atopic vs non-atopic RC associated with CA were 1.6% vs 0.5%; the same figures for RC associated with E were 0.8% vs 1.3%. Asymptomatic atopic subjects were 27.0%. Atopy, RC, parental asthma, and environmental risk factors were associated with CA. Atopy and environmental factors were risk factors also for RC. Asthma and traffic exposure were linked to reduced lung function. Respiratory allergic diseases are still increasing and largely concomitant in Italian adolescents. Atopy is more important for CA than RC. Avoiding exposures to measured environmental risk factors would prevent 41% of current asthma and 34% of rhinoconjunctivitis.

The extent to which the sensitization to the German cockroach Blattella germanica (BG) affects onset/presence of rhinoconjunctivitis (RC) in children is unknown.

A causal relationship between earth material and human health, although not always proven, is highly plausible because many chemical elements in rocks and soils are directly inhaled by respiration or transmitted, via air, water and vegetation, into food chain and then to human body. It is well known that metals and metalloids may result essential to biochemical and physiological functions, but it is also well known that health problems may derive from either dietary deficiencies or excesses. Among the techniques employed to assess the exposure of living organisms to metals and metalloids present in the environment, the human biomonitoring has attracted the attention of investigators over the past decades. More specifically, the human biomonitoring is a method for assessing human exposure to chemicals by measuring the searched chemicals or their metabolites in human tissues or specimens, such as blood, plasma, serum, breast milk, urine, teeth and also hairs. However, some of these specimens may not always be the best indicators of element intake because of the homeostatic system of control in the human body. Human hairs seem to be particularly appropriate as they offer several advantages. Hair are stable and their composition does not change over short time period. Furthermore, sampling procedure is very easy, requires no specific professional skills, is painless and non-invasive. The present study deals with the trace elements content of hair samples from the scalp of 136 young students, between 11 and 14 years of age, of female and male gender, resident in the metropolitan area of Palermo (80 samples) and in a small rural town, Altavilla (56 samples), 20 km far from Palermo. The concentrations of 18 elements (Al, As, Ba, Cd, Co, Cr, Cu, Li, Mn, Mo, Ni, Pb, Sb, Se, Sr, U, V, Zn) in hair were determined by ICP-MS. In order to eliminate external contamination, each hair sample was firstly properly washed. The obtained results were in line with the ranges of values published in other studies. The most abundant elements resulted Zn, Cu, Al, Sr, Ba, Pb in Palermo as well as in Altavilla, although with different abundance orders. All the remaining analyzed elements were below 1 ppm. Zn is known to be an essential element recognized in more than 300 enzymes depending on this element for catalytic, structural, and regulatory functions. Cu is considered an indispensable catalytic cofactor in redox chemistry for proteins. Al and Sr are typical geogenic elements; their different abundances in the Palermo and Altavilla samples are related to the different lithological site, carbonate rocks in Palermo and calcarenites-clays at Altavilla. Sr is also strictly related to calcium content in bones. The highest levels of most elements were found in Altavilla samples: this may indicate a possible different exposure due to different lifestyles, as evidenced by Al and Pb. In fact, children living at Altavilla spend more time outdoors than those living in Palermo. The higher Ba concentration in children from Altavilla may be also related to the Ba content of local drinkable water. Significant gender-related differences were found for certain elements. This was the case of Sr and Zn, more abundant in female subjects, and Cr, Li, Pb, Sb and U which were more abundant in males. When the elements are subdivided in essential and not essential, and their ratios with respect to aluminum are compared with those in air particulate matter and road dust, it appears evident that some elements typical of anthropogenic sources (Cd, Pb e Sb) are taken by PM10-2.5, PM2.5 and the finest fractions of road dust. Data concerning subjects exposed and not exposed to passive smoke are also reported. Further, it has been examined the relationship between exposure to passive smoke and concentration of nicotine (and its metabolite cotinine) in hairs. A first result of this work is that the reported data and concentration ranges can be used as guidelines for to evaluate environmental or occupational exposure to these elements.

An increased prevalence of bronchial hyper-responsiveness (BHR) has been demonstrated in children from a general population, and in non-asthmatic adults with allergic rhinitis. Thus, also children with allergic rhinitis are expected to be at higher risk of BHR. We evaluated the prevalence of BHR in a sample of non-asthmatic children with allergic rhinitis by means of the methacholine (Mch) bronchial challenge, and by monitorizing the airway patency using the daily peak expiratory flow variability (PEFv). Fifty-one children (ranged 6-15 years of age) with allergic rhinitis, ascertained by skin prick test to inhalant allergens, underwent a 14-day peak expiratory flow monitoring, and a Mch bronchial provocation challenge. Thirty healthy children matched for age, and sex served as control group. Thirty-one children in the rhinitis group (61%), and six (20%) in the control group were Mch+ (Mch provocative dose causing a 20% fall of forced expiratory volume in 1 s respect to baseline

Road traffic is assumed to be a major risk factor for respiratory diseases. CNR performed a project to analyse the effects of traffic on a sample of students of Palermo (Italy). An epidemiological survey was conducted in several schools, also by means of a questionnaire. Information on health status, as well as life style and individual perception of exposure, were gathered. A simulation model to assess road traffic was developed and an estimated mean number of vehicles travelling on each road tract was obtained. Mapping of subjects and of schools was performed by GPS; acquired points were integrated in numeric cartography. Estimated road traffic values around subjects' residences and around schools were then used to compute each subject exposure, taking care of the percentage of time spent at home or at school. Finally, subjects were classified into four classes, depending on individual exposure, and statistical analysis was conducted on main respiratory symptoms and diseases. No statistically significant association was found between traffic exposure and respiratory symptoms or diseases.