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Background: Pulmonary microvascular occlusions can aggravate SARS-CoV-2 pneumonia and result in a variable decrease in capillary blood volume (Vc). Dyspnoea may persist for several weeks after hospital discharge in many patients who have "radiologically recovered" from COVID-19 pneumonia. Dyspnoea is frequently "unexplained" in these cases because abnormalities in lung vasculature are understudied. Furthermore, even when they are identified, therapeutic options are still lacking in clinical practice, with nitric oxide (NO) supplementation being used only for severe respiratory failure in the hospital setting. Nebivolol is the only selective β1 adrenoceptor antagonist capable of inducing nitric oxide-mediated vasodilation by stimulating endothelial NO synthase via β3 agonism. The purpose of this study was to compare the effect of nebivolol versus placebo in patients who had low Vc and complained of dyspnoea for several weeks after COVID-19 pneumonia. Methods: Patients of both genders, aged ≥18 years, non-smokers, who had a CT scan that revealed no COVID-related parenchymal lesions but still complained of dyspnoea 12-16 weeks after hospital discharge, were recruited. Spirometrical volumes, blood haemoglobin, SpO2, simultaneous diffusing capacity for carbon monoxide (CO) and NO (DLCO and DLNO, respectively), DLNO/DLCO ratio, Vc and exhaled NO (eNO) were measured together with their dyspnoea score (DS), heart frequency (HF), and blood arterial pressure (BAP). Data were collected before and one week after both phosphorus (P) and nitrogen (N) (2.5 mg od) double-blind cross-over administered at a two-week interval. Data were statistically compared, and p

Background: Chronic obstructive pulmonary disease (COPD) is a complex, progressive respiratory condition characterized by heterogeneous clinical presentations (phenotypes). The aim of this study was to assess the prevalence of the main COPD phenotypes and match each phenotype to the most fitting clinical and lung function profile.Methods: The CLIMA (Clinical Phenotypes in Actual Clinical Practice) study was an observational, cross-sectional investigation involving twenty-four sites evenly distributed throughout Italy. Patients were tentatively grouped based on their history and claimed prevailing symptoms at recruitment: chronic cough (CB, suggesting chronic bronchitis); dyspnoea (possible emphysema components, E); recurrent wheezing (presuming asthma components, A). Variables collected were: anagraphics; smoking habit; history of asthma; claim of >1 exacerbations in the previous year; blood eosinophil count; total blood IgE and alpha1 anti-trypsin (α1-AT) levels; complete lung function, and the chest X-ray report. mMRC, CAT, BCS, EQ5d-5L were also used. The association between variables and phenotypes were checked by Chi-square test and multinomial logistic regression.Results: The CB phenotype was prevalent (48.3%), followed by the E and the A phenotypes (38.8% and 12.8%, respectively). When dyspnea was the prevailing symptom, the probability of belonging to the COPD-E phenotype was 3.40 times higher. Recurrent wheezing was mostly related to the COPD-A phenotype. Lung function proved more preserved in the COPD-CB phenotype. Smoke; n. exacerbations/year; VR, and BODE index were positively correlated with the COPD-E phenotype, while SpO2, FEV1/FVC, FEV1/VC, and FEV1 reversibility were negatively correlated. Lower DLco values were highly probative for the COPD-E phenotype (p

Background: The choice of the Dry Powder Inhaler (DPI) to prescribe is a critical issue. The estimation of DPIs usability depends on the objective assessment of several indices related to both subjective and objective determinants. The Global Usability Score (GUS) Questionnaire is a comprehensive tool usable for checking, comparing, and ranking inhalers’ usability objectively in real life, but it takes some time to fill.Aim: The aim of this study was to favour the quicker check of DPIs usability in clinical practice by means of a simplified short-form GUS (S-GUS) Questionnaire, while maintaining the high specificity and sensitivity of the original, extended version of the Questionnaire (O-GUS questionnaire).Methods: The usability of the six most prescribed DPIs was assessed in 222 patients with persistent airway obstruction and needing long-term inhalation treatments. LASSO regression and multicollinearity test were used to select the subset of questions of the O-GUS questionnaire, with the highest information power. Each item was then scored using the corresponding coefficient in the linear regression (normalized at 50 as the O-GUS score). Agreement between the original and the short-form questionnaire was evaluated using the Cohen’s kappa statistic (κ). The overall S-GUS values obtained for each DPI were then compared to those from the O-GUS, in the same patients, using a Bayesian indirect comparison (IC) model.Results: After the statistical selection of the items mostly contributing to the overall score, the novel S-GUS questionnaire consists of twelve items only. Nine items are related to patients’ opinion before DPIs handling, and three to the nurse’s assessment after DPIs practicality. O-GUS and S-GUS score were strongly correlated (R2=0.9843, p25; “pretty good” by values ≤25≥15, and “insufficient” by values

Introduction Inhalation devices affect both the effectiveness and the therapeutic outcomes in persistent airway obstruction, and the effects are largely independent of the drug(s) assumed. Usability is a complex and comprehensive indicator of inhalation devices’ performance. The Global Usability Score (GUS) Questionnaire is an investigational tool designed to assess objectively the patients’-related and unrelated domains of devices’ usability. Methods The GUS questionnaire was administered to all consecutive COPD patients referring for three months to the Lung Unit of CEMS Specialist Centre (Verona, Italy). The usability of seven Dry Powder Inhalers (DPIs) indicated as appropriate in COPD was tested and compared: Breezhaler, Diskus, Ellipta, Genuair, Nexthaler, Spiromax, and Turbohaler. Patients were divided in two groups, checked separately, according to their DPIs previous experience. A Bayesian Indirect Comparison (IC) model was built to assess “global usability” ranking. Results A total of 103 patients were investigated: 74 patients already instructed in DPI use and 29 naive to DPIs. IC analysis proved Ellipta as the device characterized by the highest usability, while Breezhaler the device with the lowest usability in both groups of COPD patients (both with probability > 90%). Moreover, Turbohaler ranked second according to the Bayesian pooling, followed by Diskus, Spiromax, Nexthaler, and Genuair in patients already instructed in DPI use, while the ranking order was not as much well defined in naïve patients, likely due to their too small sample. Conclusions Usability is a multifaceted indicator that contributes to assess the factual DPIs’ convenience in real life. DPIs are characterized by different levels of real-life usability, which can be checked, compared and ranked by means of the GUS score. Electronic supplementary material The online version of this article (10.1186/s40248-019-0192-5) contains supplementary material, which is available to authorized users.

Background Acute cough is the most common symptom among children in primary care, but the impact of cough episodes was never investigated in Italian families. Methods A cross-sectional telephone survey was conducted on a representative sample of Italian families, randomly selected from general population; a specific and validated questionnaire was used. Results The sample (604 calls) was uniform by geographical distribution, and by children age and gender. Mean cough episode was 3.1/year, they were short lasting (only 4.7% > 2 weeks). Independent predictors of children cough episodes were parents’ active smoking habit and work (p € 30 in 18.4% of cases). Conclusions Parents’ actions against cough episodes were variable, depending on their beliefs, smoking habit, and occupational status. The parents’ perceived efficacy of usual prescriptions is poor, and their willingness to pay out-of-pocket for an “effective remedy” against cough is high. The interest for alternative treatments is not negligible in these circumstances. Electronic supplementary material The online version of this article (10.1186/s40248-019-0180-9) contains supplementary material, which is available to authorized users.

Bronchial asthma is an inflammatory disease of the airways. Beclomethasone dipropionate/Formoterol (BDP/F) and Fluticasone furoate/Vilanterol (FF/V) are two of the most effective LABA/ICS combinations for managing persistent bronchial asthma. Aim of the study was to compare the outcomes achieved in mild-to-moderate asthma patients assuming BDP/F 100/6 μg b.i.d. (Group A) or FF/V 92/22 μg once-daily (Group B) for 12-months. No head-to-head long-term comparison is available at present.Data were automatically and anonymously obtained from the institutional database: FEVThe PS-matching process returned a cohort of 40 group A patients matched with 40 patients of group B, fully comparable for demographics, clinical characteristics, and comorbidities. The improvement in lung function was significant in both groups (Both the ICS/LABA combinations proved effective, even if characterized by different patterns of effectiveness either in terms of lung function and of long-term clinical outcomes. Only the once-daily inhalation of combined FF/V 92/22 μg once-daily optimized systematically the exacerbation and hospitalization rates in mild-to-moderate asthma, together with all other outcomes over time. The effectiveness of FF/V 92/22 once-daily μg proved progressive and time-dependent over the twelve-month period of the study, and associated to a higher adherence to treatment.

Background: Inhalation is the preferred route for respiratory drug delivery, but several factors contribute to the variability of the respirable dose fraction. Instant velocity and the dynamic characteristics of the droplet cloud represent crucial factors. Aim was to measure and compare the instant velocity and the consistency of emitted cloud from five different MDIs (A - Salbutamol sulphate 100mcg, GSK; B - Salbutamol sulphate 100mcg, Valeas; C - Salmeterol xinafoate/Fluticasone propionate 25/125mcg, GSK; D - Formoterol fumarate/Bechlomethasone propionate 6/100mcg, Chiesi; E - Formoterol fumarate/Fluticasone dipropionate 5/125mcg, Mundipharma) and one SMI (Tiotropium bromide 5mcg, Boehringer Ingelheim), at different distance from the nozzle and canister filling. Methods: Measurements were made at 90, 50, and 10% of canister filling, and at 5, 10, and 20 cm from the nozzle, for a total of 972 puffs. A high speed video photography protocol was adopted and high speed cameras (1.200 frames/ sec.) were used. Data were acquired by means of specialized softwares. Temperature, humidity, and vibrations occurrence were strictly controlled during measurements. Statistics: Anova and p < 0.05 were accepted as the minimum significance level. Results: MDIs generated different Instant velocities: MDI B generated the highest, while MDI A the lowest. As expected, velocity decreased in proportion to the distance from the nozzle. Except with MDI C, instant velocity decreased significantly over the first 50% of canister emptying, but dropped by >33% at 90% of emptying with all other MDIs (p < 0–037; p < 0.001; p < 0.005, and p < 0.001, respectively). Instant velocity was extremely lower (p < 0.001) and constant for all levels of canister filling (p = ns) with SMI. All MDIs had a very fast jet phase, ranging 0.01–0.03 s at 10 cm, and 0.03–0.05 s at 20 cm from the nozzle, without any significant difference from each other (p= ns). MDIs generated a cloud similarly tight (p = ns) at 10 and 20 cm from the nozzle, while it was extremely wider and constant with the SMI (p = 0–001). Also the cloud turbulence was minimized during the SMI emission. Discussion and Conclusions: MDIs are characterized by a substantial variability in both their instant velocity and consistency of the emitted cloud at different levels of canister filling. SMI generates a much slower soft mist cloud which is constantly homogeneous and independent of canister emptying. These peculiarities assessed at bench are suggesting a higher dose consistency and a much more effective therapeutic performance also in real life.

Background: Asthma is a common disease of the airways with a significant burden for the society and for patients’ quality of life. The Social Impact of Respiratory Integrated Outcomes (SIRIO) study estimated a mean cost of 1,177.40 € per patient/year in Italy, in 2007. The aim of the present study was to update the cost of persistent asthma patients in Italy. Methods: An observational, retrospective, bottom-up analysis was carried out starting from the data base operating in the Lung Unit of the Specialist Medical Centre (CEMS), Verona (Italy), over the period June 2013-December 2015. Patients’ data were recorded over the 12 ± 2 months before the enrollment and during 12 ± 2 months of follow-up. The prospective was the Italian National Health Service and the broad Italian society. Clinical data were measured in terms of forced expiratory volume in 1 s (FEV1%) and number of relapses. Healthcare resources (namely; number of hospitalizations and/or ER admissions; number of visits; drug use and duration, and indirect costs) were recorded. Results: The cohort consisted of 817 patients with persistent asthma of different severity. They had a 42.96% male prevalence; a mean (±SE) age of 49.06 (±0.64) years; a mean 87.47% (±0.81) FEV1% pred. in baseline, and 69.16% of subjects had comorbidities. The mean (±SE) number of relapses was 0.91 (±0.09) per patient/year before the enrolment. After 12 months, FEV1% significantly improved by +6.31% (±0.45) from the corresponding baseline value (p < 0.001). The number of relapses decreased of −0.46 (±0.09) (p < 0.001). The estimated total annual cost per asthmatic patient was 1,183.14 € (±65.79 €) during the 12 months before the enrolment, and 1,290.89 € (±68.74 €) throughout the follow-up. The increase was mostly due to the significantly increased duration of therapeutic strategies. The costs of hospitalization, general practitioner and rescue medications were significantly decreased. Conclusions: The periodic update of cost analysis is a key to monitor the trend of main asthma outcomes and related expenditure over time. It allows to plan the most convenient actions in terms of prevention strategies and effective interventions, with the aim of optimizing the healthcare resources consumption and maximizing the impact on clinical outcomes and patients’ quality of life. The role of an appropriate pharmacological strategy still proves crucial in minimizing asthma morbidity and the corresponding socio-economic impact.

Background Cough is one of the most common discomforts affecting general population, which can disrupt subjects’ quality of life due to its physical, social, and psychological effects. Aim of the study was to investigate the impact of cough and related beliefs of general population. Methods A cross-sectional telephone survey was carried out by means of a specific, validated questionnaire on a representative sample of Italian general population. All the interviews were carried out according to the Computer Assisted Telephone Interview (CATI) methodology by expert, professional interviewers. Distributions of all answers were calculated in the overall sample. Results A total of 1,251 subjects (mean age: 49 years; females 44.2 %) completed the interviews. The overall number of telephone calls was 5362, and the corresponding redemption rate was 1/4.3 (23.%). The sample was representative of national population in terms of geographical distribution, age, gender, and smoking habit. The majority of respondents was convinced that cough is merely a symptom of several different diseases, but 46.4 % of respondents affirmed that cough should be regarded as “a disease” per se. Only 29.1 % of subjects say that they usually do not complain of any cough over the year, while 18.4 % reported ≥ 3 episodes of cough/year. These episodes have a duration ranging 10–30 days in 19.9 % of subjects, and > 30 days in 6.9 % of subjects. The majority of respondents is worried about their cough only after 1 week, but 76.9 % of subjects is much more worried if cough affects a child. After a few days of cough, 23.1 % of subjects use domestic remedies; 20.9 % ask their pharmacist, and 33.4 % their doctor, being GPs (69.6 %) and lung physicians (16.2 %) the most asked professionals. The occurrence of bronchitis, pneumonia, upper airway infections, and allergic troubles are the most feared events. The majority of respondents are convinced that antibiotics and steroids should not be regarded as the gold standard for treating persistent cough (61.2 and 58.2 %, respectively), while anti-tussive drugs and aerosols in general are regarded as the most effective strategies (69.1 and 74.1 %, respectively). Moreover, 33.8 % of the sample is in favour of homeopathic drugs, while 23.2 % had already used an homeopathic anti-tussive syrup, and 27.6 % of subjects are really interested in using the homeopathic approach. The willingness to pay for an effective anti-tussive remedy was: 46.3 % up to 10 €; 27.8 % up to 20 €, and 13.3 % more than 20 €. Conclusions Cough confirms its high impact in Italy, and a substantial proportion of individuals regards cough as “a disease”. Only one out of three Italians refers to their doctor, but when cough is already persistent. Cough in children is much more feared than in adults. The majority of Italians have a proper and conservative position versus both antibiotic and the systemic steroid uses against cough. The Italian attitude to aerosol therapy confirms very high. Differently from the cough guidelines, anti-tussive drugs are highly valued among Italian people. The attitude and the interest to homeopathic anti-tussive remedies proves high. Finally, the willingness to pay for an effective anti-tussive remedy is quite high in Italy. Electronic supplementary material The online version of this article (doi:10.1186/s40248-016-0072-1) contains supplementary material, which is available to authorized users.

Background: Several comorbidities frequently affect COPD progression. Aim of the study was to assess the prevalence of main comorbidities by gender and disease severity in a cohort of COPD patients referring for the first time to a specialist institution. Methods: The study was a non-interventional, cross-sectional investigation carried out via automatic and anonymous selection from the institutional data base over the period 2012–2015. Inclusion criteria were: subjects of both sex aged ≥40 years; diagnosis of COPD according to GOLD guidelines 2014; the availability of a complete clinical record file. Variables collected were: lung function; smoking history; BMI; the Charlson Comorbidity Index (CCI); number and kind of comorbidities for each patient. Results: At least one comorbidity of clinical relevance was found in 78.6 % of patients, but at least two in 68.8 %, and three or more were found in 47.9 % of subjects. Mean CCI was 3.4 ± 1.6sd. The overall prevalence was 2.6 comorbidities per patient, but 2.5 in males, and 3.0 in females, respectively (p < 0.05). Cardio-vascular disorders were the most frequent, but significantly more frequent in males (44.7 vs 30.7 %, respectively), while the metabolic, the digestive and the osteo-articular disorders were prevailing in females (12.4 vs 9.2; 14.2 vs 4.8, and 6.0 vs 3.8, respectively). In particular, chronic cor pumonale and arrhythmias mainly prevailed in men and congestive heart failure in females, while arterial hypertension resulted equally distributed. As concerning respiratory disorders, pneumonia, pleural effusions and chronic respiratory failure were more frequently found in men, while bronchiectasis and asthma-COPD overlap syndrome (ACOS) in females. Anaemia, gall bladder stones, osteoporosis and spontaneous fractures mostly prevailed in females, while gastric disorders of inflammatory origin and arthrosis were more frequent in males. Cognition disorders, dementia and signs of degenerative brain disorders were more frequently found in men, while depression in females. Finally, lung cancer was at the first place in men, but at the second in females. Conclusions: All comorbidities increased their prevalence progressively up to the last stage of COPD severity, except the cardio-vascular and the metabolic ones which dropped in the IV GOLD stage, presumably due to the high mortality rate in this severe COPD stage. The gender-dependency of comorbidities was confirmed in general terms, even if lung cancer proved a dramatic increase almost independently of sex.

Background: Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory condition which can lead to comorbidities of variable severity, cognitive dysfunction included. The role of supplemental oxygen in preventing COPD-induced cognitive deterioration is still debated, but only episodically investigated. The aim of this study was to compare the cognitive pattern of hypoxemic COPD subjects treated with long-term oxygen (LTOT) to that of patients of comparable severity assuming oxygen on irregular basis, and to normal reference values. Methods: Lung function, arterial blood gases, health status, and cognitive function measured by means of four psychometric tests focusing different domains of cognition (such as: MMSE, Clock test; TMT-A; TMT-B) were assessed in 146 well matched hypoxemic COPD patients (males n = 96, 66%; mean age = 70.5 ± 12.9). Seventy-three patients were assuming long-term oxygen (LTOT), while the remaining seventy-three were only using oxygen as needed (AN). Regarding statistics, t test and ANOVA (Duncan test) were used to analyze data, assuming a p < 0.05 as the lowest limit of significance. Results: Even though all COPD patients showed a poorer psychometric profile vs corresponding normal reference values, LTOT patients showed a lower prevalence of severe deterioration in cognition. Also the extent of impairment was significantly lower in these patients when assessed by TMT-A and TMT-B (p < 0.012 and 0.001, respectively), but not when measured by MMSE and Clock test (both p = ns). Several domains of cognition are variably affected by persistent hypoxemia in COPD patients. A panel of psychometric tools is needed for identifying the pattern of cognitive dysfunctions in these patients. Memory and attention (functions assessed by MMSE and Clock test) are only mildly-moderately affected, while visual processing, reproduction of numeric sequences, cognition flexibility, and shifting capacity (functions assessed by TMT-A and TMT-B) are much more deteriorated (p < 0.012 and p < 0.001, respectively). Conclusions: Only LTOT allows to preserve significantly (p < 0.022) cognitive functions from the COPD-induced deterioration. This assumption is of strategic value for COPD patients who are prescribed long-term oxygen because they frequently are not aware of the cognitive risks related to their condition.

Background: Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality at global level even if still underestimated. The insufficient use of specific tools for an objective definition and staging, the inadequate awareness of COPD, but also a difficult patient-to-doctor communication, can contribute to the poor management of COPD. A very simple, short and sensitive questionnaire (the “COPD Assessment Test” - CAT questionnaire) is now available for assessing the impact of COPD on the patient’s health. The present study was designed to provide such evidence using data generated throughout Italy. Methods: The Italian validated version of the CAT questionnaire was distributed to 681 consecutive COPD patients of different severity (males = 480), well matched for age, gender, smoking habit, geographical distribution, BMI, dyspnoea score and educational level. The CAT score variability was investigated vs all anagraphic, and clinical variables, and spirometric indices of lung function (regression). No Italian data are available to our knowledge on the CAT use, neither in General Medicine, nor in the specialist setting. Results: Data of this study confirmed that the CAT questionnaire is a sensitive, simple, and quick tool for assessing the respiratory status of COPD patients. The CAT score proved not conditioned by the patient’s age, gender, body size, geographical origin, and educational level. It was inversely correlated with the spirometric values, even if not uniquely linked to them. Conclusions: The CAT score does not represent a surrogate measurement of lung function: it is an instrument which focuses on different areas of respiratory health in COPD patients, thus providing an useful and objective tool for the long-term clinical and therapeutic monitoring of COPD patients in the specialist outpatient setting.

Background: Information on the effects of long-term oxygen treatment (LTOT) on blood hemoglobin (Hb) in severe COPD are limited. The aim was to assess blood Hb values in severe COPD, and investigate the time-course of both Hb and blood gas changes during a 3-year telemetric LTOT. Methods: A cohort of 132 severe COPD patients (94 males; 71.4 years ± 8.8 sd), newly admitted to the tele-LTOT program, was investigated. Subjects were divided according to their original blood Hb: group A: 15 g/dl (ANOVA p

Background Information on the effects of long-term oxygen treatment (LTOT) on blood hemoglobin (Hb) in severe COPD are limited. The aim was to assess blood Hb values in severe COPD, and investigate the time-course of both Hb and blood gas changes during a 3-year telemetric LTOT. Methods A cohort of 132 severe COPD patients (94 males; 71.4 years ± 8.8 sd), newly admitted to the tele-LTOT program, was investigated. Subjects were divided according to their original blood Hb: group A: 2 and PaCO2 (mmHg), SaO2 (%), and BMI were measured at LTOT admission (t0), and at least quarterly over three years (t1-t3). Wilcoxon test was used to compare t0 vs. t1 values; linear regression to assess a possible Hb-BMI relationship; ANOVA to compare changes in Hb time-courses over the 3 years. Results LTOT induced a systematic increase of PaO2, and changes were significant since the first year (from 52.1 mmHg ± 6.6sd to 65.1 mmHg ± 8.7 sd, p 2 were quite similar. Comparable and equally significant trends were seen in all subgroups (p 2 dropped within the first year of LTOT (from 49.4 mmHg ± 9.1sd to 45.9 mmHg ±7.5 sd, p 0-t1 comparison proved significant (p 2 decline over the remaining two years (p 15 g/dl (ANOVA p 2, PaCO2 and SaO2 dramatically improved. In anemic subjects effects were smaller and slower, oxygenation being equally ameliorated by LTOT. Conclusions LTOT effects on Hb and PaCO2 are regulated by an Hb-dependent gradient which seems independent of the original impairment of blood gases and of effects on oxygenation.