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Fluticasone Improves Pulmonary Function in Children under 2 Years Old with Risk Factors for Asthma.

Teper AM, Kofman CD, Szulman GA, Vidaurreta SM, Maffey AF.

Respiratory Center, Hospital de Ninos Ricardo Gutierrez, Gallo 1330, Buenos Aires, Argentina. ateper intramed.net.

This study assessed the effects of treatment with fluticasone in children younger than 2 years old with recurrent wheezing and risk factors of developing asthma. This double-blind placebo-controlled study randomized children to receive fluticasone (125 mug; n = 14) or placebo (n = 12) twice daily for 6 months. Pulmonary function was assessed at the beginning and end, and parents filled out a daily diary recording respiratory symptoms, need for rescue medication, and emergency care. The SD score of maximum flow at functional residual capacity was -0.74 +/- 0.6 at the beginning and 0.44 +/- 1 at the end for the fluticasone group (p = 0.001), and -0.79 +/- 0.3 at the beginning and -0.78 +/- 1.4 at the end for the placebo group (p = 0.97). A statistically significant difference (p = 0.02) was observed between treatments. The percentage of symptom-free days was 91.3 +/- 7% for fluticasone and 83.9 +/- 10% for placebo (p = 0.05). The number of respiratory exacerbations was 2.1 +/- 1.7 and 4.1 +/- 3 (p = 0.04), and the percentage of days on albuterol was 8.6 +/- 6% and 16.3 +/- 9% (p = 0.028). Treatment with fluticasone twice daily for 6 months improves pulmonary function and clinical outcomes in children with asthma younger than 2 years.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15591466&dopt=Abstract fluticasone Flonase



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Budget impact model for determining the costs of introducing inhaled salmeterol/fluticasone propionate combination for the management of persistent asthma in France.

Detournay B, Pribil C, Jourdanne C, Price M.

Cemka-Eval, Bourg-La-Reine, France.

A budget impact model was used to estimate the effect of introducing inhaled salmeterol/fluticasone propionate combination on asthma drug-related costs in France. The model is based on disease prevalence, drug use, drug acquisition cost and sales forecasting data specific to France. It takes the perspective of social security and has a time horizon of 1 year. All drug acquisition costs are adjusted for the average rate of reimbursement of asthma medications in France (77.3%). All costs are expressed in euros. The model shows that if patients receiving concurrent salmeterol plus fluticasone propionate (or budesonide plus formoterol switch to combined salmeterol/fluticasone propionate, the anticipated annual savings would be 2,691,580 and 1,916,966 euros, respectively. On a fixed budget 4067 additional patients could be treated if salmeterol/fluticasone propionate is substituted for concurrent salmeterol plus fluticasone propionate and an additional 2939 patients if the combination is used to replace concurrent budesonide plus formoterol. Overall, using sales forecasting data to estimate how many patients will switch to the new combination from their current therapy, it is estimated that the introduction of salmeterol/fluticasone propionate will increase the national expenditure in France on asthma medications by a maximum of 3%. This budget impact model shows that the introduction of inhaled salmeterol/fluticasone propionate combination is likely to have minimal impact on asthma-related medication costs in France. Moreover, the available data on the salmeterol/fluticasone propionate combination suggest that it is clinically effective, cost-effective and affordable to the French healthcare system.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15609139&dopt=Abstract fluticasone Flonase



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Effect of fluticasone propionate and salmeterol in a single device, fluticasone propionate, and montelukast on overall asthma control, exacerbations, and costs.

O'Connor RD, Stanford R, Crim C, Yancey SW, Edwards L, Rickard KA, Dorinsky P.

Sharp Rees-Stealy Medical Group, San Diego, California 92101, USA. Richard.oconnor sharp.com

BACKGROUND: Inhaled corticosteroids are the most effective class of anti-inflammatory agents and are recommended for patients with persistent asthma. OBJECTIVE: To compare the effectiveness of (1) fluticasone propionate, 100 microg, and salmeterol, 50 microg; (2) fluticasone propionate, 100 microg; and (3) montelukast, 10 mg, as first-line maintenance treatment for persistent asthma. METHODS: Combined analysis of 4 clinical trials, 2 that compared fluticasone propionate-salmeterol with montelukast and 2 that compared fluticasone propionate with montelukast as initial asthma therapy. RESULTS: The 4 studies had a total of 1,910 patients 15 years or older with symptomatic asthma previously treated with inhaled short-acting beta2-agonists alone. At the end point, there were significantly greater increases in forced expiratory volume in 1 second with fluticasone propionate-salmeterol (0.57 L; P < or = .004) vs fluticasone propionate (0.48 L) and montelukast (0.31 L) and significantly greater increases in morning peak expiratory flow rate (84.9 L/min; P < .001) vs fluticasone propionate (56.0 L/min) and montelukast (36.1 L/min). Fluticasone propionate-salmeterol significantly increased the percentage of symptom- and rescue-free days and significantly reduced albuterol use vs fluticasone propionate and montelukast (P < or = .04 for both). Patients treated with fluticasone propionate and montelukast had 2.6 and 3.6 greater risk, respectively, of having an asthma-related exacerbation vs fluticasone propionate-salmeterol users. In addition, mean daily exacerbation costs per treated patient were dollars 0.41 for fluticasone propionate-salmeterol, dollars 4.60 for fluticasone propionate, and dollars 7.57 for montelukast, whereas mean daily costs per patient exacerbation for fluticasone propionate-salmeterol, fluticasone propionate, and montelukast were dollars 29, dollars 128, and dollars 154, respectively. CONCLUSIONS: Patients with symptomatic asthma previously treated with short-acting beta2-agonists only who require maintenance therapy are likely to have greater clinical benefits, lower risk of an asthma exacerbation, and reduced exacerbation-related costs when initiating therapy with fluticasone propionate-salmeterol vs fluticasone propionate or montelukast.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15609769&dopt=Abstract fluticasone Flonase



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Changes in prescribing of inhaled corticosteroids (1999-2002) in Scotland.

Boyter AC, Steinke DT.

Department of Pharmaceutical Sciences, University of Strathclyde, John Arbuthnott Building, Glasgow, Scotland, UK.

PURPOSE: To investigate the trend in prescribing of inhaled corticosteroids and general practitioner (GP) consultations for respiratory diseases. METHODS: A longitudinal observation study of all prescriptions, from primary care, for inhaled corticosteroids dispensed in Scotland from January 1999 to May 2002 was undertaken.The main outcome measures were the trends in prescribing of inhaled corticosteroids and GP consultations for respiratory diseases. RESULTS AND CONCLUSIONS: The prescribing of all inhaled corticosteroids has risen over the study period. The rise in prescribing of the combination product containing fluticasone and salmeterol appears not to have been at the expense of the prescribing of fluticasone alone while the prescribing of the budesonide/eformoterol combination may be at the expense of budesonide (BUD) alone. GP consultations for both asthma and chronic obstructive pulmonary disease (COPD) have declined over a similar period.The increased prescribing of inhaled corticosteroids over this period is associated with the increased use of the fluticasone/salmeterol combination rather than an increase in the use of all inhaled corticosteroids. The accompanying fall in number of consultations with GPs may be due to this increased prescribing or a move to nurse led clinics. Copyright (c) 2004 John Wiley & Sons, Ltd.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15624197&dopt=Abstract fluticasone Flonase



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[The effect of inhaled glucocorticosteroid on protein kinase Calpha expression and interleukin-5 production in induced sputum inflammatory cells of asthma patients.]

[Article in Chinese]

Tang YJ, Xu YJ, Xiong SD, Zhao JP, Zhang ZX.

Department of Respiratory Disease, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China.

OBJECTIVE: To investigate the expression of protein kinase Calpha (PKCalpha) in inflammatory cells and the level of interleukin-5 (IL-5) in induced sputum in asthma patients and the effect of inhaled glucocorticosteroid on them. METHODS: 29 asthma patients were classified into 2 groups; 14 patients were treated with fluticasone propionate for 2 weeks and the others were treated with fluticasone propionate for 4 weeks. Induced sputum with inhaled hypertonic saline (4% - 5%) was collected. 13 healthy volunteers were included as controls. Lung ventilatory function and forced expiratory volume in one second (FEV(1)) were measured in all patients. The expression of PKCalpha in the inflammatory cells was detected using immunocytochemistry and the positive percentage in different cells was counted. IL-5 in sputum supernatants was detected using enzyme-linked immunosorbent assay. RESULTS: The percentage of eosinophils (11.1 +/- 4.3)%, lymphocytes (4.3 +/- 2.6)%, PKCalpha positive cells (79.0 +/- 9.6)% and the concentration of IL-5 (64.9 +/- 46.0) ng/L in asthmatics were higher than the percentage of eosinophils (0.7 +/- 0.5)%, lymphocytes (1.1 +/- 0.5)%, PKCalphapositive cells (10.5 +/- 2.3)% and the concentration of IL-5 (14.3 +/- 8.4) ng/L in the controls (P < 0.01). The percentage of PKCalpha positive cells and the concentration of IL-5 in the two groups of asthma were lower than that before fluticasone propionate treatment (P < 0.05), and the forced expiratory volume in first second was correlated to them (respectively, r = -0.423, P < 0.05; n = 29, r = -0.664, P < 0.01). The concentration of IL-5 was correlated to the percentage of PKCalpha positive cells (n = 29, r = 0.623, P < 0.01). CONCLUSIONS: PKCalpha in the inflammatory cells and IL-5 may play an important part in airway inflammation, and the signal transduction of the PKCalpha may be one of the mechanisms of the airway inflammation in asthma. Glucocorticosteroid could suppress the expression of PKCalpha in airway inflammatory cells and then decrease the production of IL-5 in asthmatic airways.

Online source: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15634547&dopt=Abstract fluticasone Flonase