Feasibility and validation of telespirometry in general practice: The Italian "Alliance" study.

INTRODUCTION: At variance from office spirometry, telespirometry has not been tested as a tool for improving the ability of general practitioners (GPs) to manage chronic airway diseases. METHODS: After adequate training, 937 Italian GPs agreed to perform telespirometry in subjects attending their clinics who had risk factors, persistent respiratory symptoms, or a previous diagnosis of asthma or COPD. Each subject performed at least three forced expiratory manoeuvres using a turbine spirometer. Traces were sent by telephone to a Telespirometry Central Office, where they were interpreted by a pulmonary specialist, according to defined criteria. The result was sent in real time to the GP to assist the management of the patient. RESULTS: During 2 years, 20,757 telespirometries were performed, with a mean of 22.2+/-25.2 examinations for each GP. 70% of the tests met the criteria for good or partial co-operation, allowing spirometric abnormalities to be detected in more than 40% of the tracings. The rate of telespirometries that could not be evaluated at all was reasonably low (9.2%). For a subset of the telespirometries, a comparison between acceptability criteria for telespirometry and those recommended for laboratory (ATS) or office spirometry showed that the majority of telespirometries with good co-operation satisfied completely, or with minor deviations, the ATS and Office criteria. CONCLUSIONS: Telespirometry was well accepted by Italian GPs, who obtained acceptable screening traces in a large percentage of subjects. Therefore it might be considered a useful alternative to office spirometry in improving the management of chronic airway diseases by GPs.

Adjustable maintenance dosing with budesonide/formoterol in a single inhaler provides effective asthma symptom control at a lower dose than fixed maintenance dosing.

Asthma guidelines suggest a stepwise approach to maintenance pharmacological treatment of persistent asthma until control is attained, and a 3 month review of the fixed maintenance dosing for step-up or step-down adjustment. This 12-week study compared the efficacy and safety of budesonide/formoterol in a single inhaler (Symbicort Turbuhaler 160/4.5 or 80/4.5 microg) given as adjustable maintenance or fixed maintenance dosing. Patients (n = 2358) were randomised to budesonide/formoterol fixed maintenance dosing (two inhalations bid) or adjustable maintenance dosing (two inhalation bid; stepping up to four inhalations bid if asthma worsened for a maximum of 14 days; stepping down to two inhalations once nocte or one inhalation bid if symptoms were controlled) for 12 weeks, following a 4-week run-in period on budesonide/formoterol two inhalations bid. Primary efficacy variables were frequency of asthma exacerbations and changes in patients' asthma symptom severity. Secondary variables were asthma control, safety and health economics. Both adjustable maintenance dosing and fixed maintenance dosing were associated with similar low frequency of exacerbations (5% both groups; ns) and similarly improved lung function, with similarly fewer nocturnal awakenings and less asthma symptoms compared with the mean value of the run-in period. However, patients on adjustable maintenance dosing used 24% fewer study drug compared with fixed maintenance dosing (2.95 versus 3.86 inhalations daily; p < 0.0001) and incurred in a significant (p <0.0001) reduction in total costs (direct+indirect) compared with fixed maintenance dosing. In conclusion, adjustable maintenance dosing with budesonide/formoterol effectively controls asthma at a reduced drug load with lower costs than fixed maintenance dosing.

Serological study on Chlamydophila pneumoniae in patients with community-acquired pneumonia.

This study aimed to evaluate the incidence of Chlamydophila pneumoniae antibodies in patients with community acquired pneumonia (CAP) by a new ELISA test (EIA CP-IgG, IgA, IgM--Eurospital, Trieste, Italy). From January 1999 to July 2001 141 patients with clinical signs of CAP were enrolled in sixteen Italian Hospitals. Specific IgM and IgG antibodies anti-C. pneumoniae in serum and IgA in both serum and sputum were detected. At a primary inspection (time T-0) serum and sputum samples were taken from 115/141 patients, whereas serum was collected from only 100/141 patients after 30 days (time T-30). At T-0 24/115 (20.8%) patients showed serological markers thus suggesting an acute C. pneumoniae infection. In 23/24 patients the overall serological pattern found at T-0 was confirmed at T-30. In 32/115 patients (27.8%) serological markers of C. pneumoniae past infection were found positive and were confirmed 30 days later. These data support the role of C. pneumoniae as an important aetiological agent of CAP throughout different geographic areas of Italy. The test was suitable for the laboratory diagnosis of C. pneumoniae infection. In particular, the presence of specific IgA anti- C. pneumoniae in both serum and sputum proved useful to define different stages and evolution of infection.

EDU-CARE, a randomised, multicentre, parallel group study on education and quality of life in COPD.

Chronic obstructive pulmonary disease (COPD) represents one of the main causes of morbidity and mortality in the western world. Unfortunately, its therapy is largely palliative, the key aims of treatment being to reduce exacerbations, minimise symptoms, and improve patients' ability to perform their usual daily activities. In the absence of true disease-modifying treatments, the concept of rehabilitation has become important. In addition, it has been shown that educational and self-management programmes may play a role in the general treatment of COPD patients. This study was promoted by the Italian Association of Hospital Pulmonologists (AIPO) with the aim to verify changes and improvements induced by an educational programme validated by AIPO in patients with COPD. Edu-Care is a 6-month, multicentre, randomised, controlled, parallel-group study. In addition to treatment within the usual therapeutic schemes for COPD, patients were randomised to either the 'Educational' group, i.e. to receive a formal and structured educational programme, or the 'Normal General Advice' group, i.e. to receive the usual general advice given by general practitioners on life-style and on the disease's risk factors and treatment. A number of evaluations were performed: pulmonary function test, walking distance, quality of life, locus of control, register of number of exacerbations and hospital admissions. To date, of the 1,230 patients enrolled interim data are available from 1,003 patients. Males represent 85% of the study population. Smoking habit is quite a common status (21%). In the year prior to enrolment 34% of patients had one exacerbation, 49% 2-3 exacerbations, and 17% more than 3 exacerbations. Seventy-two percent of patients were not hospitalised over the year prior to enroLlment, while 22% were hospitalised once and 6% had more than 2 hospitalisations. Edu-Care is the first large study aimed to evaluate the efficacy of an educational programme for patients with COPD. AIPO wishes to make a contribution to this important field. This is the reason why Edu-Care includes a very large number of patients in numerous Italian centres throughout northern and southern Italy.

An observational study on the epidemiology of respiratory tract bacterial pathogens and their susceptibility to four injectable beta-lactam antibiotics: piperacillin, piperacillin/tazobactam, ceftazidime and ceftriaxone.

Bacterial infections of the respiratory tract account for a large proportion of total medical consultations in general practice. In recent years, antibiotic resistance has increased alarmingly in a number of bacterial species that are common causes of these infections. The aim of this observational study was to determine the antibiotic resistance of microbial agents isolated from patients with acute or acutely exacerbated respiratory infections. Subjects recruited as potential sources of bacteria were either outpatients seen in a number of specialized clinics and hospital practices, or hospitalized patients. Overall, 648 consecutive patients (67% male, mean age 48.1+/-27.0 years) with infection of the upper or lower respiratory tract were observed during a 13-month period. A total of 551 pathogenic microbial strains were isolated and tested for their in vitro susceptibility to piperacillin, piperacillin/tazobactam, ceftazidime, and ceftriaxone. Among all isolates, the four most frequent pathogens were Pseudomonas aeruginosa (132 isolates, 24%), Streptococcus pyogenes (99 isolates, 18%), Staphylococcus aureus (93 isolates, 17%), and Klebsiella pneumoniae (46 isolates, 8%). The susceptibility of gram-positive isolates ranged from 97.5% to 95.1%, and no remarkable difference was found in the antibacterial activity of tested b-lactam antibiotics. The susceptibility of gram-negative isolates to piperacillin and piperacillin/tazobactam was also similar: 96.5% and 97.1%, respectively. In contrast, differences were found between piperacillin (or piperacillin/tazobactam) and either ceftazidime (p=0.003) or ceftriaxone (p<0.0003) in gram-negative isolates. We conclude that, despite the extensive use of beta-lactam antibiotics (piperacillin, ceftazidime, and ceftriaxone) in medical practice during the past three decades, the susceptibility of the most common pathogens involved in the etiology of upper and lower respiratory tract infections to these antibiotics is still high. In particular, bacterial resistance developed by gram-positive organisms against piperacillin is negligible and not alarming.

Asthma controller therapy: role of antileukotrienes, a new therapeutic class.

Asthma is a chronic disease and should be treated with both controller and reliever drugs. Asthma controller therapy is not used sufficiently widely, probably due to low compliance with inhaled drugs, lack of response in some patients to low-medium doses of inhaled steroids and possible adverse events. This review analyses a new class of antiasthmatic drugs, leukotriene receptor antagonists (antileukotrienes). At present, two antileukotrienes are available in Italy: zafirlukast and montelukast. Antileukotrienes improve symptoms and also inhibit the effects of some of the inflammatory mediators involved in the pathogenesis of asthma; therefore, antileukotrienes may be used in monotherapy. In addition, the oral administration route is an advantage for compliance. Antileukotrienes significantly improve pulmonary function, asthma symptoms and inhaled and oral steroid and short-acting beta 2-agonist use. Moreover, antileukotrienes produce a 50% mean reduction in the incidence of asthma exacerbations compared with placebo. From the economic point of view, asthma controller therapy using antileukotrienes is associated with a > 50% (compared with placebo) reduction in healthcare costs (hospitalization due to asthma exacerbation, healthcare contact and absenteeism from work or school), which globally account for 93% of asthma-related costs. Antileukotrienes are indicated in the treatment of persistent mild-to-severe asthma, seasonal allergic asthma, exercise-induced asthma and aspirin-induced asthma. Antileukotrienes are well tolerated independently of the duration of treatment and the incidence of the observed adverse events is substantially similar to that observed using placebo. Owing to good tolerability and compliance and the economic advantages, these agents may be considered a valid therapeutic option for the control and management of asthma as a chronic disease.

Multicenter randomized trial comparing meropenem (1.5 g daily) and imipenem/cilastatin (2 g daily) in the hospital treatment of community-acquired pneumonia.

An open, multicenter study with 144 patients, aged between 18 and 94 years, was performed to compare the efficacy and safety of meropenem with imipenem/cilastatin in the hospital treatment of community-acquired pneumonia. Patients were randomized to receive either intravenous meropenem (500 mg every 8 h) or intravenous imipenem/cilastatin (1,000 mg every 12 h). The primary end point was considered to be clinical efficacy and the secondary end points were bacteriological response and safety assessment. At the end of therapy, cure or improvement in signs and symptoms as a satisfactory clinical response was observed in 57 of 64 (89.1%) meropenem-treated patients and in 60 of 66 (90.9%) imipenem/cilastatin patients. The mean duration of treatment was 10 days for meropenem and 9.7 days for imipenem/cilastatin. In patients who were followed up for weeks 2-4, the response was satisfactory (100%) for both treatments. A satisfactory bacteriological response, defined as either presumed or confirmed eradication of all pathogens, was found in eight patients who had received meropenem and in 14 patients who had received imipenem/cilastatin. Response was considered satisfactory in 100% of the meropenem group and in 92.9% of the imipenem/cilastatin group and at follow-up, it was 100% for both treatments. Drug-related adverse events were reported in three (4.2%) meropenem-treated patients and in eight (11.0%) imipenem/cilastatin-treated patients. None of these events was classified as serious. The results of this study show that the clinical and bacteriological efficacy and tolerability of meropenem (500 mg every 8 h) are similar to that of imipenem/cilastatin (1,000 mg every 12 h) in the hospital treatment of community-acquired pneumonia.