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Asthma affects approximately 5 million children in the United States. This disease results in billions of dollars of expenditures for hospitalizations, emergency admissions, medications, equipment, and indirect costs such as lost work productivity. This article describes how children with asthma received in-depth evaluations and education, long-term control medications, and Air Watch monitoring to improve treatment adherence, asthma control, and asthma severity. Study patients (n = 99) received patient care and education according to the protocols of the Pediatric Asthma Clinic, Lovelace Health Systems (Albuquerque, NM). All enrolled patients were prescribed fluticasone propionate and salmeterol xinafoate based on asthma severity and the National Institutes of Health guidelines. In addition, each patient used the AirWatch electronic airway monitoring system. Patients (n = 80) who participated in the study for 6 months demonstrated overall improved adherence to prescribed medications and better control of asthma. Adherence to the AirWatch system decreased over time, most likely due to improvements in the way the patients felt. In conclusion, treatment adherence, asthma control, and asthma severity can be improved with comprehensive patient education, long-term control medications, and objective home pulmonary function monitoring.
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A combination of salmeterol and fluticasone propionate (SAL/FP) has been shown to be effective in the treatment of asthma. We compared the efficacy and tolerability of SAL/FP (50/250 μg) with fluticasone propionate (FP) 250 μg administrated twice daily for 2 weeks in treating patients with mild to moderate asthma.
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Specialist allergy unit in a university hospital.
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This study compared the bronchodilator efficacy and safety of indacaterol with placebo, salbutamol and salmeterol, in patients with persistent asthma, at single therapeutic and supratherapeutic doses.
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There were no cases of RADS diagnosed at 6-month follow-up evaluations.
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The long-acting beta2 sympathomimetics salmeterol and formoterol have been presumed to exert their prolonged action either by binding to an accessory binding site ("exo-site") near the beta2 adrenoceptor or by their high affinity for beta2 adrenoceptors and correspondingly slow dissociation. Whereas most studies with salmeterol had been done in intact tissues, which have slow diffusion and compartmentation of drugs in lipophilic phases, that restrict drug access to the receptor biophase, we used purified receptor membranes from rat lung and disaggregated calf tracheal myocytes as model systems. Binding experiments were designed to measure the slow dissociation of agonists by means of delayed association of (-)-[125I]iodopindolol. Rat lung membranes were pretreated with high concentrations of agonists (salmeterol, formoterol, isoprenaline) before dissociation was induced by 50-fold dilution. Half-times of association of (-)-[125I]iodopindolol remained unchanged compared with untreated controls, indicating that dissociation of agonists occurred in less than 2 min. Adenylyl cyclase experiments were designed to determine the on and off kinetics of agonists to beta2 adrenoceptors by measuring the rate of receptor-induced cyclic AMP (cAMP) formation. Experiments were performed in tracheal membranes characterized by high Vmax values of cAMP formation. Adenylyl cyclase activation occurred simultaneously with the addition of the agonist, continued linearly with time for 60 min, and ceased immediately after the antagonist was added. Similarly, when receptor membranes were preincubated in a small volume with high salmeterol concentrations, there was a linear increase in cAMP formation, which was immediately interrupted by a 100-fold dilution of the reaction mixture. This militates against the exo-site hypothesis. On the other hand, dissociation by dilution was much less when membranes were preincubated with a large volume of salmeterol at the same concentration, indicating that physicochemical effects, and not exo-site binding, underlie its prolonged mode of action.
The toll-like receptors (TLRs) are a key component of host defense in the respiratory epithelium. Cigarette smoking is associated with increased susceptibility to infection, while COPD is characterised by bacterial colonisation and infective exacerbations. We found reduced TLR4 gene expression in the nasal epithelium of smokers compared with non-smoking controls, while TLR2 expression was unchanged. Severe COPD was associated with reduced TLR4 expression compared to less severe disease, with good correlation between nasal and tracheal expression. We went on to examine the effect of potential modulators of TLR4 expression in respiratory epithelium pertinent to airways disease. Using an airway epithelial cell line, we found a dose-dependent downregulation in TLR4 mRNA and protein expression by stimulation with cigarette smoke extracts. Treatment with the corticosteroids fluticasone and dexamethasone resulted in a dose-dependent reduction in TLR4 mRNA and protein. The functional significance of this effect was demonstrated by impaired IL-8 and HBD2 induction in response to LPS. Stimulation with salmeterol (10-6 M) caused upregulation of TLR4 membrane protein presentation with no upregulation of mRNA, suggesting a post-translational effect. The effect of dexamethasone and salmeterol in combination was additive, with downregulation of TLR4 gene expression, and no change in membrane receptor expression. Modulation of TLR4 in respiratory epithelium may have important implications for airway inflammation and infection in response to inhaled pathogens.
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Thirty-one clinical centers in the United States.
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Two hundred eighty-five children aged 6 to 14 years with mild-to-moderate persistent asthma were randomized to receive one of 3 controller regimens and completed daily symptom diaries for 48 weeks. Diary responses were analyzed for the frequency and consequences of NASRAs.
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No statistically significant associations between Arg16Gly genotypes and serial FEV(1) clinical responses to SAL and FSC were observed following acute assessment. In addition, the FEV(1) response was preserved following 12 weeks of treatment with SAL and FSC and was not altered by Arg16Gly genotypes analyzed. These results may not be generalizable to other ethnic groups since they are derived predominantly from Caucasians.
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Preclinical studies have shown both salmeterol and formoterol to be potent and selective at beta 2-adrenoceptors but to have different mechanisms and durations of action. The pharmacologic profiles of these drugs result from prolonged activation of beta 2-adrenoceptors, leading to long-lasting bronchodilation (with no evidence of tolerance or tachyphylaxis) and additional nonbronchodilator properties. The long-acting beta 2-agonists represent a therapeutic advance in the management of asthma.
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Lung function measurements including FEV(1), PEF, specific airways conductance (sGaw) and maximum expiratory flow at 25-75% of vital capacity were measured at baseline, 2, 12, 16, 20 and 24 h.
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Eotaxin-1 (CCL11), an eosinophil-specific C-C chemokine, is a potent chemoattractant for mobilization of eosinophils into airways after allergic stimulation. Eotaxin-1 recruits eosinophils into inflammatory sites, and may play a role in the pathogenesis of asthma. Formoterol and salmeterol are two inhaled long acting beta(2) adrenoceptor agonists (LABAs), widely used for the local treatment of asthma. However, little is known about their effects on the eotaxin-1 expression of bronchial epithelial cells. BEAS-2B cells were stimulated by adding IL-4 with or without 2 h pre-treatment of formoterol or salmeterol. The protein and mRNA expression of eotaxin-1 were measured by ELISA assay and real-time PCR, respectively. Effects of formoterol and salmeterol on nuclear and cytosolic pSTAT-6 expression were evaluated by Western blot and immunofluorescence study. Formoterol and salmeterol (10(-7)-10(-10) m) significantly down-regulated IL-4- induced eotaxin-1 expression in BEAS-2B cells. A specific beta(2) adrenoceptor antagonist (ICI 118,551) reversed their suppression of eotaxin-1 production. Forskolin, an cAMP activator, could also suppress the expression of eotaxin-1 by IL-4 in a dose dependent manner (10(-7)-10(-10 )m). The western blot and immunofluorescence studies demonstrated that formoterol 10(-7 )m suppressed the nuclear expression of pSTAT-6. Formoterol and salmeterol, two inhaled long-acting beta(2) agonists, down-regulated IL-4- induced eotaxin-1 expression in BEAS-2B cells. The effect was mediated via the beta(2) adrenoceptor, and cAMP. Formoterol significantly down-regulated pSTAT6 at higher concentration, and further turned off the IL-4 signaling pathway.
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Management plans for childhood asthma show limited success in optimising asthma control. The aim of the present study was to assess whether a treatment strategy guided by airway hyperresponsiveness (AHR) increased the number of symptom-free days and improved lung function in asthmatic children, compared with a symptom-driven reference strategy. In a multicentre, double-blind, parallel-group, randomised, 2-yr intervention trial, 210 children (aged 6-16 yrs) with moderate atopic asthma, selected on the basis of symptom scores and/or the presence of AHR, were studied. At 3-monthly visits, symptom scores, forced expiratory volume in one second (FEV(1)) and methacholine challenge results were obtained, and medication (five levels of fluticasone with or without salmeterol) adjusted according to algorithms based on symptom score (reference strategy, n = 104) or AHR and symptom score (AHR strategy, n = 102). After 2 yrs, no difference was found in the percentage of symptom-free days between treatment strategies. Pre-bronchodilator FEV(1) was higher in the AHR strategy (2.3% predicted). This was entirely explained by a gradual worsening of FEV(1) in a subgroup of 91 hyperresponsive children enrolled with low symptom scores (final difference between study arms was 6%). Asthma treatment guided by airway hyperresponsiveness showed no benefits in terms of number of symptom-free days, but produced a better outcome in terms of pre-bronchodilator forced expiratory volume in one second in allergic asthmatic children, especially those characterised by low symptom scores despite airway hyperresponsiveness.
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There were no significant between-group differences in asthma exacerbations (primary variable), asthma symptoms, or lung function during the 7-month treatment period. Less study drug (inhalations per day, P < .001) was used with adjustable-dose versus fixed-dose budesonide/formoterol. All treatments were well tolerated.
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Salmeterol xinafoate is a long-acting, highly selective, beta2-adrenergic agonist that produces bronchodilation and clinically significant improvement in pulmonary function for up to 12 hours in patients with asthma.
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We conducted the review according to standard procedures expected by the Cochrane Collaboration. We obtained unpublished data on mortality and serious adverse events from the sponsors, and from FDA submissions. We assessed the quality of evidence according to GRADE recommendations.
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Using salmeterol xinafoate (SX) as an active pharmaceutical ingredient, the effects of carrier lactose particle type, total lactose fines content and device resistance on dry powder inhaler performance were investigated in vitro. To mimic drug levels in commercial preparations, interactive mixtures containing 0.58% w/w SX were prepared by low shear tumble mixing. Three types of milled inhalation grade lactose were used (Lactohale(®) LH 200, Respitose(®) ML006 and ML001) and the concentration of fine lactose (Lactohale(®) 300) added was varied. The in vitro deposition of each mixture was studied using a next generation impactor and inhaler devices exhibiting different resistances, Rotahaler(®)80% ED and MMAD ± GSD between 1-5 μm. The results confirmed the factors under investigation to be important determinants of product performance, but demonstrated using realistic conditions how individual factor impact may be enhanced or mitigated by inter-dependency.
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Lung function is a major criterion used to assess asthma control. Fluctuation analyses can account for lung function history over time, and may provide an additional dimension to characterise control. The relationships between mean and fluctuations in lung function with asthma control, exacerbation and quality of life were studied in two independent data sets.
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Combination treatment with steroids and long-acting beta2-agonists provides greater asthma control than simply increasing the dose of steroids.
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To characterize the surface thermodynamic properties of two polymorphic forms (I and II) of salmeterol xinafoate (SX) prepared from supercritical fluids and a commercial micronized SX (form 1) sample (MSX).
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Omalizumab is an anti-IgE monoclonal antibody available since 2006 for the treatment of GINA step 4 asthma. We studied a 41-year old male who has been suffering from severe steroid-resistant asthma with severe co-morbidity and treated with Omalizumab. He was found to be non-responder to the treatment until the 48th week, starting from which we began to see a distinct improvement in the symptoms and all the correlated parameters, in addition to remission of the co-existent allergy to milk.
The bronchodilating effect and other related pharmacological properties of SN-408 were studied in comparison with those of isoproterenol, salbutamol and procaterol. SN-408 caused concentration-dependent relaxation of isolated guinea pig trachea via the beta 2-adrenoceptor. The order of relaxation potency was: procaterol greater than SN-408 greater than or equal to isoproterenol greater than salbutamol, but the duration of the action of SN-408 was far longer than those of other beta-agonists. Positive chronotropic and inotropic actions of SN-408 in isolated guinea pig right atria and left atria were less potent than those of other beta-agonists. In isolated guinea pig lung tissues, SN-408 increased cyclic AMP contents. Also in vivo, SN-408 showed dose-dependent bronchodilating action by i.v. administration in anesthetized guinea pigs and by inhalation in conscious guinea pigs. Bronchodilating actions of SN-408 were less potent than those of procaterol and isoproterenol, but the duration of action of SN-408 was far longer than those of other beta-agonists. SN-408 showed no evidence of the development of tolerance to the bronchodilating action. SN-408 caused small tachycardia in guinea pigs by i.v. and inhalation. SN-408 given i.v. suppressed vascular permeability in mice. These results indicate that SN-408 is a long-acting and selective beta 2-stimulant bronchodilator.
Current asthma guidelines recommend that patients are educated to adjust their medication according to their asthma severity using physician-guided self-management plans. However, many patients take a fixed dose of their controller medication and adjust their reliever medication according to asthma symptoms.