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STUDY OBJECTIVES: There are few studies evaluating (1) exercise capacity as assessed by the 6-minute walking distance (6MWD) test in large populations with obstructive sleep apnea (OSA); and (2) correlations with patients’ comorbidities. METHODS: This study presents a cluster analysis performed on the data of 1,228 patients. Severity of exercise limitation was defined on the basis of 6MWD. RESULTS: Sixty-one percent showed exercise limitation (29.2% and 31.9% mild and severe exercise limitation, respectively). About 60% and 40% of patients were included in cluster 1 (CL1) and 2 (CL2), respectively. CL1 included younger patients with high prevalence of apneas, desaturations, and hypertension with better exercise tolerance. CL2 included older patients, all with chronic obstructive pulmonary disease (COPD), high prevalence of chronic respiratory failure (CRF), fewer apneas but severe mean desaturation, daytime hypoxemia, more severe exercise limitation, and exercise-induced desaturations. Only CRF and COPD significantly (P < .001) correlated with 6MWD < 85% of predicted value. 6MWD correlated positively with apnea-hypopnea index, oxygen desaturation index, nocturnal pulse oxygen saturation (SpO(2)), resting arterial oxygen tension, mean SpO(2) on exercise, and negatively with age, body mass index, time spent during night with SpO(2) < 90%, mean nocturnal desaturation, arterial carbon dioxide tension, and number of comorbidities. Patients without severe comorbidities had higher exercise capacity than those with severe comorbidities, (P < .001). Exercise limitation was significantly worse in OSA severity class I when compared to other classes (P < .001). CONCLUSIONS: A large number of patients with OSA experience exercise limitation. Older age, comorbidities such as COPD and CRF, OSA severity class I, severe mean nocturnal desaturation, and daytime hypoxemia are associated with worse exercise tolerance. CITATION: Vitacca M, Paneroni M, Braghiroli A, et al. Exercise capacity and comorbidities in patients with obstructive sleep apnea. J Clin Sleep Med. 2020;16(4):531–538.

Background In hospitalized patients with coronavirus disease 2019 (COVID-19) pneumonia, progression to acute respiratory failure requiring invasive mechanical ventilation (MV) is associated with significant morbidity and mortality. Severe dysregulated systemic inflammation is the putative mechanism. We hypothesize that early prolonged methylprednisolone (MP) treatment could accelerate disease resolution, decreasing the need for intensive care unit (ICU) admission and mortality. Methods We conducted a multicenter observational study to explore the association between exposure to prolonged, low-dose MP treatment and need for ICU referral, intubation, or death within 28 days (composite primary end point) in patients with severe COVID-19 pneumonia admitted to Italian respiratory high-dependency units. Secondary outcomes were invasive MV-free days and changes in C-reactive protein (CRP) levels. Results Findings are reported as MP (n = 83) vs control (n = 90). The composite primary end point was met by 19 vs 40 (adjusted hazard ratio [aHR], 0.41; 95% CI, 0.24–0.72). Transfer to ICU and invasive MV were necessary in 15 vs 27 (P = .07) and 14 vs 26 (P = .10), respectively. By day 28, the MP group had fewer deaths (6 vs 21; aHR, 0.29; 95% CI, 0.12–0.73) and more days off invasive MV (24.0 ± 9.0 vs 17.5 ± 12.8; P = .001). Study treatment was associated with rapid improvement in PaO2:FiO2 and CRP levels. The complication rate was similar for the 2 groups (P = .84). Conclusion In patients with severe COVID-19 pneumonia, early administration of prolonged MP treatment was associated with a significantly lower hazard of death (71%) and decreased ventilator dependence. Treatment was safe and did not impact viral clearance. A large randomized controlled trial (RECOVERY trial) has been performed that validates these findings. Clinical trial registration. ClinicalTrials.gov NCT04323592., This multicenter observational study gave the first evidence that prolonged, low-dose methylprednisolone treatment is associated with a significantly lower hazard of death, reduced ICU burden and decreased ventilator dependence without affecting viral clearance in patients with severe COVID-19 pneumonia/ARDS.

BACKGROUND International Classification Functioning (ICF) Core Sets represent a holistic approach to functioning within rehabilitation field. Information-reporting efficacy of a rehabilitation-based Respiratory ICF set applied on a large scale throughout the ICS Maugeri network was tested. METHODS A prospective multi-center study (May-November 2018) was conducted for all respiratory inpatients consecutively admitted for rehabilitation. Doctors, physiotherapists, psychologists, nurses used an electronic Respiratory ICF set (33 items among the ICF body functions, activity and participations components) at admission and at discharge to assess the disability changes. The ICF report qualifiers, from 0 (no impairment) to 4 (maximum impairment), guided clinical, diagnostic and rehabilitation prescriptions. RESULTS 1886 patients (69.6±10.8 years; M=1045) were admitted (589 chronic obstructive pulmonary disease, 494 chronic respiratory failure [CRF], 21 prolonged mechanical ventilation [PMV], 496 with other respiratory diseases), of whom 15 died, and 117 were transferred to acute care. The mean length of stay was 23.1±11.8 days (range 1-122). The mean time to fill in the ICF set was 23.16±0.70 min. The rate of filled charts improved from 16% in May to 100% in November. The baseline distribution of the more severe qualifiers (>2) progressively increased from the whole sample to the PMV subgroup. After rehabilitation, in the whole sample and in the CRF and PMV subgroups, the severity qualifiers significantly decreased (P

PAH is characterized by impaired pulmonary gas exchange, with worsening of ventilation/perfusion ratio and increase in physiological dead space. In our Institute, we developed a rehabilitation program for PAH patients with aerobic, resistive and breathing exercises, including CB sessions. CB resulted useful in conditions characterized by a gas exchange impairment as chronic obstructive pulmonary disease, heart failure and high altitude hypoxia, improving oxygenation and vagal activity and concomitantly reducing sympathoexcitation, with a favorable effect on symptoms and prognostic variables. Our purpose is to evaluate the possible effect of a CB session on the arterial blood gas analysis (ABGA) in PAH patients. Sixteen PAH patients (age 53±14.51;1 male) were enrolled. They were connected to a RESPeRATE device (InterCure Ltd, Lod, Israel) with headphones and a thoracic belt aimed at registering spontaneous respiratory activity. The software provides music with alternate high and low tones, for the progressive lowering of the respiratory rate up to a target of 6–7 breaths/min, with a duration of about 25–30 min for every daily session. An ABGA was performed pre and post CB session, with no changes in oxygen therapy, if present. ABGA data are presented in the table below. Only the difference in pO2 was statistically significant (p=0.05). This is the first study showing that CB daily session may represent a very easy, not expensive and well-tolerate method to improve oxygenation in patients with PAH.

Background: Adherence to inhaled drugs is linked to patients’ satisfaction with their device, and an incorrect use can negatively affect the outcomes of asthma treatment. We speculated that this is particularly true in elderly asthmatic subjects. Aim: We performed a national pre-post interventional multicentre study, enrolling moderate-to-severe asthmatic subjects aged ≥65 ​years treated with fixed inhaled combination drugs by dry powder inhaler (DPI) or pressurized metered dose inhaler (pMDI). Adherence and critical errors were evaluated by means of validated questionnaires at first visit (V1) and after 3–6 months (V2). At V1, subjects underwent intensive training on the correct use of their device by physical demonstration. Results: A total of 411 asthmatics (F/M: 238/173, mean age±SD: 72 ​± ​5 ​years) participated to the study. At V1, 50% of the study subjects showed an Asthma Control Test (ACT) score ≤19 despite GINA step 3 and 4 treatment, and 40% had experienced at least one severe asthma exacerbation in the previous year. Poor adherence to treatment was recorded in 43% of subjects, and at least one error in using the device was registered in 56% of subjects. At V2, available for 318 patients, both the percentage of individuals with poor adherence and with at least one critical error significantly decreased (from 46% to 25%, and from 49% to 25%, respectively; p ​

Objective Patients with obstructive sleep apnea (OSA) have an altered control of breathing during wakefulness. Thus far, whether and how treatment with continuous positive airway pressure (CPAP) may restore these abnormalities has been poorly understood. The aim of this study was to investigate the long-term effects of CPAP on the breathing pattern, ventilatory drive (VDr), and chemoreceptor sensitivity in OSA patients. Patients and methods This was a prospective, observational study, carried out in an academic sleep outpatient clinic. A total of 62 patients with OSA (mean age [SD], 51 [11] years) underwent polysomnography (PSG), breathing pattern assessment, mouth occlusion pressure, ventilatory response to hypoxemia (Ve/SaO2), and hypercapnia (Ve/PETCO2) before and after CPAP titration and during 12-month follow-up. A total of 48 age-matched healthy subjects served as controls. Patients with good (≥6 h/night) and poor ( Results At baseline, VDr as well as thoracic and inspiratory impedances were greater in patients with OSA compared with controls and were reduced by CPAP treatment, starting from the night of titration (P Conclusion In OSA patients, the mechanics of breathing are inefficient because of an imbalance of the VDr. Regular CPAP treatment improves the efficiency of the respiratory system and normalizes the hypoxemic stimulus.

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, p 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 The reviews of this paper are available via the supplemental material section.

Background: Lung diffusing capacity (DLCO) and lung volume distribution predict exercise performance and are altered in COPD patients. If pulmonary rehabilitation (PR) can modify DLCO parameters is unknown. Objectives: To investigate changes in DLCO and ventilation inhomogeneity following a PR program and their relation with functional outcomes in patients with COPD. Methods: This was a prospective, observational, multicentric study. Patients were evaluated before and after a standardized 3-week PR program. Functional assessment included body plethysmography, DLCO, transfer factor (KCO) and alveolar volume (VA), gas exchange, the 6-min walking test (6MWT) and exercise-related dyspnea. Patients were categorized according to the severity of airflow limitation and presence of ventilation inhomogeneity, identified by a VA/TLC Results: Two hundred and fifty patients completed the study. Baseline forced expiratory volume in 1 s (FEV1) % predicted (mean ± SD) was 50.5 ± 20.1 (76% males); 137 patients had a severe disease. General study population showed improvements in 6MWT (38 ± 55 m; p < 0.01), DLCO (0.12 ± 0.63 mmol × min-1 kPa-1; p < 0.01), lung function and dyspnea. Comparable improvements in DLCO were observed regardless of the severity of disease and the presence of ventilation inhomogeneity. While patients with VA/TLC LCO increasing their VA (177 ± 69 ml; p < 0.01), patients with VA/TLC >0.8 improved their KCO (8.1 ± 2.8%; p = 0.019). The latter had also better baseline lung function and higher improvements in 6MWT (14.6 ± 6.7 vs. 9.0 ± 1.8%; p = 0.015). Lower DLCO at baseline was associated with lower improvements in 6MWT, the greatest difference being between subjects with very severe and mild DLCO impairment (2.7 ± 7.4 vs. 14 ± 2%; p = 0.049). Conclusions: In COPD patients undergoing a PR program, different pathophysiological mechanisms may drive improvements in DLCO, while ventilation inhomogeneity may limit improvements in exercise tolerance.

Standard spyrometric assessment in chronic obstructive pulmonary disease (COPD) only evaluates bronchial obstruction. However, airflow limitation and hyperinflation are the main pathophysiological factors responsible for dyspnoea and reduced exercise tolerance in patients with COPD. This study evaluated the effects of aclidinium bromide 400 μg and glycopyrronium bromide 50 μg on these parameters. Patients with stable severe/very severe COPD were randomized in this double-blind, double-dummy, crossover, Phase IV study. Patients received single doses of each drug on separate days. Primary endpoints were changes in residual volume (RV) and intra-thoracic gas volume (ITGV), assessed by full-body plethysmography. Other endpoints included changes variations in lung ventilation inhomogeneity (Phase III slope of single-breath nitrogen washout test, SBN2), dyspnoea visual analogue scale, and pulmonary specific total airway resistances. Assessments were performed at baseline and 5, 15, 30, 60, and 180 min post-administration. Thirty-seven patients were randomized (31 male; mean age 71 years). Aclidinium and glycopyrronium significantly improved ITGV versus baseline at all-time points (p

BACKGROUND: Tracheostomy is one of the most common surgical procedures performed in critical care patient management; more specifically, ventilation through tracheal cannula allows removal of the endotracheal tube (ETT). Available literature about tracheostomy care and decannulation is mainly represented by expert opinions and no certain knowledge arises from it. METHODS: In lack of statistical requirements, a systematic and critical review of literature regarding tracheostomy tube removal was performed in order to assess predictor factors of successful decannulation and to propose a predictive score. We combined 3 terms and a literature search has been performed using the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE via Ovid SP; EMBASE via Ovid SP; EBSCO. Abstracts were independently reviewed: for those studies fitting the inclusion criteria on the basis of the title and abstract, full-text was achieved. We included studies published from January 1, 1995 until March 31, 2014; any sort of review and expert opinion has been excluded by our survey. English language restriction was applied. Ten studies have been considered eligible for inclusion in the review and were analysed further. RESULTS: Cough effectiveness and ability to tolerate tracheostomy tube capping are the most considered parameters in clinical practice; other parameters are taken into different consideration by many authors in order to proceed to decannulation. Among them, we distinguished between objective quantitative parameters and semi-quantitative parameters more dependent from clinician's opinion. We then built a score (the Quantitative semi Quantitative score: QsQ score) based on selected parameters coming from literature. CONCLUSIONS: On our knowledge, this review provides the first proposal of decannulation score system based on current literature that is hypothetical and requires to be validated in daily practice. The key point of our proposal is to give a higher value to the objective parameters coming from literature compared to less quantifiable clinical ones.

Study objective We conducted a retrospective study on patients with acute myocardial infarction (AMI) and evaluated the incidence and prevalence of Chlamydia pneumoniae infection. Methods Sixty-one consecutive patients with AMI aged younger than 65 years were enrolled. Within 24 h of hospital admission, serum samples and pharyngeal swab specimens were obtained from all patients. In 49 of 61 patients, after a mean of 28 days from hospital admission, a second serum sample was drawn. A third serum sample was obtained in 23 of 61 patients. Serologic testing for Chlamydia pneumoniae was performed by a microimmunofluorescence test. We applied a nested-polymerase chain reaction for C pneumoniae DNA detection to pharyngeal swab specimens. Simultaneously, we performed a serologic study for C pneumoniae infection on 61 serum samples obtained from blood donors, matched for age, sex, and smoking habits. Results Serologic test results for C pneumoniae were consistent with acute reinfection in 12 patients, with chronic infection in 23 patients, and results were negative in 26 patients with AMI. In 3 of 12 patients with acute reinfection pattern and in 3 of 23 patients with chronic infection pattern, C pneumoniae DNA was detected on pharyngeal swab specimens. A significantly higher prevalence of IgG titers was observed in patients with AMI (35/61) compared to blood donors (18/61) (p=0.003). Conclusions Our data confirm the possible role of C pneumoniae infection in coronary heart disease and suggest that reinfection may trigger the onset of AMI.

Between July 1992 and June 1993, 61 patients with severe community-acquired pneumonia were admitted to our semi-intensive care unit. For all patients chest X-ray, blood gas analysis while breathing room air, Gram stain and culture of bronchoaspirate, determination of acute and convalescent anti-body titers for Legionella pneumophila, Mycoplasma pneumoniae and Chlamydia pneumoniae, blood culture when body temperature was greater than 38 degrees C, and pharyngeal swab for C. pneumoniae detection by means of an indirect immunofluorescence test were obtained. Among the patients enrolled, 15 suffered from chronic obstructive pulmonary disease, 18 had serious chronic diseases, 9 were immunodeficient and 15 had cardiovascular diseases, and only 4 had no underlying disease. Etiologic diagnosis was reached in 30 cases (49%). As expected, due to the high rate of seriously ill patients, gram-negative pathogens were identified most commonly (15%), followed by Streptococcus pneumoniae (10%) and, surprisingly, by C. pneumoniae (10%). These data, showing the possible emergence of Pseudomonas aeruginosa and C. pneumoniae, warrant further studies in order to verify whether the epidemiological pattern of severe community-acquired pneumonia is actually changing.

Chronic Obstructive Pulmonary Disease (COPD) is a complex pathological condition associated with an important reduction in physical activity and psychological problems that contribute to the patient's disability and poor health-related quality of life. Pulmonary rehabilitation is aimed to eliminate or at least attenuate these difficulties, mainly by promoting muscular reconditioning. The scope of this paper has been the analysis of the literature on pulmonary rehabilitation in COPD patients has appeared in the last five years, focusing on the principal outcomes obtained. The results demonstrate that pulmonary rehabilitation has a beneficial effect on dyspnoea relief, improving muscle strength and endurance. Moreover, pulmonary rehabilitation appears to be a highly effective and safe treatment for reducing hospital admissions mortality and improving health-related quality of life in COPD patients. It represents, therefore, a very important therapeutic option that, along with standard pharmachological therapy, can be used to obtain the best patient management. The favourable results obtained with pulmonary rehabilitation programs should stimulate researchers to improve our understanding of the mechanisms that form the basis of the beneficial effects of this therapeutic intervention. This would in turn increase the effectiveness of pulmonary rehabilitation in COPD patients.

Respiratory infections precipitate wheezing in many asthmatic patients and may be involved in the aetiopathogenesis of asthma. Several studies have demonstrated that viral infections may provoke asthma. Bacterial infections seem to play a minor role. However, Chlamydia pneumoniae has been recently reported as a possible cause of asthma. The aim of the present study was to evaluate the role of C. pneumoniae infection in acute exacerbations of asthma in adults. Seventy four adult out-patients with a diagnosis of acute exacerbation of asthma were studied. Acute and convalescent (> or = 3 weeks) serological determination of antibodies to cytomegalovirus, respiratory syncytial virus, adenovirus, influenza A and B, parainfluenza 1 and 3, Mycoplasma pneumoniae and Legionella pneumophila were performed by means of immunofluorescence tests. C. pneumoniae specific antibodies were detected by two microimmunofluorescence tests using a specific antigen (TW-183) and a kit with three chlamydial antigens. Pharyngeal swab specimens were also obtained for C. pneumoniae identification. Samples for bacterial culture were obtained in patients with productive cough (15 out of 74 patients). Fifteen patients (20%) presented seroconversion to at least one of the studied pathogens. Seven were found to be infected by virus, six by C. pneumoniae alone, and one by M. pneumoniae. One more patient showed seroconversion to C. pneumoniae and cytomegalovirus.(ABSTRACT TRUNCATED AT 250 WORDS)

Pierachille Santus,1,2 Dejan Radovanovic,1,2 Silvia Di Marco,3 Vincenzo Valenti,4,5 Rita Raccanelli,1,2 Francesco Blasi,6,7 Stefano Centanni,8,9 Maurizio Bussotti31Department of Health Sciences, University of Milan, 2Pulmonary Rehabilitation Unit, Fondazione Salvatore Maugeri Scientific Institute of Milan-IRCCS, 3Cardiological Rehabilitation Unit, Fondazione Salvatore Maugeri Rehabilitation Institute of Milan-IRCCS, 4Department of Biomedical Sciences for Health, University of Milan, 5Respiratory Unit, Policlinico San Donato-IRCCS, San Donato Milanese, 6Department of Pathophysiology and Transplantation, University of Milan, 7IRCCS Fondazione Ospedale Maggiore Policlinico Cà Granda Milan, 8Department of Health Sciences, University of Milan, 9Respiratory Unit, Ospedale San Paolo, Milan, ItalyBackground: COPD is often associated with cardiovascular comorbidity. Treatment guidelines recommend therapy with bronchodilators as first choice. We investigated the acute effect of single-dose indacaterol on lung hyperinflation in COPD subjects, for the first time evaluating the potential effects on right heart performance.Methods: In this Phase IV, randomized, interventional, double-blind, crossover clinical study, we recruited 40 patients (50–85 years of age) with stable COPD. Patients were treated with 150 µg indacaterol or placebo and after 60 minutes (T60) and 180 minutes (T180) the following tests were performed: trans-thoracic echocardiography (TTE), plethysmography, diffusing capacity of the lung for carbon monoxide, saturation of peripheral oxygen, and visual analog scale dyspnea score. Patients underwent a crossover re-challenge after a further 72 hours of pharmacological washout. All TTE measurements were conducted blindly by the same operator and further interpreted by two different blinded operators. Consensus decisions were taken on every value and parameter. The primary outcome was the effect of the reduction of residual volume and functional residual capacity on right heart systolic and diastolic function indexes evaluated by TTE in patients treated with indacaterol, as compared to placebo.Results: Vital capacity, inspiratory capacity, and forced expiratory volume in 1 second were significantly increased by indacaterol, when compared with placebo, while residual volume, intrathoracic gas volume, and specific airway resistance were significantly reduced in patients treated with indacaterol. Tricuspid annular plane systolic excursion was significantly increased versus placebo, paralleled by an increase of tricuspid E-wave deceleration time. The cardiac frequency was also significantly reduced in indacaterol-treated patients.Conclusion: Indacaterol significantly reduces lung hyperinflation in acute conditions, with a clinically relevant improvement of dyspnea. These modifications are associated with a significant increase of the right ventricular compliance indexes and may have a role in improving left ventricular preload leading to a reduction in cardiac frequency.Keywords: lung deflation, bronchodilator, cardiac performance, right ventricular function, echocardiography

The pathogenesis of sarcoidosis is not yet known. On the basis of seroepidemiological data, an association between Chlamydia pneumoniae infection and sarcoidosis has been suggested, but so far no study has addressed the direct detection of this agent in the affected tissues. The aim of the present study was to detect C. pneumoniae deoxyribonucleic acid (DNA) within sarcoid tissue specimens by means of a two-step polymerase chain reaction. Lung biopsy specimens of 33 patients with histologically confirmed pulmonary sarcoidosis and 21 control lung biopsies or pathology specimens of patients with pulmonary carcinoma or emphysema were retrospectively analysed. A nested polymerase chain reaction was applied using two sets of primers designed to detect a fragment of the 16 strand ribosomal ribonucleic acid (rRNA) gene of C. pneumoniae. The results of the study failed to demonstrate the presence of C. pneumoniae in biopsy specimens of sarcoid tissue and in the control lung biopsies or pathology specimens. Our results, therefore, tend to rule out the possibility of a direct involvement of Chlamydia pneumoniae in the pathogenesis of sarcoidosis.

Background: A study was undertaken to evaluate Chlamydia pneumoniae chronic infection, other respiratory infections, and functional impairment in patients with chronic bronchitis (stage 1) and to examine chronic C pneumoniae infection, rate of acute exacerbations of chronic bronchitis, and rate of C pneumoniae eradication following antibiotic treatment (stage 2). Methods: In the stage 1 study respiratory specimens from 42 patients with steady state chronic bronchitis were analysed for Gram staining, sputum culture, and C pneumoniae DNA detection by nested touchdown polymerase chain reaction (PCR). On the basis of the results of stage 1, a second population of 141 consecutive patients with steady state mild to moderate chronic bronchitis (FEV1 ≥50% predicted) was studied. On admission, at regular intervals, and at exacerbation all patients underwent serological testing for C pneumoniae (microimmunofluorescence) and a nested touchdown PCR to detect C pneumoniae DNA was performed on peripheral blood mononuclear cells (PBMCs). Patients were assessed over a 12 month period. Information regarding the previous 12 months was taken from medical records. Results: Chronic colonisation of the sputum with C pneumoniae was significantly associated with lower FEV1 and greater airway bacterial colonisation. On admission to the stage 2 study, 80 patients were PCR negative and 61 were PCR positive. Over the 2 years a mean (SD) of 1.43 (1.32) acute exacerbations occurred in PCR negative patients and 2.03 (1.21) in PCR positive patients (p

The development and validation study of the Clinical Chronic Obstructive Disease (COPD) Questionnaire (CCQ) has recently been published in this journal. The CCQ is the first questionnaire that incorporates both clinician and patient guideline goals in the clinical control evaluation of patients with COPD in general clinical practice. The aim of this study is the validation of the CCQ questionnaire in Italian, in specific pulmonary disease clinical practice. Validity was tested on a population of healthy subjects and patients with COPD, using the Italian validated version of the Short Form Health Survey (SF-36) and guideline recommended routine measurement in COPD patients (FEV1, FVC, BMI and functional dyspnoea). Test-retest reliability was tested by re-administering the CCQ after 2 weeks. Responsiveness was tested by re-administering the CCQ after three weeks of hospital pulmonary rehabilitation. Distance walked and Borg breathlessness rating were measured at the end of the six-minute walking test (6 MWT), before and after rehabilitation. Cross-sectional data were collected from 175 subjects (55 healthy; 40 mild-moderate, 50 severe and 25 very severe COPD). Cronbach's alpha was high (0.89). The CCQ scores in patients were significantly worse than in healthy subjects. The CCQ total score in patients with COPD was significantly worse in those with BMI < = 21. Significant correlations were found between the CCQ total score and domains of the SF-36 (rho = -0.43 to rho = -0.72). The correlation between the CCQ and FEV1 % predicted was rho = -0.57. The correlation between the CCQ and MRC was rho = 0.63. Test-retest reliability was determined in 112 subjects over a period of two weeks (Intra Class Coefficient = 0.99). Forty-six patients with COPD showed significant improvement in CCQ scores, distance-walked and Borg breathlessness rating after 3 weeks of pulmonary rehabilitation, indicating CCQ responsiveness. The CCQ is self-administered and has been specially developed to measure clinical control in patients with COPD. Data support its validity, reliability and responsiveness in Italian and in specific pulmonary disease clinical practice.

Recent reports suggest an association between Chlamydia pneumoniae and Helicobacter pylori bacteria and atherosclerosis. We studied 51 patients (mean age, 68.3 years) who underwent abdominal aortic aneurysm surgery. For each patient we performed a microimmunofluorescence test for immunoglobulin G (IgG), IgA, and IgM antibodies to C. pneumoniae specific antigen (TW-183). Anti-H. pylori antibodies were determined by means of an EIA-G test. Each aortic aneurysm surgical specimen was sampled into multiple sections of 0.3 cm2 each and frozen at -20 degrees C. Two samples of each aneurysm were used for a nested PCR with two sets of C. pneumoniae and two sets of H. pylori specific primers. Specimens were treated with a solution containing 20 mM Tris-HCl, Tween 20-Nonidet P-40 (0.5% [vol/vol] each), and 100 micrograms of proteinase K per ml and incubated at 60 degrees C for 1 h and at 98 degrees C for 10 min. DNA was extracted twice with phenol-chloroform-isoamylic alcohol and precipitated with sodium acetate-ethanol by standard methods. Forty-one patients were seropositive for C. pneumoniae with past-infection patterns in 32 patients (16 < or = IgG < 512; 32 < or = IgA < 256) and high antibody titers in 9 patients (IgG > or = 512). In 26 of 51 patients, C. pneumoniae DNA was detected in aortic aneurysm plaque specimens. Of these patients, 23 had a serologic past-infection pattern, 2 had an acute reinfection pattern, and 1 was seronegative. Forty-seven of 51 patients were seropositive for H. pylori. In all cases PCR showed no evidence of H. pylori presence in plaque specimens. This study provides data on a possible C. pneumoniae involvement in the pathogenesis of aortic aneurysm and additional evidence for an association between this agent and atherosclerosis. Conversely, notwithstanding a high H. pylori seroprevalence observed, our results tend to rule out the possibility of a direct involvement of H. pylori in atherosclerosis.