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To examine the efficacy of long-acting beta 2-agonists and their role in primary care asthma management and to review briefly the pharmacology of these agents.
Particle size distributions for the Optichamber, various sizes of Aerochamber, and the Aerochamber Plus were very similar and the particle size distributions for all VHCs were similar to the distribution of the control. The FPM for particles ranging from 0.7 to <3.3 microm in diameter (in the range shown to provide the greatest lung dose to negotiate the small airways of infants) was similar across the various VHCs tested. Statistical comparison of the fine particle fraction for these stages shows a very similar profile when differences from the salmeterol MDI control were evaluated.
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FSC is associated with a lower risk of COPD-related exacerbation events relative to ATC in managed-care Medicare beneficiaries with COPD. Findings from this study are only generalizable to managed-care Medicare beneficiaries residing in the community.
This paper reports an LC/MS/MS method for analysis of salemeterol and fluticasone propionate in human plasma based on combined SPE-based extraction and separate LC/MS/MS conditions. Previously reported interaction between analytes was confirmed and eliminated by their separation in the sample preparation step to ensure no negative impact on their quantitation. The method was validated per FDA guidelines in the range of 2.5-500 pg/mL for salmeterol and 5-500 pg/mL for fluticasone propionate. The method is suitable for plasma analysis of combined salmeterol/fluticasone formulation without adverse effects of inter-analyte interactions on quantitation.
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COPD is a disease with a multi-component pathophysiology in which inflammation plays a key role. An anti-inflammatory effect of salmeterol (S)/fluticasone propionate (FP) combination (SFC), as demonstrated in a number of biopsy studies, may be the mechanism by which it provides a potential survival benefit in COPD patients in the TORCH study. It is possible that the molecular synergy between S and FP shown in COPD results in enhanced anti-inflammatory in the airways. This may also contribute to the reduction in exacerbations and the increase in lung function seen in the TORCH study. Alternatively, SFC may prolong survival by impacting on systemic inflammation and disease co-morbidities in COPD.
The primary goal of this study was to determine whether there is a correlation between changes in asthma symptoms during treatment and changes in lung function, as measured by peak expiratory flow (PEF). A secondary goal was to compare the relative efficacy (in terms of improvement in asthma symptoms and lung function) of 3 commonly used asthma treatments: inhaled fluticasone propionate, inhaled salmeterol xinafoate, and oral zafirlukast.
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Indacaterol 150 μg resulted in a higher change from baseline (CFB) in FEV(1) at 12 weeks compared to FOR/BUD 9/160 μg (difference in CFB 0.11 L [95% credible intervals: 0.08, 0.13]) and FOR/BUD 9/320 μg (0.09 L [0.06, 0.11]) and was comparable to SAL/FP 50/250 μg (0.02 L [-0.04, 0.08]) and SAL/FP 50/500 μg (0.03 L [0.00, 0.06]). Similar results were observed for indacaterol 300 μg at 12 weeks and indacaterol 150/300 μg at 6 months. Indacaterol 150 μg demonstrated comparable improvement in SGRQ total score at 6 months versus FOR/BUD (both doses), and SAL/FP 50/500 μg (-2.16 point improvement [-4.96, 0.95]). Indacaterol 150 and 300 μg demonstrated comparable TDI scores versus SAL/FP 50/250 μg (0.21 points (-0.57, 0.99); 0.39 [-0.39, 1.17], respectively) and SAL/FP 50/500 μg at 6 months.
On average, the 59 patients completing the study (mean age ± SD 51 ± 12 years, 38 women) had significant improvement in VAS and QLQ scores at the end of the treatment period (49.1 ± 2.4 vs. 73.1 ± 2.05 and 146.1 ± 2.7 vs. 176.7.1 ± 3.4 respectively, P < 0.001), but not in the inflammatory indicators (EBT, CRP and Eos). However, when comparing the "top responders" with the "poor responders", significant improvement in these inflammatory indicators was observed: EBT significantly decreased from 34.04/mean/± 0.30/s.e.m./[°C] to 33.57 ± 0.33, P = 0.003, Eos in blood fell from 381.7 ± 91.2 [cells/μL] to 244.2 ± 43.2, P = 0.02. Before/after treatment differences in hsCRP decreased significantly in the top responders compared with the poor responders (Mann-Whitney test, P = 0.04).
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In order to assess whether the administration of salmeterol/fluticasone propionate combination (50/250 mcg by Diskus) for 1 week induces tolerance to the bronchoprotective effect of salmeterol on allergen challenge, a single-blind, cross-over study was carried out. We studied nine subjects (eight men and one woman; mean age+/-SD: 31.3+/-11.0 yr) with mild intermittent allergic asthma, never treated with regular beta2-agonists or inhaled corticosteroids. In a previous allergen challenge all subjects had shown a positive early airway response (EAR) to allergen. They underwent allergen challenge after 1-week treatment with placebo and a single dose of placebo immediately before allergen challenge (T1), or 1-week treatment with placebo and a single dose of salmeterol/fluticasone immediately before allergen challenge (T2), or 1-week treatment with salmeterol/fluticasone combination bid and a single dose of salmeterol/fluticasone immediately before allergen challenge (T3). EAR was evaluated both as maximum decrease in FEV1 (MaxDeltaFEV1 %) after allergen challenge and as area under FEV1 -time curve. MaxDeltaFEV1 % during allergen challenge protected by placebo (T1) was significantly greater than MaxDeltaFEV1 % during allergen challenges protected by single dose of salmeterol/fluticasone (T2) and by salmeterol/fluticasone 1-week treatment (T3). No difference was found in MaxDeltaFEV1 % between T2 and T3. The same results were observed also after computing the area under the curve for each challenge. When individually considered, all subjects were protected against EAR (protection index > or = 80%) at T2, while at 3 seven out of nine subjects were still protected against EAR. In conclusion, the simultaneous administration of salmeterol and fluticasone in the same device prevents in almost 80% of examined subjects the development of tolerance to the protective effect of salmeterol on allergen challenge. This observation may contribute to explain the positive interaction between inhaled beta2-agonists and corticosteroids in the long-term treatment of asthma.
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Treatment were changed to SFC in one hundred and three patients with mild to severe asthma receiving concurrent administration of salmeterol and FP with separate Diskus. Asthma control test (ACT), easy asthma program (EAP) and peak expiratory flow (PEF) were performed before and after 2 or 4 weeks of SFC treatment.
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Asthma is now considered as an inflammatory condition and the purpose of the treatment is directed towards the control of inflammation. Recent therapeutic guidelines have been proposed and suggested the early use of antiinflammatory preparations. Salmeterol has a prolonged bronchodilator and protective effect against physical stimuli such as exercise and exposure to cold air. Clinical studies have all shown a superiority of salmeterol by comparison with salbutamol in the treatment of asthma. Recent in vitro and in vivo studies also suggest that salmeterol may have an extra non-bronchodilator effect. Salmeterol appears to be a safe preparation if administered at a dose of 50 to 100 micrograms on a BID regimen. It has been argued that the regular use of salmeterol can mask the worsening of bronchial inflammation although clinical studies have not substantiated this potential risk. Other studies are required to answer this question. A scheme incorporating salmeterol in the guidelines for the treatment of asthma is proposed.
A retrospective cohort study assessed COPD-related outcomes using administrative claims data among ICS/LABA-naïve patients. Patients initiating BFC were propensity matched to FSC patients. Cost and effectiveness were measured as total healthcare expenditures, exacerbation events (hospitalizations, emergency department visits, or outpatient visits associated with oral corticosteroid or antibiotic prescription fills), and treatment medication adherence. Differences in COPD symptom control were assessed via proxy measure through claims for rescue medications and outpatient encounters.
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The effect of a single dose of salmeterol, long-term, regular treatment with salmeterol and a termination of the therapy on specific and non-specific bronchial reactivity were evaluated. The effect of the therapy on serum ECP level was studied too. The studies were carried out in a group of 16 mild asthmatics sensitive to mite allergens. Both types of bronchial challenges were performed according to Ryan's method. Blood samples to evaluate the ECP level were collected before treatment and on the day before the last day of the study. The single dose of 50 micrograms of salmeterol taken 3 hours before bronchial challenge significantly decreased the bronchial response to histamine (the average PC20FEV1 value increased about a four fold after salmeterol) and to the Dpt allergen (PD20FEV1 increased 3.5 fold). No effect of salmeterol on LAR was observed. Bronchial reactivity to histamine was significantly lower in the period of the therapy and did not differ from the baseline 12 hours after stopping the treatment. PD20FEV1 Dpt during the therapy was about 3 fold higher than the baseline but 36 hours after stopping the treatment did not differ from the baseline. Although the patients had inhaled a 3-fold higher dose of allergen to induce EAR, the frequency of LAR did not change. No anti-inflammatory effect of salmeterol was observed.
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This was a randomized, double-blind, double-dummy, two-way crossover, multicenter study. Following a run-in period, 28 patients with severe COPD (mean age 65 years, mean forced expiratory volume in 1 second [FEV1] 37.5% predicted normal) and 27 healthy subjects (mean age 31 years, FEV1 103.3% predicted normal) received two single-dose treatments of budesonide/formoterol (400/12 microg) and salmeterol/fluticasone (50/500 microg), separated by a 4-14-day washout period. ICS concentrations were measured over 10 hours post-inhalation in plasma in all subjects, and over 6 hours in spontaneously expectorated sputum in COPD patients. The primary end point was the area under the curve (AUC) of budesonide and fluticasone plasma concentrations in COPD patients relative to healthy subjects.
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Mean improvement in AQLQ scores achieved clinical importance in all four domains in the salmeterol/fluticasone group (AQLQ change > or =0.5), but in only two domains in the budesonide group. Although the mean overall improvement in AQLQ scores observed in the salmeterol/fluticasone group was significantly greater than that observed in the budesonide group (difference of 0.45; p = 0.002), the difference was less than the minimal important difference (0.5). Nevertheless, further analysis showed that the number-needed-to-treat was only 3.4. This indicates that only 3.4 patients need to be treated with the salmeterol/fluticasone combination for one patient to experience a meaningful improvement in HR-QOL, relative to monotherapy with an increased dose of budesonide.
Airway smooth muscle hypertrophy appears to be present in severe asthma. However, the effect of corticosteroids on airway smooth muscle cell size or contractile protein expression has not been studied. We examined the effects of dexamethasone, fluticasone, and salmeterol on contractile protein expression in transforming growth factor (TGF)-beta-treated primary bronchial smooth muscle cells. Dexamethasone and fluticasone, but not salmeterol, each reduced expression of alpha-smooth muscle actin and the short isoform of myosin light chain kinase. Steady-state alpha-actin mRNA level and stability were unchanged, consistent with posttranscriptional control. Fluticasone significantly decreased alpha-actin protein synthesis following treatment with the transcriptional inhibitor actinomycin D, indicative of an inhibitory effect on mRNA translation. Fluticasone also significantly increased alpha-actin protein turnover. Finally, fluticasone reduced TGF-beta-induced incorporation of alpha-actin into filamentous actin, cell length, and cell shortening in response to ACh and KCl. We conclude that glucocorticoids reduce human airway smooth muscle alpha-smooth muscle actin expression and incorporation into contractile filaments, as well as contractile function, in part by attenuation of mRNA translation and enhancement of protein degradation.
Recommended treatment for moderate to severe asthma is the combination of an inhaled corticosteroid and a long-acting beta(2)-agonist. The present study was designed to compare a new fixed combination of extrafine beclomethasone and formoterol, with the fixed combination fluticasone and salmeterol.
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Current metered dose inhalers (MDIs) contain chlorofluorocarbon (CFC) propellants. A new propellant HFA134a, with no effect on ozone, may be a suitable alternative. Four asthma medications, salbutamol, salmeterol, fluticasone propionate (FP) and beclomethasone dipropionate (BDP), currently containing standard CFC propellants, were formulated with HFA134a for investigation. Single doses of salbutamol (200 micrograms) and salmeterol (50 micrograms, 100 micrograms) provided equivalent protection against bronchial provocation, after histamine and methacholine respectively, compared with the current preparation. A double-blind 4 week study comparing the two formulations of salbutamol, used as required in mild to moderate asthma, showed similar effects on morning peak expiratory flow rates (PEFR) and inhaler use. Salmeterol (50 micrograms) twice daily was compared with the current formulation in a 4 week trial. Improvement in morning PEFR was similar for both formulations. A double-blind study compared the two formulations of FP (250 micrograms) twice daily in moderate asthmatics previously taking 400-1,000 micrograms of inhaled corticosteroid daily. Morning PEFR improved in both groups. Safety and tolerability of the HFA134a product were similar to current formulations. The HFA134a formulations of salbutamol, salmeterol and FP provide equivalent efficacy with a similar safety profile to the existing formulations at equivalent doses.
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To test the hypotheses that fluticasone inhibits BHR after either allergen sensitization or IL-13 administration and that fluticasone restores the bronchodilation and bronchoprotective effects of beta-agonists.
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Measurements were performed in bronchoalveolar lavage fluid obtained 6 hrs postchallenge. Inhalation of LPS enhanced pulmonary coagulation as determined by an increase in the concentrations of thrombin-antithrombin complexes, factor VIIa, and soluble tissue factor in bronchoalveolar lavage fluid (all p < .05 vs. saline). LPS concurrently inhibited pulmonary fibrinolysis, as reflected by a decrease in bronchoalveolar lavage fluid plasminogen activator activity together with an increase in plasminogen activator inhibitor type 1 (both p < .05 vs. saline). Moreover, LPS inhalation was associated with a suppression of the anticoagulant protein C pathway, as indicated by an increase in soluble thrombomodulin and decreases in protein C and activated protein C levels in bronchoalveolar lavage fluid (all p < .05 vs. saline). Salmeterol, either with or without LPS inhalation, enhanced fibrinolysis (plasminogen activator activity and tissue-type and urokinase-type plasminogen activator levels) but did not influence LPS-induced changes in coagulation or the protein C pathway.
No significant differences in FEV 1 were found between treatments at any time point. PD20 significantly increased after the first dose of salmeterol was given (geometric mean, 100 micro g). Geometric mean PD20 values were significantly better during salmeterol treatment than during salbutamol treatment, 52 and 25 micro g, respectively (p = 0.005).
Patients with COPD represent a heterogeneous population in terms of their reporting of symptoms and response to treatment. GMM analyses are able to identify sub-groups of responders and non-responders. Application of this methodology could be of value on other endpoints in COPD and in other disease areas.
Double-blind, randomized, placebo-controlled study.
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The breath-actuated SB device was comparable to 'out of the box' small and large volume spacers and produced similar improvements in relative systemic lung bioavailability for fluticasone and salmeterol.
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Four hundred eleven symptomatic patients with COPD with FEV1 < or = 65% predicted and no clinically significant concurrent disease.