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Fluticasone and Salmeterol Oral Inhalation. The combination of fluticasone and salmeterol Advair Diskus Previous systemic beta 2 agonists such as procatrol tablets and tulobuterol patch were developed in Japan to address nocturnal symptoms and maintenance of lung function in asthmatic patients.

Salmeterol , a potent and highly selective in beta 2 adrenocepter agonist with a duration of action greater than 12 h, was developed to provide long duration of bronchodilation with binding to a non-active site in the beta 2 -adrenocepter.

Salmeterol is administrated via dry power inhalation and clinical studies have showed it has a good efficacy and a good safety profile, similar to inhaled steroids.

Indeed, many clinical studies showed that salmeterol demonstrated better efficacy than long-acting beta 2 -agonist oral bronchodilators, theophyllines, and leukotriene-receptor antagonists in asthmatic patients and anticholinergic agents and theophyllines in COPD patients.

The safe and appropriate use of long-acting beta-agonists LABAs for the treatment of asthma has been widely debated. In two large clinical trials, investigators found a potential risk of serious asthma-related events associated with LABAs. This study was designed to evaluate the risk of administering the LABA salmeterol in combination with an inhaled glucocorticoid, fluticasone propionate. All the patients had a history of a severe asthma exacerbation in the year before randomization but not during the previous month.

Patients were excluded from the trial if they had a history of life-threatening or unstable asthma. The primary safety end point was the first serious asthma-related event death, endotracheal intubation, or hospitalization.

The efficacy end point was the first severe asthma exacerbation. Of 11, patients who were enrolled, 67 had 74 serious asthma-related events, with 36 events in 34 patients in the fluticasone- salmeterol group and 38 events in 33 patients in the fluticasone-only group. The hazard ratio for a serious asthma-related event in the fluticasone- salmeterol group was 1. There were no asthma-related deaths; 2 patients in the fluticasone-only group underwent asthma-related intubation.

The effects of salmeterol on power output in nonasthmatic athletes. Salmeterol xinafoate is a new aerosol inhalant that is used in the treatment of asthma. It is currently banned by the International Olympic Committee because of the concern that it may lend an unfair competitive advantage to the user. The purpose of this study was to determine whether salmeterol improves short-term anaerobic performance in elite nonasthmatic track cyclists.

Eleven elite track cyclists volunteered to perform a second all-out cycle ergometer test 3 hours after receiving either 42 micrograms of salmeterol xinafoate or placebo applied in a double-blind crossover procedure. During the ergometer test, peak power output, total work, time to peak power, and percent fatigue decline in power output were measured. Pulmonary measurements were also taken before and at various time points after inhalation and the ergometer test.

A methacholine challenge was administered to each subject before participation in the study to ensure that none of the subjects had any reactive airway diseases. No differences between trials were observed for the pulmonary function test variables at any of the time points. Blood lactate concentrations before and after administration of drug or placebo were also not significantly different between trials. Additionally, salmeterol did not affect the maximal heart rate achieved during the test as compared with the placebo.

Short-term salmeterol use within the prescribed dosage was not shown to increase short-term power output in nonasthmatic cyclists. Tiotropium versus salmeterol for the prevention of exacerbations of COPD.

A total of patients were randomly assigned to and treated with tiotropium patients or salmeterol patients. Tiotropium, as compared with salmeterol , increased the time to the first exacerbation days vs. These results show that, in patients with moderate-to-very-severe COPD, tiotropium is more effective than salmeterol in preventing exacerbations. Salmeterol improves fluid clearance from alveolar-capillary membrane in COPD patients: a pilot study.

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. In the control setting with no infusion, we found no significant change in either DLCO or mechanical properties of the lung.

Salmeterol appears to provide a protective effect, not related to bronchodilation, against an acute alveolar fluid clearance challenge secondary to lung fluid overload in COPD patients.

All rights reserved. Salmeterol inhaler using a non-chlorinated propellant, HFAa: systemic pharmacodynamic activity in healthy volunteers. PubMed Central. These face an international ban due to their effect on the ozone layer. Salmeterol has been reformulated using the non-chlorinated propellant Glaxo inhalation grade HFAa.

RESULTS--Safety and tolerability were similar and the response was related to the dose over the range used micrograms with both salmeterol inhalers. Safety of regular formoterol or salmeterol in children with asthma: an overview of Cochrane reviews. Background Two large surveillance studies in adults with asthma have found an increased risk of asthma-related mortality in those who took regular salmeterol as monotherapy in comparison to placebo or regular salbutamol. No similar sized surveillance studies have been carried out in children with asthma, and we remain uncertain about the comparative safety of regular combination therapy with either formoterol or salmeterol in children with asthma.

Objectives We have used the paediatric trial results from Cochrane systematic reviews to assess the safety of regular formoterol or salmeterol , either as monotherapy or as combination therapy, in children with asthma. Methods We included Cochrane reviews relating to the safety of regular formoterol and salmeterol from a search of the Cochrane Database of Systematic Reviews conducted in May , and ran updated searches for each of the reviews.

These were independently assessed. We extracted the data relating to children from each review and from new trials found in the updated searches including risks of bias, study characteristics, serious adverse event outcomes, and control arm event rates.

The safety of regular formoterol and salmeterol were assessed directly from the paediatric trials in the Cochrane reviews of monotherapy and combination therapy with each product. Then monotherapy was indirectly compared to combination therapy by looking at the differences between the pooled trial results for monotherapy and the pooled results for combination therapy. The comparative safety of formoterol and salmeterol was assessed using direct evidence from trials that randomised children to each treatment; this was combined with the result of an indirect comparison of the combination therapy trials, which represents the difference between the pooled results of each product when randomised against inhaled corticosteroids alone.

Main results We identified six high. Particle interactions of fluticasone propionate and salmeterol xinafoate detected with single particle aerosol mass spectrometry SPAMS. Particle co-associations between the active pharmaceutical ingredients fluticasone propionate and salmeterol xinafoate were examined in dry powder inhaled DPI and metered dose inhaled MDI combination products.

A simple rules tree was used to identify each compound, either alone or co-associated at the level of the individual particle, using unique marker peaks in the mass spectra for the identification of each drug. The majority of the detected salmeterol particles were found to be in co-association with fluticasone in both tested devices.

Another significant finding was that rather coarse fluticasone particles in DPI and fine salmeterol particles both MDI and DPI were forming the particle co-associations.

Long-acting beta-agonists LABAs have been shown to increase the risk of asthma-related death among adults and the risk of asthma-related hospitalization among children. It is unknown whether the concomitant use of inhaled glucocorticoids with LABAs mitigates those risks.

This trial prospectively evaluated the safety of the LABA salmeterol , added to fluticasone propionate, in a fixed-dose combination in children. We randomly assigned, in a ratio, children 4 to 11 years of age who required daily asthma medications and had a history of asthma exacerbations in the previous year to receive fluticasone propionate plus salmeterol or fluticasone alone for 26 weeks. The primary safety end point was the first serious asthma-related event death, endotracheal intubation, or hospitalization , as assessed in a time-to-event analysis.

The main efficacy end point was the first severe asthma exacerbation that led to treatment with systemic glucocorticoids, as assessed in a time-to-event analysis. Among the patients, 27 patients in the fluticasone- salmeterol group and 21 in the fluticasone-alone group had a serious asthma-related event all were hospitalizations ; the hazard ratio with fluticasone- salmeterol versus fluticasone alone was 1.

A total of patients 8. In this trial involving children with asthma, salmeterol in a fixed-dose combination with fluticasone was associated with the risk of a serious asthma-related event that was similar to the risk with fluticasone alone.

Funded by Glaxo. Regular treatment with formoterol versus regular treatment with salmeterol for chronic asthma: serious adverse events.

Background An increase in serious adverse events with both regular formoterol and regular salmeterol in chronic asthma has been demonstrated in previous Cochrane reviews. Objectives We set out to compare the risks of mortality and non-fatal serious adverse events in trials which have randomised patients with chronic asthma to regular formoterol versus regular salmeterol.

The date of the most recent search was January Data collection and analysis Two authors independently selected trials for inclusion in the review and extracted outcome data. We sought unpublished data on mortality and serious adverse events from the sponsors and authors. Main results The review included four studies involving adults and children. All studies were open label and recruited patients who were already taking inhaled corticosteroids for their asthma, and all studies contributed data on serious adverse events.

There was only one death in an adult which was unrelated to asthma and none in children, and there were no significant differences in non-fatal serious adverse events comparing formoterol to salmeterol in adults Peto odds ratio OR 0.

This has resulted in heightened scrutiny of LABAs and comprehensive reviews by regulatory agencies. The aim of this retrospective observational cohort study was to better characterize salmeterol medication use patterns in the UK. Prescriptions patterns by medication class, including concurrent prescription of salmeterol with inhaled corticosteroids ICS , were described using 6-month intervals in the 1-year period before and after the salmeterol -containing index prescription.

In the 12 months following initiation of the salmeterol -containing prescription, a decrease in asthma prescriptions was observed. These results support the appropriate prescribing of salmeterol -containing medications, as per recommendations in asthma treatment guidelines in the UK.

Salmeterol was consistently prescribed as an add-on asthma-controller with an ICS for most patients, and was associated with improvements in asthma control, as indicated by decreases in SABA and systemic corticosteroid prescriptions following salmeterol introduction. Suppressive effects of formoterol and salmeterol on eotaxin-1 in bronchial epithelial cells. 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. Effects of formoterol and salmeterol on nuclear and cytosolic pSTAT-6 expression were evaluated by Western blot and immunofluorescence study. A specific beta 2 adrenoceptor antagonist ICI , 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 m.

The western blot and immunofluorescence studies demonstrated that formoterol 10 -7 m suppressed the nuclear expression of pSTAT Formoterol and salmeterol , two inhaled long-acting beta 2 agonists, down-regulated IL 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. A pharmacoeconomic review of its use in the management of asthma. A large proportion of asthma-related costs are attributable to poor asthma control. Treatment strategies which improve clinical outcomes in patients with asthma, therefore, have the potential for significant economic benefits, and it is important to evaluate new asthma therapies for cost effectiveness.

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