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The effect of duration of administration of fluticasone propionate and salmeterol on tracheal responsiveness to ovalbumin and total and differential white blood cell in sensitized guinea pig was examined. Six groups of guinea pigs (n=7) were sensitized to ovalbumin. Three groups of them were subjected to inhaled fluticasone propionate and salmeterol, one group during sensitization (A), one group after that (for 18 days, B), and the other one during sensitization but with 18 days delay before measurements (C). Three other groups were treated with placebo in the same manner. The tracheal responsiveness to ovalbumin and total and differential white blood cells of three placebo groups were significantly higher than those of control group (P<0.001 for all cases). Tracheal responsiveness to ovalbumin and total and differential white blood cell in treated groups with fluticasone propionate and salmeterol were significantly decreased compared to those of placebo groups (nonsignificant to P<0.001). The improvement in all variables in treatment groups A and C were more pronounced than group B. The results showed that fluticasone propionate and salmeterol had a prevention effect on tracheal hyperresponsiveness to ovalbumin and lung inflammation which was more pronounced when administered during than after sensitization.
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Chronic obstructive pulmonary disease (COPD) is considered one of the most common chronic diseases in the world. It is characterized by the progressive reduction of the respiratory parameters, relatively low effectiveness of recommended treatment as well as serious prognosis especially in the group of patients with advanced disease. The beta2-adrenergic receptor agonists are first-line therapeutics in the treatment of COPD patients. Due to their diverse pharmacokinetic characteristic beta2-mimetics are recommended both for regular or "rescue" treatment to prevent or to restrain dyspnea symptoms. This paper evaluates main differences between the mechanism of action and pharmacokinetic profile of the key beta2-mimetics, discusses consequences of those diversities for their the clinical application and potential side effects.
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The objective of this study was to determine the influence of lactose carrier size on drug dispersion of salmeterol xinafoate (SX) from interactive mixtures. SX dispersion was measured by using the fine particle fractions determined by a twin stage impinger attached to a Rotahaler. The particle size of the lactose carrier in the SX interactive mixtures was varied using a range of commercial inhalation-grade lactoses. In addition, differing size fractions of individual lactose samples were achieved by dry sieving. The dispersion of SX appeared to increase as the particle size of the lactose carrier decreased for the mixtures prepared from different particle size commercial samples of lactose and from different sieve fractions of the same lactose. Fine particles of lactose (<5 microm) associated with the lactose carrier were removed from the carrier surface by a wet decantation process to produce lactose samples with low but similar concentrations of fine lactose particles. The fine particle fractions of SX in mixtures prepared with the decanted lactose decreased significantly (analysis of variance, p < 0.001) and the degree of dispersion became independent of the volume mean diameter of the carriers (analysis of variance, p < 0.05). The dispersion behavior is therefore associated with the presence of fine adhered particles associated with the carriers and the inherent size of the carrier itself has little influence on dispersion.
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In patients achieving asthma control with SFC250, stepping treatment down with SFC100 was at least as effective on lung function and symptoms as continuing SFC250, whereas FP250 was not.
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The cardiovascular component associated with chronic obstructive pulmonary disease (COPD) plays a major role in disease prognosis, accounting for 25% of the deaths. Experimental and initial clinical data suggest that beta-adrenergic agonists accelerate fluid clearance from the alveolar airspace, with potentially positive effects on cardiogenic and noncardiogenic pulmonary oedema. This pilot study investigated the acute effects of the long-acting beta-2 agonist, salmeterol, on alveolar fluid clearance after rapid saline intravenous infusion by evaluating diffusive and mechanical lung properties. Ten COPD and 10 healthy subjects were treated with salmeterol or placebo 4 h before the patient's mechanical and diffusive lung properties were measured during four non consecutive days, just before and after a rapid saline infusion, or during a similar period without an infusion.
This study tested the capability of a single 42-microgram dose of inhaled salmeterol xinafoate, a long-acting beta 2-agonist, to protect against bronchoconstrictive effects of exposure to 0.75 ppm sulfur dioxide (SO2) during exercise, for up to 24 h. Ten SO2-responsive adult volunteers with stable asthma were studied under 4 conditions of drug pretreatment/exposure, administered in random order, double-blind: salmeterol/SO2, placebo/SO2, salmeterol/clean air, and placebo/clean air. Each subject underwent 10-min exposure/exercise challenges in a chamber 1, 12, 18, and 24 h after pretreatment. Exercise ventilation rates averaged 29 L/min. Response was measured as the decrement in FEV1 between preexposure and postexposure (lowest value within 30 min). After salmeterol, mean decrement post-SO2 was 7% at 1 h and 12% at 12 h. At 18 and 24 h after salmeterol, and at all times after placebo, mean decrements were 25 to 30%. After 18 and 24 h, salmeterol still improved base-line FEV1 relative to placebo, although improvement was not statistically significant at 24 h. Acute symptom increases accompanied FEV1 decrements.
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For all ICSs, the average pharmacy claims per 100 office visits increased from 383 in the year before FSC was introduced to 407 (120 [29.5%] were for FSC and 287 [70.5%] were for single-entity ICSs) in 2003. LABA prescribing increased from 72 in the year before FSC to 147 (120 from FSC, 27 single-entity LABA) in 2003 (p < 0.001). An additional $13,511 per 100 asthma office visits was spent on the FSC product (p < 0.001). After the introduction of FSC, there was no significant difference in asthma admissions (p = 0.17), whereas emergency department (ED) visits increased by 0.92 visits per 100 office visits (p = 0.03). The diagnosis and severity of asthma was inferred from the pharmacy claims and patients with chronic obstructive pulmonary disease could not be excluded. In addition, the study was not designed to assess the impact of other asthma medications on the disease and/or associated costs, and patient adherence to claimed medication could not be monitored.
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Dry powder inhalers are increasingly popular for delivering drugs to the lungs for the treatment of respiratory diseases, but are complex products with multivariate performance determinants. Heuristic product development guided by in vitro aerosol performance testing is a costly and time-consuming process. This study investigated the feasibility of using artificial neural networks (ANNs) to predict fine particle fraction (FPF) based on formulation device variables. Thirty-one ANN architectures were evaluated for their ability to predict experimentally determined FPF for a self-consistent dataset containing salmeterol xinafoate and salbutamol sulfate dry powder inhalers (237 experimental observations). Principal component analysis was used to identify inputs that significantly affected FPF. Orthogonal arrays (OAs) were used to design ANN architectures, optimized using the Taguchi method. The primary OA ANN r(2) values ranged between 0.46 and 0.90 and the secondary OA increased the r(2) values (0.53-0.93). The optimum ANN (9-4-1 architecture, average r(2) 0.92 ± 0.02) included active pharmaceutical ingredient, formulation, and device inputs identified by principal component analysis, which reflected the recognized importance and interdependency of these factors for orally inhaled product performance. The Taguchi method was effective at identifying successful architecture with the potential for development as a useful generic inhaler ANN model, although this would require much larger datasets and more variable inputs.
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A total of 158 children, 6-16 years old, still symptomatic on FP, 100 μg twice a day, during a 4-week run-in period, were included. Percentage of symptom-free days during the last 10 weeks of the treatment period did not differ between treatment groups (per protocol analysis: adjusted mean difference [FP minus SFP] 2.6%; 95% confidence interval, -8.1 to 13.4). Both groups showed substantial improvements of about 25 percent points in symptom-free days (both P < 0.001 from baseline). Lung function measurements (FEV(1), FVC, PEF rate, and maximal expiratory flow) did not differ between groups except for a slight advantage in maximal expiratory flow in the SFP group at 1 week. No differences were found between FP and SFP regarding exacerbation rates, adverse events, or growth.
Step 2 patients were not different from step 3 patients receiving long-acting beta-agonist (LABA). Step 4 patients differed from step 2 by: higher inhaled corticosteroid (ICS) dose (P < .0001); lower forced expiratory volume in 1 second (FEV(1)%; P = .02) and forced mid-expiratory flow (FEF(25-75%); P = .001); higher frequency of resonance (F(res); P = .02) and peripheral airway resistance (R5-R20; P = .006); whereas for steps 3 vs 4 there were differences in F(res) (P < .05) and R5-R20 (P = .006). There were high proportions of abnormality for R5-R20 (>0.03 kPa/L/s) at steps 2, 3, and 4, respectively: 64.6%, 63.5%, and 69.9%. Step 2 patients receiving extra-fine particle ICS demonstrated lower total airway resistance at 5Hz (R5) vs patients receiving standard ICS (124.1% vs 138.3%, P < .05), with no difference in FEV(1). At step 4, R5 remained elevated at 141.3% despite concomitant LABA, with only 2.4% using extra-fine ICS.
To assess the efficacy of ICS and LABA in a single inhaler with mono-component LABA alone in adults with COPD.
GINA guideline recommends stepping down treatment of asthma patients where control is achieved. The aim of this analysis was to estimate the costs and health outcomes associated with step down of controlled patients on high dose fluticasone/salmeterol (FP/S 1000/100 μg daily) to either medium dose FP/S (500/100 μg) dry powder or extrafine beclometasone/formoterol (BDP/F 400/24 μg) pMDI in three European countries.
Significant differences in improvement were found in FEV(1), FVC, IC, distance covered and dyspnea perceived during SWT between the 2 treatments and baseline values (p < 0.05; Friedman's test). However, further analysis showed that only the LABAs + ICS condition showed significant increases in the FEV(1), FVC, IC, DeltaMEF(50%) and distance covered during SWT along with a reduction in maximum isostep exertional dyspnea (p < 0.05; Wilcoxon test). A greater distance was walked at the end of the SWT with LABA + ICS than LABAs alone (301 +/- 105 vs. 270 +/- 112 m; p < 0.05).
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After baseline peak expiratory flow (PEF), salmeterol was administered and serial PEF determined (0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h). Administration of salmeterol MDI plus spacer resulted in significantly greater increases in PEF from baseline vs MDI at 4 h (44 L/min vs 10 L/min; p < 0.01) and 6 h (49 L/min vs 24 L/min; p < 0.05). Both methods of administration were equally well tolerated.