Background: Although general practitioners (GPs) are frequently the first healthcare professionals whom asthma patients refer to for their symptoms, few studies have explored the extent of adherence to guidelines for asthma management based on data provided directly by GPs. Aims of the present study were to assess drug prescriptions for asthma by GPs and to evaluate prescriptive adherence to GINA guidelines (GL) and its relationship with disease control in real life. Methods: 995 asthmatic patients (45% males, mean age 43.3 +/- 17.7 yrs) were enrolled by 107 Italian GPs distributed throughout the country. Data on diagnosis, disease severity, prescribed anti-asthmatic drugs and control were collected through questionnaires filled out by GPs taking into consideration the 2009 GINA Guidelines. Data on drug use and chronic sinusitis, nasal polyposis, chronic bronchitis, emphysema were reported by patients through a self-administered questionnaire. Results: The large majority of patients were classified by GPs as having intermittent (48.4%) or mild persistent asthma (25.3%); 61% had co-morbid allergic rhinitis (AR). The prevalent therapeutic regimen used by patients was a combination of inhaled corticosteroids (ICS) plus long-acting beta(2)-agonists (LABA) (54.1%), even in the intermittent/mild persistent group. ICS as mono-therapy or in combination with other drugs but LABA, was the second most frequently adopted treatment (14.4%). In general, the GPs adherence to GL treatment indications was 28.8%, with a significant association with a good asthma control (OR 1.85, 95% CI 1.18-2.92). On the other hand, comorbidity (OR 0.52, 95% CI 0.32-0.84), moderate (0.44, 0.28-0.69) and severe (0.06, 0.02-0.20) persistent asthma showed significant negative effects on asthma control. Conclusions: Our results show that over-treatment of intermittent/mild persistent asthma is frequent in the GPs setting while therapeutic regimens are more appropriately applied for moderate/severe asthma. In general, we found low adherence to GINA GL treatment recommendations even if its relevance in asthma control was confirmed.

Rationale: in recent decades, there has been an increase in the prevalence of allergic respiratory diseases. Aim: to evaluate the role of atopy as a risk factor for developing allergic respiratory diseases in an Italian general population sample surveyed twice 18 years apart. Methods: a general population sample participated in a prospective cohort study carried out in Pisa in 1991-93 (n=2841) and 2009-11 (n=1620). 987 subjects participated in both surveys completing twice a standardized questionnaire on health status and risk factors and undergoing prick tests at baseline. By logistic regression models we assessed the association of atopy (skin test positivity (STP): wheal >5mm) with incidence of allergic respiratory diseases, adjusting for: age, sex, exposure to environmental pollution sources, urban/suburban residence, asthma familiarity, allergic rhinitis familiarity. Results: STP prevalence was 17.5%, mainly to pollens (9.5%) and dust mites (8.1%). Allergic rhinitis (AR) and AR symptoms incidence were significantly linked to cumulative SPT [OR 5.40 (95% CI 3.06-9.55) and 2.00 (1.28-3.13), respectively], to pollen STP [3.55 (1.53-8.23) and 2.37 (1.18-4.75), respectively] and to moulds STP [5.95 (1.58-22.45) for only AR). Asthma diagnosis/symptoms incidence was significantly linked to dust mites STP [2.81 (1.09-7.23)]. Conclusions: our longitudinal study shows that atopic sensitization is a predictive factor of the risk of developing allergic respiratory diseases, with seasonal allergens linked to AR and perennial allergens (dust mites) to asthma. These results may be useful for preventive strategies.

Background: work exposure to fumes/gases/chemicals is associated with COPD symptoms/diagnosis but few epidemiological surveys on general population samples estimated such relationship over a long time interval. Objectives: to assess the association between long term work exposure to fume/gas/chemicals and COPD symptoms/diagnosis over a 20 yrs period. Methods: a general population sample participated in 2 surveys carried out in Pisa in 1991-93 and 2009-11. A standardised questionnaire on health status and risk factors was used. Chi-square test was used to compare long term work exposure [ever exposed (EE), at least once exposed (ATOE), never exposed (NE)] and the change in COPD symptoms/diagnosis from the 1st to the 2nd survey (COPD symptoms: persistent/incident vs never/remittent; COPD diagnosis: persistent/incident vs never/remittent). Logistic regression models (LRM) were run to analyse the association between persistent/incident COPD symptoms/diagnosis and work exposure adjusted for gender, age, smoking habits, asthma symptoms/diagnosis at the 1st survey, smoking habits and lifetime passive smoke exposure. Results: there were 1107 longitudinal subjects: 27.5% EE, 30.4% ATOE and 42.1% NE. LRM showed a significantly higher risk of having persistence/onset of: COPD diagnosis (OR=2.4, 95%CI=1.4-3.9), dyspnoea (OR=2.0, 95%CI=1.4-2.9), usual phlegm (OR=2.2, 95%CI=1.5-3.3), usual cough (OR= 1.6, 95%CI=1.0-2.3), in EE; dyspnoea (OR=1.7, 95%CI=1.2-2.3), usual phlegm (OR=1.5, 95%CI=1.1-2.2) in ATOE. Conclusions: our findings indicate a longitudinal association between work exposure and COPD. There is a need for the EU to implement effective strategies for COPD prevention in work settings.

Background: application of international guidelines is expected to guarantee a better disease management and control in asthmatic patients. Aim: to assess the association between not appropriate treatment and disease control outcomes in outpatients, through implementation of the on-line Italian Registry of severe/not controlled asthma (SNCA). Methods: longitudinal observational study in Italian specialistic centres on SNCA patients. Pulmonologists collected information on asthma control, management and risk factors at baseline and during the control visit. Data were directly entered via web in the on-line Registry. SNCA treatment was considered appropriate if used drugs were conform with pharmacological treatment recommended in the GINA guidelines. To assess the effects of a not appropriate treatment over time, the relationship between subjects with a longitudinal appropriate (LA)/not appropriate (LNA) treatment and follow-up control outcomes was analyzed using univariate and multivariate analyses (adjusting for age, sex, BMI). Results: the Registry contains information on 195 longitudinal cases: 45 (23.1%) LNA. Through logistic regression model, being LNA vs being LA was significantly associated with the following indicators of uncontrolled asthma: not/partially controlled asthma (OR 12.6, 95% CI 1.8-86.1), >2 times oral steroids use (7.7, 1.1-54.3) and hospitalizations (14.4, 1.4-144.3). There was a borderline relation with: >1 exacerbation (2.6, 0.9-7.8), emergency department visits (11.4, 0.7-175.2). Conclusions: within the Italian SNCA registry, a not appropriate treatment is related to lower disease control. Funded by Italian Medicines Agency (AIFA), Independent Research Contract FARM8YRYZC.

Background: Few epidemiological surveys on general population samples estimated changes in prevalence of respiratory symptoms/diseases over a long time interval; our study aims to quantify the temporal changes in the prevalence rates of asthma, allergic rhinitis and Chronic Obstructive Pulmonary Disease (COPD) after 25 years from baseline.Methods: A general population sample participated in 3 cross-sectional surveys carried out in Central Italy (Pisa) in 1985-88 (n = 3865), 1991-93 (n = 2841), 2009-11 (n = 1620). 2276 (47%) subjects participated in at least 1 survey, 1723 (35.5%) in at least 2 surveys and 849 (17.5%) in all the 3 surveys. All subjects filled in a standardized questionnaire about health status and risk factors; a sub-sample performed spirometry.Chi-square test was used to compare adjusted prevalence rates of respiratory symptoms/diseases and descriptive characteristics among the surveys. Generalised estimating equations (GEE) were used to analyze the association between respiratory symptoms/diseases and risk factors.Results: There was an increasing trend in prevalence rates of all respiratory symptoms/diseases throughout the surveys: current asthma attacks (1st-3rd survey prevalence: 3.4-7.2%), allergic rhinitis (16.2-37.4%), usual phlegm (8.7-19.5%) and COPD (2.1-6.8%) more than doubled. The GEE model confirmed these increasing trends, indicating higher risk of having respiratory symptoms/diseases in the second and third surveys.Conclusions: While asthma and allergic rhinitis increasing trends were confirmed, with respect to other international studies, also a COPD increasing prevalence rates was shown. (C) 2015 Elsevier Ltd. All rights reserved.

BACKGROUND:Few epidemiological surveys on general population samples estimated changes in prevalence of respiratory symptoms/diseases over a long time interval; our study aims to quantify the temporal changes in the prevalence rates of asthma, allergic rhinitis and Chronic Obstructive Pulmonary Disease (COPD) after 25 years from baseline. METHODS:A general population sample participated in 3 cross-sectional surveys carried out in Central Italy (Pisa) in 1985-88 (n = 3865), 1991-93 (n = 2841), 2009-11 (n = 1620). 2276 (47%) subjects participated in at least 1 survey, 1723 (35.5%) in at least 2 surveys and 849 (17.5%) in all the 3 surveys. All subjects filled in a standardized questionnaire about health status and risk factors; a sub-sample performed spirometry. Chi-square test was used to compare adjusted prevalence rates of respiratory symptoms/diseases and descriptive characteristics among the surveys. Generalised estimating equations (GEE) were used to analyze the association between respiratory symptoms/diseases and risk factors. RESULTS:There was an increasing trend in prevalence rates of all respiratory symptoms/diseases throughout the surveys: current asthma attacks (1st-3rd survey prevalence: 3.4-7.2%), allergic rhinitis (16.2-37.4%), usual phlegm (8.7-19.5%) and COPD (2.1-6.8%) more than doubled. The GEE model confirmed these increasing trends, indicating higher risk of having respiratory symptoms/diseases in the second and third surveys. CONCLUSIONS:While asthma and allergic rhinitis increasing trends were confirmed, with respect to other international studies, also a COPD increasing prevalence rates was shown.

Background: Recently, there has been a growing interest about the emission of unpleasant odors due to their potential health impacts. Aim: to evaluate the associations between odor annoyance perception and health in neighbors of Pisa waste incinerator. Methods: the circular study area, centered on the incinerator, was divided in 5 rings, with radius 0.4, 0.8, 1.4, 2.7, 4.0, for sampling subjects according to household residence. Controls were randomly chosen outside the study area. 1407 subjects filled out a self-administered standardized questionnaire on respiratory symptoms/diseases, cancer, cardiovascular diseases, risk factors and odor annoyance levels (no, slightly annoying, very annoying). Results: prevalence rates of odor annoyance perception in 1407 subjects participating in the survey (50% males, mean age 44 ± 22 yrs) were: 39.8% no odor perceived;19.1% slightly annoying odors; 41.2% very annoying odors. By multivariate analysis, adjusted for independent effects ofgender, age, residence-incinerator distance, education, working position, active and passive smoking, residence duration, occupational exposure, odor annoyance perception was significantly associated with the following respiratory symptoms/diseases: phlegm (OR 2.13, 95%CI 1.40-3.23), cough (OR 2.54, 95%CI 1.74-3.71), Chronic Obstructive Pulmonary Disease (OR 1.88, 95%CI 1.01-3.48), dyspnea (OR 1.89, 95%CI 1.33-2.67), asthma (OR 1.95, 95%CI 1.14-3.35), asthma symptoms (OR 1.85, 95%CI 1.23-2.78) and allergic rhinitis (OR 1.53, 95%CI 1.05-2.24). Conclusion: Our study shows an association among respiratory effects and odor annoyance perception, which thus might be used as a proxy of environmental air pollution exposure.

Background : reduction of risk factor exposure in Chronic Obstructive Pulmonary Disease (COPD) patients can reduce the disease worsening. Aim : to evaluate the risk factors associated with 12 month worsening of COPD in patients of Italian general practitioners (GPs). Methods : prospective observational study in different Italian areas. 139 GPs enrolled 1874 patients with COPD diagnosis. Questionnaires were used to collect data on COPD management, health status and risk factors at baseline and after 12 months. COPD worsening was defined as a 1+ level shift in the severity categories. Univariate analyses were run to assess the relationship between gender, age, risk factor exposure, GPs9 disease management and 12 month COPD worsening. Multiple logistic regression analysis was run to evaluate the risk factors associated with COPD worsening, adjusting for potential confounders. Results : 784 patients had complete information to assess the variations in COPD severity according to the 2011 GOLD guidelines. After 12 months, 15.6% of patients had a worsening of the severity level. Univariate analyses showed a significantly higher frequency of worsening in smokers, as well as in patients without a specialist/GP supervision, not using pneumococcal/influenza vaccinations and without an appropriate drug prescription. The logistic regression analysis highlighted significant associations between severity worsening and older age (>74 yrs) (OR 1.92), active smoke (OR 2.10) and unappropriate COPD treatment (OR 3.26). Conclusions : in order to try to stop COPD worsening it is important to help patients quitting smoking and to prescribe appropriate medicines. Funded by the Italian Health Ministry.

ETS exposure is associated with an increased risk of respiratory/allergic disorders. Aim : to assess the associations between lifetime ETS exposure and current respiratory health. Methods : Through a questionnaire, we collected information on lifetime ETS exposure at workplace, home, other places, in 1977 never smoker women living in four Italian areas (mean age 45.9). A cumulative ETS exposure index (ETSi) was computed basing on duration, frequency and the subjectively evaluated level of exposure during different life periods. The lifetime exposure was defined as light, moderate, and heavy according to the tertiles of the ETSi distribution. Results : Multivariate analyses showed a strength dose-response association of the lifetime ETS exposure level with all considered respiratory/allergic disorders. View this table: Table 1. Odds ratios (95% confidence intervals) for the association between ETS lifetime exposure and respiratory health (ref. never exposure). Conclusion: These information indicate the need to spread the smoking ban in public places and to suggest the abatement of ETS in private setting. Data collected before the Italian regulation on smoking ban in public places (January 2005).

Aim: to quantify the distribution of overlapping diagnosis of Asthma (A), Chronic Bronchitis (CB) and Emphysema (E), stratifying by blood eosinophilia (EOS+/EOS-). To evaluate the role of environmental/host risk factors for eosinophilic phenotypes of A and COPD (CB+E). Methods: 1919 subjects (8-88 yrs, 49% males) enrolled in an Italian cross-sectional study (1991-93), filled in a questionnaire on respiratory symptoms/diseases and risk factors and underwent a blood test. Eosinophil count is expressed as % of total leucocytes (EOS+ >3%). A double proportional Venn diagram is used to show the distribution of A, CB, E and their overlapping categories. A Multinomial Logistic Regression were run to assess the association of A or COPD eosinophilic phenotypes with gender, age, smoke, work exposure, eczema, rhinitis and diagnosis of asthma or COPD (Odd Ratio–OR, Confidence Interval–CI 95%). Results: AsmaEOS+ and AsmaEOS- are associated with COPD (OR 5.1 vs 6.9) and rhinitis (6.3 vs 2.4); AsmaEOS+ is also associated with age Conclusions: eosinophilic pattern is more frequent in young people and generally EOS+ subjects tend to be non smokers. The results confirm the expected overlap among respiratory diagnosis and show higher values in EOS- condition.

Background:Guideline recommendations for COPD management are only partially applied within primary care clinical practice.Objective:To compare the COPD management by Italian general practitioners (GPs) according to either the old GOLD (oGOLD) or the new GOLD (nGOLD) guidelines.Research design and methods:Observational study in different Italian areas. A total of 176 GPs enrolled their patients with a COPD diagnosis. Questionnaires were used to collect data on: COPD symptoms, disease severity, exacerbations, prescribed pharmacological and non-pharmacological treatments. COPD severity was estimated according to oGOLD and nGOLD guidelines.Results:A total of 526 subjects had complete information to assess COPD severity level according to guidelines (symptoms level, spirometry, history of exacerbations). The investigated subjects were more frequently males (71.2%) with a mean age of 72.5 years, and ex-smokers (44.4%). GPs reported sufficient control of the disease in 47.2% of the subjects with over two exacerbations in the last 12 months. Most patients have moderate COPD (51.5%), according to oGOLD, and belong to D groups (high risk, more symptoms) (45.6%), according to nGOLD. Overall, a low use of post-bronchodilator spirometry (65.1%) and of pulmonary rehabilitation (13.4%) was shown. The results highlighted a low prescriptive appropriateness but with higher value according to nGOLD than oGOLD: 61.4% vs 35.6%.Study limitations:Prescription data only provide limited information to judge prescribing quality, thus the results have to be evaluated with caution; moreover, this study was not designed to assess the difference between oGOLD and nGOLD.Conclusions:Guideline recommendations are applied only partially within clinical practice. A higher prescriptive appropriateness is shown by GPs using nGOLD classification. This might be due to the fact that nGOLD, with respect to oGOLD, takes into account anamnestic usual features considered by GPs in their clinical practice.

Background : Chronic obstructive pulmonary disease (COPD) represents an important and increasing burden worldwide and can be an important cause of premature death. Aims : to evaluate the risk factors for a death event reported by general practitioners (GPs) in their COPD patients. Methods : prospective observational study in different Italian areas. 139 GPs enrolled 1874 patients with COPD diagnosis. Questionnaires were used to collect data on COPD management, health status and risk factors at baseline and after 12 months. Univariate analyses were used to assess the relationship between reported death events and demographic characteristics (age, sex), risk factors exposure, health services use and GPs education. Logistic regression analysis was used to confirm the relationships found through the univariate analyses. Results : After 12 months 7.3% of patients died. Univariate analyses showed a significantly higher frequency of death in males, older age, subjects with a higher number of exacerbations, ex-smokers, subjects with higher use of health services (GPs visits, emergency room and hospital admissions) and higher COPD severity level; a lower frequency was shown in subjects that received a GPs education on smoking reduction. The logistic regression analysis confirmed the associations between death and older age (OR 1.10), higher number of exacerbations (OR 1.12), male gender (OR 1.83), current smoking (OR 2.08), hospital admissions (OR 2.10) and very severe COPD (OR 3.63). Conclusions : beside the known demographic characteristics, a very severe COPD requiring hospitalisation and current smoking habits are closely related to a reduced life expectancy. Funded by the Italian Health Minister.

Background: Several studies have found associations between exposure to heavy traffic pollution and respiratory diseases. The Geographical Information System (GIS) technology applied to epidemiological studies allows to integrate and analyze data coming from different sources with a spatial characterization. Aim: to assess the relation between the respiratory health status and exposure to heavy traffic pollution, using GIS technology. Methods: a sample of subjects living in Pisa was selected within the European IMCA2 project (Indicators for Monitoring COPD and Asthma in the EU). A questionnaire on socio-demographic characteristics, respiratory symptoms/diseases and risk factors was used. 540 people were classified, using GIS, on the basis of the distance of their house from main road: <150 metres, exposed subjects; >150 metres, controls. In addition, based on the daily heavy traffic annual average (DHTAA) data, the exposed subjects were classified as: highly exposed (DHTAA+), if living near roads with DHTAA ≥ 33; moderately exposed (DHTAA-), if living near roads with DHTAA < 33. Results: living close to roads with heavy traffic with respect to living far from roads with heavy traffic (>150 m) was associated with COPD symptoms/diagnosis. In particular, DHTAA+ had a significant higher risk of: usual phlegm (OR 1.85), usual cough (OR 2.18), COPD symptoms/diagnosis (OR 1.96); DHTAA- had a significant higher risk of: usual cough (OR 1.87), COPD symptoms/diagnosis (OR 1.87). Conclusions: heavy traffic individual exposure, objectively evaluated through GIS technology, is associated with COPD symptoms/diagnosis.

Background: Chronic Obstructive Pulmonary Disease (COPD) is a common disease with an increasing burden, often underdiagnosed in general practice (GP), especially among high risk groups. Aim: to investigate the prevalence and burden of different COPD related groups in an Italian general population sample. Methods: 1620 subjects living in Pisa (Central Italy) participated in a cross-sectional study (2009-11) within the IMCA2 (Indicators for Monitoring COPD and Asthma in the EU) project. An interviewer administered questionnaire on socio-demographic characteristics, respiratory symptoms/diseases, cardiovascular diseases (CVD), risk factors and health services use was used. 689 (mean age: 53.6yrs±16.7; 47.3% males) subjects carried out also a spirometry test (GOLD airway obstruction (AO): FEV1/FVC <0.7). Following features of COPD were considered: 1. COPD: diagnosis +/- chronic respiratory symptoms (CRS)/AO, 2. CRS, 3. AO+/-CRS, 4. No COPD/CRS/AO. Results: 10.3% of subjects had COPD, 5.7% CRS, 18.3% AO+/-CRS. By multinomial analysis, COPD resulted significantly associated to age > 59 yrs (OR 5.49), former smoker (OR 3.50), current smoker (OR 2.29), occupational exposure (OR 2.32), GP (OR 3.84) and specialist (OR 2.31) visits and laboratory test (OR 4.68) for respiratory problems; CRS to GP visits (OR 4.24), emergency room visits (OR 2.36); AO+/-CRS to age > 59 yrs (OR 5.22), current smoker (OR 1.88), specialist visits (OR 2.16). Conclusions: COPD related risk profiles and a significant use of health services in subjects without diagnosis suggest a probable underdiagnosis of COPD in an Italian general population sample. Thus it is advisable to increase GP and patients awareness in detecting the disease in its earliest states.

Rationale: to identify predictors of risk of having Sleep Apnea Syndrome (SAS) in an Italian general population sample surveyed 18 years apart. Methods: we studied a general population sample enrolled in a cross-sectional study carried out in Central Italy (Pisa) in 1991-1993 (PI1). Part of the same sample was enrolled in a later cross-sectional study within the framework of the European Union funded project IMCA2 (Indicators for Monitoring COPD and Asthma in the EU) in 2009-2010 (PI2). In both studies, the subjects filled in a standardized questionnaire about health status and risk factors and performed spirometry. The risk of having SAS was scored using the standardized Berlin Questionnaire on the longitudinal subsample selected for the analysis. A Logistic Regression Model (LRM) was run to assess the association among high risk of having SAS at PI2 and baseline risk factors: age, sex, Body Mass Index (BMI), smoking habits, hypertension and diagnoses of asthma, COPD, rhinitis. Results: the sample (n=1145; ranges of initial (8-78 years) and final age (25-96 years); males 45.9%) showed a 25.7% prevalence of SAS high risk at PI2. By the LRM, high risk of having SAS resulted significantly associated with baseline characteristics: age 25-64 (Odd Ratio–OR 3.52), age ≥ 65 (OR 4.46), BMI 25-29 (OR 2.48), BMI ≥ 30 (OR 5.06), ex-smoker (OR 1.45), hypertension (OR 2.07), diagnoses of rhinitis (OR 1.52) and COPD (OR 2.09). Conclusions: previous history of smoking habits and diagnoses of COPD and rhinitis, as well as hypertension, increasing age and BMI are predictors of high risk of having SAS at a 18 years follow-up.