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Mean FEV(1)AUC(0-24) (the primary endpoint) improved similarly from baseline for arformoterol (0.10L) and tiotropium (0.08L) treatment groups and greater for the combined therapy group (0.22L; all p-values <0.005). Peak FEV(1), peak FVC, 24-h trough FEV(1), and inspiratory capacity also improved similarly for the mono-therapies and greatest for the combined therapy. Dyspnea (mean transition dyspnea index) improved similarly for arformoterol (+2.3) and tiotropium (+1.8) and greatest with combined therapy (+3.1; p-values <0.05). Levalbuterol use decreased for all treatment groups (range -1.8 to -2.5 actuations/day). All treatments had similar frequency of adverse events.
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A total of 2,880 maximum expiratory flow-volume curves were performed in a controlled double-blind cross-over examination designed to evaluate the bronchodilating effects of two different nebulized doses of salbutamol (1.75 and 0.875 mg) and ipratropium bromide (0.175 and 0.0875 mg) inhaled by 8 normal, 8 asthmatic, and 8 bronchitic subjects. FEV1, FVC, and flows at 50% FVC and at three fixed volumes below TLC have been measured over a period of 6 h on the maximum expiratory flow-volume curve. In the normal subjects, salbutamol seems to have a smaller bronchodilating effect than ipratropium bromide both at high and low lung volumes. After salbutamol the average initial FEV1 increased from 4.0 to 4.3 liters, whereas after ipratropium bromide it increased to 4.4 liters. In our asthmatic patients the initial response to salbutamol was much larger than to ipratropium bromide. After salbutamol FEV1 increased from 1.8 to 2.7 liters in 60 min, whereas after ipratropium bromide it increased to 2.4 liters in 120 min. In our bronchitic patients the difference between the two drugs seems to be very small. After both drugs FEV1 increased from 1.6 to 2.1 liters. The choice of drug for treatment of the condition would then depend on how well the individual patients tolerate the two drugs.
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Use of HELIOX as a driving gas for the updraft nebulization of bronchodilators during the first 2 hrs of treatment of an acute COPD exacerbation failed to improve FEV1 faster than the use of AIR. The faster improvement in FEF25-75 during the first 2 hrs of treatment was small and of uncertain clinical significance.
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Neither enantiomers of salbutamol caused a relaxant effect on the sub-maximal plateau contractile effects of carbachol; in fact, both R- and S-salbutamol induced a slight, but significant contraction (P ≤ 0.05) compared to the controls. In contrast, R-salbutamol induced a significant relaxation of bronchi pre-contracted with histamine (RAO-unaffected: 92.06% ± 2.00; RAO-affected 100.20 ± 3.99; P ≤ 0.01). S-salbutamol induced a weak relaxation (RAO-unaffected: 15.81% ± 5.65; RAO-affected 12.36 ± 5.15) when compared to that induced by papaverine. The incubation with either R- or S-salbutamol shifted rightward (P ≤ 0.001) the carbachol contraction curve in RAO-unaffected bronchi, but not in RAO-affected bronchi, compared to control tissues. R-salbutamol induced a reduction in E(max) values (C: 9.07 gr ± 0.68; R-salb.: 6.36 gr ± 0.21; P ≤ 0.01) in normal bronchi. On the contrary it reduced the histamine potency in RAO-affected bronchi (EC50 7.10 μM ± 0.35, P < 0.001). The incubation with S-salbutamol shifted leftward the histamine concentration curve in both normal bronchi (C: 7.00 μM ± 0.29; S-salb.: 2.25 μM ± 0.19; P ≤ 0.001) and bronchi from RAO-affected horses (C: 2.80 μM ± 0.26; S-salb.: 1.50 μM ± 0.80; P ≤ 0.05).
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Of the 46 children 40 succeeded in performing FOT and only 29 succeeded in performing simple spirometry. All but one of the 32 children aged 4 years and above (97%) could perform both tests. Nine of 14 children (64%) aged 4 and less could perform the FOT but only 3 (21%) could perform spirometry. Baseline values of respiratory resistance measured at 6 Hz (R6) negatively correlated with body length (r2 = 0.68, P < 0.005). Twenty-four children performed both tests before and after bronchodilator therapy. A significant concordance was found between the measured responses to bronchodilators by FOT and spirometry (P < 0.01). Only one child had a negative response by FOT but a positive response by spirometry.
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Generally the severe attack of asthma can be diagnosed without problems. Before the beginning of treatment a short history should be taken, laboratory tests should be started and a chest X-ray be ordered. The administered drugs are supposed to treat the obstruction of the airways. The inspissated endotracheal secretions are liquified and mobilised by a consequent intravenous therapy. A selective beta-2-receptor stimulans and xanthines are administered to relax the bronchospasm. In severe cases glucocorticoids are given at the same time to diminish the inflammatory edema of the bronchiolar mucosa. Antibiotics are only used if indicated, nor routinely. Sedatives should be administered very cautiously.
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Our objective was to evaluate the quality of prehospital assessment and management in pediatric asthma requiring hospitalization via a retrospective chart review. Charts were obtained from a pediatric emergency department (ED) with 24,000 annual visits. Included in the study were 27 patients less than 18 years of age with asthma requiring hospitalization, transported to the Boston City Hospital Pediatric ED by Boston Emergency Medicine Services (EMS). We found that 12 patients admitted to the pediatric intensive care unit over an 18-month period, and 15 patients admitted to the ward over a six-month period, received prehospital care from Boston EMS. Only 63% of cases (17/27) had a physical examination marker of asthma severity noted on the EMS record. Twenty-six percent of cases (7/27) did not receive O2 in the field. Thirty percent of cases (8/27) were hypoxic at ED presentation. None of the hypoxic patients had received albuterol in the field, and one did not receive O2. We conclude that further study of the prehospital assessment and management of pediatric asthma is warranted.
A previous study suggested that bronchodilators were more effective in preventing diurnal variation of peak expiratory flow rate (PEFR) in patients with chronic obstructive bronchitis than asthma (Connolly 1979). In a further investigation of 100 patients there was an association between characteristic patterns and the size of the morning dip. After the use of bronchodilators there was a residual morning dip which was large enough to produce a regular pattern in most asthmatics but few bronchitics. Response to bronchodilators during the middle of the day was a poor predictor of both the presence and size of diurnal variation of PEFR and of the efficacy of regular bronchodilator therapy. Regular assessment of PEFR and its response to bronchodilator therapy over a few days is required to assess the extent of potential variation in airway obstruction.
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The diagnosis of food allergy requires a proper anamnesis and diagnostic testing with skin prick tests with fresh foods and/or standardized allergen, or specific IgE tests. The risk of systemic reactions is of 15-23 per 100,000 skin tests performed by prick method, specifically anaphylaxis at 0.02%. This paper reports the case of four patients, who while performing prick to prick test with fresh food presented anaphylactic reaction. Implicated foods were fruits of the Rosaceae, Anacardiaceae and Caricaceae families. The severity of anaphylaxis was: two patients with grade 4, one patient grade 2 and one grade 3, all with appropriate response to drug treatment. The risk factors identified were: female sex, personal history of atopy, previous systemic reaction to Hymenoptera venom, prior anaphylaxis to prick tests to aeroallergens. We found that a history of positive skin test for Betulla v, can be a risk factor for anaphylaxis in patients with oral syndrome. During testing prick to prick with food anaphylaxis can occur, so it should be made with aerial red team on hand. The history of positivity Betulla v is an additional risk factor in these patients.
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The effects of prednisolone, theophylline or salbutamol treatment were studied on leukocyte numbers in bronchoalveolar lavage (BAL) fluid taken 72 h after ovalbumin challenge in sensitized guinea pigs. Ovalbumin challenge resulted in an approximate 3-fold increase in the number of eosinophils in BAL fluid. This increase was significantly reduced by oral administration of prednisolone (59% inhibition with 10 mg/kg x 2) theophylline (56% with 50 mg/kg x 2) but not by salbutamol (10 mg/kg x 2). A comparison with the bronchodilator potency of the above drugs indicated that in guinea pigs salbutamol appears relatively selective as a bronchodilator, prednisolone is selective as an inhibitor of eosinophilia whilst theophylline displays a balance of both activities.
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Salmeterol combined with inhaled corticosteroids decreases the risk for severe exacerbations, does not seem to alter the risk for asthma-related hospitalizations, and may not alter the risk for asthma-related deaths or intubations compared with inhaled corticosteroids alone.
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A retrospective analysis of inpatient medication orders and dosing alerts occurring during October 2011 and January, April, and July 2012 at a pediatric institution. Prescription orders and alerts were categorized by: medication class, patient age, route of administration, and month of the year.
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Compared with a standard spacer, the edible spacer delivered significantly more bronchodilator in droplets of a size likely to enter the respiratory tract. A significant bronchodilator response occurred in two out of two subjects when salbutamol was inhaled orally via the chocolate spacer. No significant bronchodilator response occurred in either subject when the spacer was eaten at the end of the study.
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Histamine is one of a range of mediators which play an important role in asthma, and the "releasability" of basophils has been shown to be upregulated in this disease. In vitro, beta 2-agonists and to a lesser extent corticosteroids have been shown to reduce histamine release. The ex vivo effects of salmeterol and inhaled corticosteroids on histamine release were studied in 78 asthmatic patients with variable disease severity and 20 control subjects. Spontaneous and anti-IgE-induced histamine release was measured in all subjects. Fifteen patients were not receiving any form of treatment, 42 were treated with inhaled corticosteroids, and 21 received inhaled corticosteroids and salmeterol. Seven patients treated with inhaled corticosteroids and seven patients treated with inhaled corticosteroids and salmeterol were tested twice to assess the effect of salmeterol on histamine release. Nine patients treated with inhaled corticosteroids were tested before and after 1 month of salmeterol treatment to determine the possible inhibition by salmeterol. Patients who were treated with inhaled corticosteroids and salmeterol showed significantly lower levels of spontaneous histamine release (median: 2.5%) than untreated (5.2%) and inhaled corticosteroids-treated asthmatics (3.4%). No tachyphylaxis to salmeterol was observed when patients were tested twice at a 3-month interval. This study suggests that salmeterol may have an additive anti-inflammatory effect with inhaled corticosteroids, although this hypothesis must be tested by further studies involving cells obtained by bronchoalveolar lavage and studies with bronchial biopsies.
There was no significant difference between the baseline performance of the four disposable models and the durable Pari LC, when measuring particle size distribution of the aerosol; the Pari LC had an output rate two to three times higher than the four disposable models. For each of the four solutes tested, there was no clinically significant change in performance for up to 100 cycles, when the nebulizers were properly cleaned between uses. Unwashed units containing tobramycin started to fail by 40 runs.
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The effect of monoamine oxidase (MAO) inhibition on maternofetal transfer of noradrenaline (NA) has been investigated in vitro using dual perfusion of isolated human placental lobules. As a first step, placental MAO content and its sensitivity to inhibition by pargyline were assessed in incubation studies of homogenates as well as during perfusion, taking rat liver as reference. Our results show that the human placenta, though it contains as great an enzyme activity as rat liver, was less sensitive to inhibition by pargyline than the latter. MAO inhibition by pargyline significantly reduced the NA clearance from maternal to fetal circulation. Thus the proportion of unmetabolized NA radioactivity in fetal venous samples decreased significantly after pargyline treatment. A concomitant rise in the proportion of mainly O-methylated metabolites was also observed. We speculate that the apparent activation of catechol-O-methyl transferase pathway, observed in our studies on MAO inhibition, may play an important role in limiting NA transfer towards the fetus in toxaemic pregnancies associated with the reduction in placental MAO.
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Selection of inhaler device type appears to influence real-world effectiveness of inhaled corticosteroids (ICS), but data are lacking on the role of inhaler device in ICS and long-acting β2-agonist (LABA) combination therapy for asthma.
Our findings demonstrate that the usual predictors of future disease activity have little predictive power when applied to a highly adherent population with persistent asthma that is receiving guidelines-based care. Thus, new predictors need to be identified that will be able to measure the continued fluctuation of disease that persists in highly adherent, well-treated populations such as the one studied.
To evaluate the use of thermal ink-jetting as a method for dosing drugs onto oral films.
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Nine children, 7-16 years of age, were studied repeatedly during an acute asthmatic attack, from acute deterioration to recovery. The transcutaneous blood gases, forced expiratory volume in 1 s (FEV1) and maximum expiratory flow when 25% of vital capacity remained to be expelled (MEF25) were monitored before and after salbutamol inhalation. The flow-volume variables were markedly impaired in the acute phase but improved gradually by the time of recovery. The transcutaneous PO2 (tcPO2) decreased in the acute and early recovery phase but improved by the late recovery phase. In the acute phase, the salbutamol inhalations increased the FEV1, indicating an improvement in central airway function, but also reduced the MEF25 and tcPO2 in some of the children. The changes in tcPO2 after the inhalations correlated with the changes in MEF25 (p < 0.001), thereby indicating a common denominator, probably the condition of the peripheral airways. In the recovery phase, the FEV1, MEF25 and tcPO2 improved after the inhalations (p < 0.05). In conclusion, transcutaneous PO2 can be used to evaluate the effects of treatment in children with acute asthmatic symptoms and may add information about peripheral airway function which may prove particularly valuable in small children where few methods are available for such measurements.
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The effects of an inspiratory manoeuvre preceding forced expiration on functional tests performed under routine conditions before and after inhalation of a bronchodilator drug (salbutamol) were assessed on 150 consecutive chronic obstructive pulmonary disease outpatients. The patients performed forced vital capacity manoeuvres either immediately after a rapid inspiration (manoeuvre no. 1) or after a slow inspiration with a 4-6 s pause (manoeuvre no. 2). Under baseline conditions, forced expiratory volume in one second (FEV1) values were 8% (% control) larger with manoeuvre no. 1 than no. 2. FEV1 values increased with salbutamol administration by approximately 8% and were, on average, still 7% larger with manoeuvre no. 1 than no. 2. The incidence of reversibility, assessed according to American Thoracic Society criteria, was 76% when manoeuvre no. 2 was selected to represent baseline conditions and manoeuvre no. 1 was chosen to represent the effects of bronchodilator administration, whereas the lowest incidence (2%) was found when manoeuvre no. 1 was selected to represent baseline conditions and manoeuvre no. 2 was chosen to represent the effects of bronchodilator administration. These results indicate that the time dependence of the forced vital capacity manoeuvre has an important impact on the assessment of routine lung function in a clinical setting and supports the notion that the time course of the inspiration preceding the forced vital capacity manoeuvre should be standardised.
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Salbutamol was found to reduce food intake in a dose-related manner. The effect was prevented by the beta-adrenolytic drugs d,1-propranolol and d,1-alprenolol. In contrast, phentolamine, penfluridol and metergoline, which block alpha-adrenergic, dopamine and serotonin receptors respectively, or bilateral lesions of the ventral noradrenergic bundles were not able to counteract salbutamol's effect. The reduction of food intake induced by salbutamol was prevented by intracerebroventricular administration of d,1-propranolol. In addition, salbutamol was found to effectively reduce the apparent motivation for food as revealed by its effect on food-rewarded runaway behaviour. This effect was also counteracted by d,1-propranolol pretreatment. The findings indicate that food intake may be reduced by peripheral administration of salbutamol and that the effect is mediated by stimulation of central beta-adrenergic sites.
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Concomitant administration of a low dose of PRED produced protection against FM-induced subsensitivity of systemic beta2-AR, as assessed by the response to inhaled salbutamol. In contrast, prednisolone did not prevent ex vivo beta2-AR downregulation despite causing significant cortisol suppression. This, in turn, suggests that there is a dissociation in the dose of PRED required to protect against beta2-AR downregulation and subsensitivity, following continuous exposure to long-acting beta2-agonist.
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A previous study on spray-drying demonstrated that it could promote the solubility of poorly water-soluble drugs using water-soluble polymers. Here, the preparation of composite particles of salbutamol sulfate (Sb) with water-insoluble polymers, such as Eudragit RS (RS) or Eudragit RL (RL) as a carrier, was examined. Despite the water insolubility of both polymers, the permeability of water was low in the former but high in the latter. We attempted to prepare controlled release composite particles by exploiting the characteristics of these carriers. The composite particles of the three components (Sb, RS, and RL) were prepared using a 4-fluid nozzle spray-dryer, and their physico-chemical and dissolution properties were compared with physical mixtures. Examination of particle morphology by scanning electron microscopy (SEM) revealed that the particles from the spray-drying process had atomized to several microns and were spherical. Analysis by X-ray diffraction and differential scanning calorimetry revealed that diffraction peaks and heat of fusion of Sb in the spray-dried samples decreased, indicating that the drug was amorphous and formed a solid dispersion. FT-IR analysis suggested that the amino group of Sb and a carbonyl group of the polymers formed a hydrogen bond. A dissolution test of Sb-RS-RL particles prepared using the 4-fluid nozzle spray-drying method showed that release rates were depressed significantly compared to the physical mixture at pH 1.2 and 6.8, and the depression was greater when RS was used instead of RL, presumably because of the permeability difference. The compression of these particles into tablets revealed that desirable controlled released dosage forms could be prepared. In addition, Sb was used to simulate an anti-asthmatic drug. For this an Andersen cascade impactor for dry powder inhalers was used to investigate delivery to the lungs.
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The purposes of this study were to (1) assess a free running test to screen for EIB, and (2) examine prevalence of and epidemiologic factors associated with EIB in high school athletes.
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1. We have measured the effect of oral salbutamol on cation transport in vivo by studying the disposition of an oral load of rubidium chloride in healthy treated volunteers and in untreated matched controls. 2. During the administration of salbutamol there was a significantly lower plasma rubidium concentration 5 h after the administration of the oral load of rubidium chloride, reflecting an increase in the net clearance of rubidium from the plasma into at least some tissues in vivo. 3. There was no difference in either intraerythrocytic rubidium concentrations or the pseudo-rate constant for erythrocyte rubidium uptake in vivo after salbutamol. 4. Ex vivo incubation of whole blood preloaded in vivo with rubidium showed that the clearance of rubidium from the plasma was inhibited by 95% in the presence of the Na+,K(+)-ATPase inhibitor digoxin. 5. These data suggest that salbutamol stimulates cation transport via Na+,K(+)-ATPase in vivo into some tissues but not into the erythrocyte. 6. This pattern of change in rubidium disposition after salbutamol is completely different from the patterns of change we have seen in patients with essential hypertension or acute manic illness. We therefore suggest that the changes in erythrocyte rubidium uptake which we have previously described in vivo in patients with essential hypertension or acute manic illness do not result from beta 2-adrenoceptor-mediated catecholamine stimulation of Na+,K(+)-ATPase.
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Intraperitoneal injection to mice of platelet-activating factor (PAF) induces severe shock symptoms, leading to death. The effects of various drugs which are potential specific or non-specific PAF inhibitors were tested. Salbutamol, a beta 2-agonist, showed a partial protection, whereas the specific PAF antagonists CV 3988 or BN 52021 induced an important beneficial action against PAF-induced lethal effects. The effects of drugs related to benzodiazepines were also studied: alprazolam administered p.o. prior to PAF challenge provides almost complete protection against PAF toxicity. Thus PAF-induced death in mice represents a useful model of systemic anaphylaxis; moreover, studies of benzodiazepine-related compounds may be interesting for investigating the mechanisms of the biological actions of PAF.
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In the control group, bronchodilator use produced a significant alteration in the resistance extrapolated to the y axis (p < 0.001), although no significant differences were observed in the slope of resistance or in dynamic compliance. Analysis of the asthma patients revealed significant differences between the prebronchodilator and postbronchodilator values for all spirometry and forced oscillation technique parameters. Values of p < 0.001 were obtained for all comparisons between the two groups.
Seven hundred sixty-four consecutive subjects with a 20% reduction or more in forced expiratory volume during the first second (FEV1) of exhalation from total lung capacity after inhaling 189 or fewer cumulative units of methacholine were included in the analysis.