Comparison of anti-inflammatory and clinical effects of beclomethasone dipropionate and salmeterol in moderate asthma

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Some factors influencing quality of spontaneous or induced sputum for inflammatory cell analysis

predict the quality of the sputum samples obtained in a large group of asthmatic subjects. Methods. We compared the presence of sputum productive cough in the days preceding the test, easiness in expectoration during the test, and sputum macroscopic aspect (presence of visible plugs) with the quality of slides obtained from sputum processing. We also monitored changes in the quality in patients who repeated sputum collection several times, comparing those whose first sample was adequate with those whose first sample was inadequate. We analysed 547 sputum samples obtained from 238 asthmatic patients. Sputum was processed using the whole sample method. Results. Patients with productive cough in the days preceding the test and easy expectoration during the test produced a higher percentage of adequate samples than those without productive cough (86% vs 76%, p=0.01) and with difficulty in expectoration (85% vs 63%, p=0.0001). "Good" macroscopic samples were associated with better quality of slides (91% vs 38%, p=0.0001). Patients with inadequate first sample (n=40) had a higher percentage of inadequate samples (55%) in the subsequent tests than patients (n=115) with adequate first sample (8%). Conclusions. Patients with increased airway secretions in the days preceding the test, easy expectoration and "good" macroscopic aspect of the sputum are more likely to produce sputum sample adequate for inflammatory cell analysis. If the first sputum sample is adequate, subsequent samples are very likely to be adequate as well. If the first sputum sample is inadequate, the quality of subsequent samples cannot be predicted, since there are similar probabilities of having adequate or inadequate samples

Shadow cost of oral corticosteroids-related adverse events: A pharmacoeconomic evaluation applied to real-life data from the Severe Asthma Network in Italy (SANI) registry

Background Asthma is one of the most common non-communicable respiratory diseases, affecting about 6% of the general population. Severe asthma, even if afflicts a minority of asthmatics, drives the majority of costs of the disease. The aim of this study is to create a pharmacoeconomic model to predict the costs of corticosteroid-related adverse events in severe asthmatics and applying it to the first published epidemiologic data from the Severe Asthma Network in Italy (SANI) registry. Methods The analysis was conducted from the perspective of the Italian National Healthcare System (INHS). Model inputs, derived from literature, included: asthma epidemiology data, frequency of adverse events, percentage of severe asthma treated with OCS and adverse event cost (Diagnosis-Related Group (DRG) national tariffs). We estimated costs per different patient groups: non-asthma controls, mild/moderate and severe asthmatics. Final results report estimated direct cost per patient and total direct cost for overall target population, showing economic impact related to corticosteroid complication. Results Based on epidemiological data input, in Italy, asthmatic subjects resulted about 3,999,600, of which 199,980 with severe asthma. The number of patients with severe asthma OCS-treated was estimated at 123,988. Compared to the non-asthma control cohort and to that with moderate asthma annual cost per severe asthmatic patient resulted respectively about \u20ac892 and \u20ac606 higher, showing a corticosteroids shadow cost ranging from 45% to 30%. Applying the cost per patient to the target population identified for Italy, the budget impact model estimated a total annual cost related to OCS-related adverse events of \u20ac242.7 million for severe asthmatics. In respect with non-asthmatic and moderate population, an incremental expenditure of about \u20ac 110.6 million and \u20ac75.2, respectively, were shown. Conclusions Our study provides the first estimates of additional healthcare costs related to corticosteroid induced adverse events in severe asthma patient. Budget impact model results highlighted the relevant economic impact of OCS-related adverse events in severe asthma patients. The future extrapolation of additional data from SANI registry will support the development of a model to investigate the role of corticosteroids sparing drugs

SANI-Severe Asthma Network in Italy: a way forward to monitor severe asthma

Even if severe asthma (SA) accounts for 5-10% of all cases of the disease, it is currently a crucial unmet need, owing its difficult clinical management and its high social costs. For this reason several networks, focused on SA have been organized in some countries, in order to select these patients, to recognize their clinical features, to evaluate their adherence, to classify their biological/clinical phenotypes, to identify their eligibility to the new biologic therapies and to quantify the costs of the disease. Aim of the present paper is to describe the ongoing Italian Severe Asthma Network (SANI). Up today 49 centres have been selected, widespread on the national territory. Sharing the same diagnostic protocol, data regarding patients with SA will be collected and processed in a web platform. After their recruitment, SA patients will be followed in the long term in order to investigate the natural history of the disease. Besides clinical data, the cost/benefit evaluation of the new biologics will be verified as well as the search of peculiar biomarker(s) of the disease

Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma.

The present study was designed to compare the fixed combination of beclomethasone and formoterol in a hydrofluoroalkane Modulite (Chiesi Farmaceutici, Parma, Italy) pressurised metered-dose inhaler (pMDI), with a combination of budesonide and formoterol administered via a Turbuhaler (AstraZeneca, Lund, Sweden) dry powder inhaler (DPI). This was a phase III, multinational, multicentre, double-blind, double-dummy, randomised, two-arm parallel groups, controlled study design. After a 2-week run-in period, 219 patients with moderate-to-severe asthma were randomised to a 12-week treatment with beclomethasone 200 microg plus formoterol 12 microg b.i.d. delivered via a pMDI or budesonide 400 microg plus formoterol 12 microg b.i.d. delivered via a DPI. The analysis of noninferiority on primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups. A statistically significant improvement from baseline in lung function, symptoms and rescue medication use was observed in both groups at all time-points. No differences were observed between treatments in either rate of asthma exacerbations or frequency of adverse events. The new fixed combination of beclomethasone and formoterol in hydrofluoroalkane Modulite pressurised metered-dose inhaler is equivalent to the marketed combination of budesonide and formoterol in terms of efficacy and tolerability profile

Natural exposure to pollen reduces the threshold but does not change the pattern of response to the allergen in allergic subjects

AbstractIt is known that exposure to seasonal allergen in sensitized asthmatics increases non-specific bronchial responsiveness, but it is controversial if exposure to seasonal allergen influences the presence and the severity of the late asthmatic response (LAR) to allergen.Fifteen asthmatic subjects sensitized to grass pollen performed a specific bronchial provocative test (sBPT) with Phleum pratensis extract before and during the pollen season. Changes of methacholine were also assessed.Allergen PD20FEV1significantly decreased during the pollen season with respect to outside (allergen PD20FEV1, geometric mean: 0·10 vs. 0·23 biological units;P<0·05), but the pattern of specific airway response did not change. Particularly, a consistent LAR was observed in three subjects outside the pollen season and in two subjects during the pollen season. Seven subjects with isolated early asthmatic response (EAR) outside the season did not show LAR after allergen inhalation during the pollen season. However, four of five subjects with slight LAR outside the pollen season (Δ FEV1% between 15 and 20%) lost LAR during season. Methacholine sensitivity increased slightly but significantly from outside to during the pollen season. This increase was greater in subjects with LAR outside the pollen season.The natural exposure to pollen induces an increase in bronchial sensitivity to allergen in sensitized subjects, but it does not induce LAR in subjects without LAR outside the pollen season