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Miscellaneous

Fluticasone propionate: a potent inhaled corticosteroid for the treatment of asthma

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Pages 1227-1244 | Published online: 24 Feb 2005

Bibliography

  • NATIONAL ASTHMA EDUCATION AND PREVENTION PROGRAM. Expert Panel Report II: Guidelines for the diagnoses and management of asthma. Bethesda, MD, USA: National Heart, Lung, and Blood Institute, US Dept of Health and Human Services; 1997.
  • •A review of the asthma management expert panel guidelines for the United States.
  • HOLLIDAY SM, FAULDS D, SORKIN EM: Inhaled flutica- sone propionate: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in asthma. Drugs (1994) 47(2):318–331.
  • •A review of the use of FP as an inhaled preparation in the treatment of asthma.
  • KELLY HW: Establishing a therapeutic index for the inhaled corticosteroids: part I. pharmacoki-netic/pharmacodynamic comparison of the inhaled corticosteroids. J. Allergy Clin. Immunol. (1998) 102:S36–S51.
  • •A thorough review of the pharmacokinetic and pharmaco-dynamic differences of the inhaled corticosteroids and their translation into clinical efficacy.
  • SORKNESS CA: Establishing a therapeutic index for the inhaled corticosteroids: part II. Comparison of systemic activity and safety among different inhaled corticosteroids. J. Allergy Clin. Immunol. (1998) 102:S.
  • •A thorough review of the systemic activity of ICS and their clinical implications.
  • BARNES PJ: Mechanisms of action of glucocorticoids in asthma. Am. J. Respir. Grit. Care Med. (1996) 154:S21–27.
  • •A thorough review of GC pharmacology.
  • OLIVIERI D, CHETTA A, DONNO MD et al.: Effect of short-term treatment with low-dose inhaled flutica-sone propionate on airway inflammation and remodelling in mild asthma: a placebo-controlled study. Am. J. Respir. Grit. Care Med. (1997) 155:1864–1871.
  • •A study investigating the anti-inflammatory activity of FP by evaluating cells in bronchoalveolar lavage fluid.
  • Research Triangle Park, NC, USA, GlaxoWellcome Ltd.: Inhaled fluticasone propionate inhalation powder. (1998).
  • PIETERS WR, STALLAERT RALM, PRINS J et al.: A study on the clinical equivalence and patient preference of fluticasone propionate 2501g twice daily via the diskus/accuhaler inhaler or the diskhaler inhaler in adult asthmatic p atients.J. Asthma (1998) 35(4)337–345.
  • •A well designed trial comparing the two delivery devices available for FP.
  • PEDEN DB, BERGER WE, NOONAN MJ et al.: Inhaled fluticasone propionate delivered by means of two different multidose powder inhalers is effective and safe in large pediatric population with persistent asthma. J. Allergy Clin. Immunol. (1998) 102:32–38.
  • •A 12 week study evaluating the effectiveness of the Diskus and Diskhaler in a paediatric population.
  • PRIME D, PARKES PA, PETCHEY L, SLATER AL, WOODHOUSE RN: Evaluation of the pharmaceutical performance of two dry powder inhalers: comparison of the diskus and turbuhaler inhalers. Am]. Respir. Grit. Care Med. (1998) 1 53 (4) Pt. 2 of 2:A62.
  • •An abstract comparing the dose delivered at varying inspira-tory flow rates between the Diskus and Turbuhaler devices.
  • WILLIAMS J, RICHARDS KA: Ease of handling and clinical efficacy of fluticasone propionate accuhaler/diskus inhaler compared with turbuhaler inhaler in pediatric patients. Br. J Clin. Pract. (1997) 51 (3):147–153.
  • •A prospective trial comparing patient ability to handle and effectively administer doses of FP and BUD by their respec-tive DPI devices.
  • MILGROM H, BENDER B, ACKERSON L et al.: Non-compliance and treatment failure in children with asthma. J. Allergy Clin. Immunol. (1996) 98(6 pt. 1):409–413.
  • •A report of the association between medication non-adherence and exacerbations of asthma.
  • COCHRANE MG, BALA MV, DOWNS KE, MAUSKAUF J, BEN-JOSEPH RH: Inhaled corticosteroids for asthma therapy: patient compliance, devices, and inhalation technique. Chest (2000) 1 1 7:524–550.
  • •A meta-analysis evaluating factors influencing patient adherence to ICS therapy for asthma.
  • THORSSON L, DAHLSTROM K, EDSBACKER S, et al.: Pharmacokinetics and systemic effects of inhaled fluticasone propionate in healthy subjects. Br. J Clin. Pharmcol. (1997) 43:155–61.
  • •A study that determined some pharmacokinetic variables for FP.
  • LAWRENCE M, WOLFE J, WEBB R et al.: Efficacy of inhaled fluticasone propionate in asthma results from topical and not from systemic activity. Am. J Respir. Crit. Care Med. (1997) 156:744–751.
  • •A study determining that activity of FP arises from topical activity, administered by inhalation of drug, rather than from systemic activity.
  • MACKIE AE, VENTRESCA GP, FULLER RW et al.: Pharma- cokinetics of intravenous fluticasone propionate in healthy subjects. J. Clin. Pharmacol. (1996) 41:539–542.
  • •A study determining the pharmacokinetic parameters of FP. Exp. Opin. Pharmacother. (2000) 1(6)
  • MACKENZIE CA, WEINBERG EG, TABACHNIK E, TAYLOR M, HAVNEN J, CRESCENZI K: A placebo-controlled trial of fluticasone propionate in asthmatic children. Eur. Pediatr. (1993) 152:856–860.
  • •A prospective study evaluating FP delivered by Diskhaler to children aged 6–14 years of age.
  • BISGAARD H, GILLIES J, GROENEWALD M, MADEN C: The effect of inhaled fluticasone propionate in the treatment of young asthmatic children. Am. J Respir. Grit. Care Med. (1999) 160:126–131.
  • •A Danish study evaluating FP delivered by MDI in children (mean age of 28 months) with asthma.
  • HOEKSTRA MO, GROL MH, BOUMAN K eta].: Fluticasone propionate in children with moderate asthma. Am. J Respir. Grit. Care Med. (1996) 154:1039–1044.
  • •A study evaluating the effects of FP delivered by the Diskhaler in children aged 8–14 years.
  • BARNES NC, MARONE G, MARIA GU, VISSER S, UTAMA I, PAYNE SL: A comparison of fluticasone propionate, 1mg daily, with beclomethasone dipropionate, 2mg daily, in the treatment of severe asthma. Eur. Respir. (1993) 6:877–884.
  • •A 6 week study comparing pharmacodynamically equiva-lent doses of FP and BDP in patients with severe asthma.
  • WASSERMAN SI, GROSS GN, SCHOENWETTER WF et al.: A 12-week dose-ranging study of fluticasone propionate powder in the treatment of asthma. J Asthma (1996) 33 (4):265–274.
  • •A placebo-controlled trial of 3 different doses of FP delivered by the Diskhaler.
  • CHERVINSKY P, VAN AS A, BRONSKY EA et al: Flutica- sone propionate aerosol for the treatment of adults with mild to moderate asthma. J. Allergy Clin. Immunol. (1994) 94:676–683.
  • •A study evaluating FP delivered by aerosol in the treatment of mild to moderate asthma.
  • RAPHAEL GD, LANIER RO, BAKER J, EDWARDS L, RICKARD K, LINCOURT WR: A comparison of multiple doses of fluticasone propionate and beclomethasone dipropionate in subjects with persistent asthma. J Allergy Clin. Immunol (1999) 103:796–803.
  • •A study evaluating pharmacodynamically equivalent doses of FP and BDP delivered by MDI in patients with moderate-to-severe asthma.
  • SHEFFER AL, LAFORCE C, CHERVINSKY P, PEARLMAN D, SCHABERG A: Fluticasone propionate aerosol: efficacy in patients with mild to moderate asthma. J Fam. Pract. (1996) 42:369–375.
  • •A study evaluating FP aerosol in patients whose asthma was inadequately controlled by as needed inhaled I3-agonists.
  • WOLFE JD, SELNER JC, MENDELSON LM, HAMPEL F, SCHABERG A: Effectiveness of fluticasone propionate in patients with moderate asthma: a dose-ranging study. Clin. Therap. (1996) 1 8 (4):635–646.
  • •A 12 week study evaluating 3 doses of FP delivered by MDI compared to placebo in patients already receiving ICS therapy.
  • CONDEMI JJ, CHERVINSKY P, GOLDSTEIN MF et al.: Fluticasone propionate powder administered through diskhaler versus triamcinolone acetonide aerosol administered through metered-dose inhaler in patients with persistent asthma. J. Allergy Clin. Immunol. (1997) 100 :467–474.
  • •A study which documents clinical superiority of FP 500 fig/day to TAA 800 fig/day.
  • BARANIUK J, MURRAY JJ, NATHAN RA: Fluticasone alone or in combination with salmeterol vs. triamcinolone in asthma. CHEST (1999) 116:625–632.
  • •A study reporting the potency superiority of FP compared with TAA.
  • HEINIG JH, BOULET LP, CROONENBORGHS L, MOLLERS MJ: The effect of high-dose fluticasone propionate and budesonide on lung function and asthma exacerba-tions in patients with severe asthma. Respir. Med. (1999) 93:613–620.
  • •A prospective evaluation of equal lig doses of FP and BUD on exacerbations of asthma.
  • GALANT SP, LAWRENCE M, MELTZER EO, TOMASKO M, BAKER KA, KELLERMAN DJ: Fluticasone propionate compared with theophylline for mild-to-moderate asthma. Ann. Allergy Asthma Immunol. (1996) 77:112–118.
  • •A study evaluating two doses of FP delivered by MDI compared to adjusted-dose theophylline.
  • NIMMAGADDA SR, SPAHN JD, NELSON HS, JENKINS J, SZEFLER SJ, LEUNG DYM: Fluticasone propionate results in improved glucocorticoid receptor binding affinity and reduced oral glucocorticoid requirements in severe asthma. Ann. Allergy Asthma Immunol. (1998) 81:35–40.
  • •A study evaluating high dose FP, delivered by DPI, on glucocorticoid receptor binding affinity.
  • NOONAN M, CHERVINSKY P, BUSSE W et al.: Fluticasone propionate reduces oral prednisone use while it improves asthma control and quality of life. Am. J Respir. Crit. Care Med. (1995) 152:1467–1473.
  • •A study that reports an improvement in quality of life of patients after they are initiated on FP with subsequent tapering of their daily dose of oral prednisone.
  • LEVY ML, STEVENSON C, MASLEN T: Comparison of short courses of oral prednisolone and fluticasone propionate in the treatment of adults with acute exacerbations of asthma in primary care. Thorax (1996) 51:1087–1092.
  • •Prospective evaluation of FP versus oral prednisone for exacerbations of asthma that do not fulfil hospitalisation criteria.
  • MAHAJAN P, OKAMOTO LJ, SCHABERG A, KELLERMAN D, SCHOENWETTER WF: Impact of fluticasone propionate powder on health-related quality of life in patients with moderate asthma. J Asthma (1997) 34(3):227–234.
  • •Study evaluating general and asthma specific quality of life in patients receiving either FP or placebo.
  • MAHAJAN P, PEARLMAN D, OKAMOTO L: The effect of fluticasone propionate on functional status and sleep in children with asthma and on the quality of life of their parents. J. Allergy Clin. Immunol. (1998) 102:19–23.
  • •Reports of quality of life in children and parents using general and asthma specific quality of life instruments as part of a larger randomised controlled trial with FP. Exp. Opin. Pharmacother. (2000) 1(6)
  • OKAMOTO LJ, NOONAN M, DEBOISBLANC BP, KELLERMAN DJ: Fluticasone propionate improves quality of life in patients with asthma requiring oral corticosteroids. Ann. Allergy Asthma Immunol (1996) 76:455–461.
  • •Study evaluating quality of life in oral steroid-dependent asthmatics, showing sustained improvements in quality of life over 1 year.
  • BALKRISHNAN R, NORWOOD GJ, ANDERSON A: Outcomes and cost benefits associated with the introduction of inhaled corticosteroid therapy in a medicaid population of asthmatic patients. Clin. Ther. (1998) 20(3):567–580.
  • •An evaluation of reimbursement databases of Medicaid to determine the benefit of ICS on costs of healthcare utilisation.
  • DONAHUE JG, WEISS ST, LIVINGSTON JM, GOETSCH MA, GREINEDER DK, PLATT R: Inhaled steroids and the risk of hospitalization for asthma. JAMA. (1997) 277(10:887–891.
  • •Retrospective analysis of a USA-Health Maintenance Organisation's ICS treatment of asthma reduces the risk of asthma hospitalisation.
  • BARNES NC, THWAITES MA, PRICE MJ: The cost-effectiveness of inhaled fluticasone propionate and budesonide in the treatment of asthma in adults and children. Respir. Med. (1999) 93:402–407.
  • •A meta analysis taken from the perspective of the health care system comparing FP with BUD using pharmacodynamic equivalent doses.
  • VOLMER T, KIELHORN A, WEBER HH, WIESSMANN: Cost effectiveness of fluticasone propionate and flunisolide in the treatment of corticosteroid-naive patients with moderate asthma. Pharmacoeconomics (1999) 16(5 Pt 2):525–531.
  • •An analysis of direct treatment costs when applied to 2 prospective clinical trials comparing FP and FLU the perspective of the German Healthcare system.
  • PRICE DB, APPLEBY JL: Fluticasone propionate: an audit of outcomes and cost-effectiveness in primary care. Respir. Med. (1998) 92:351–353.
  • •A retrospective audit of asthma treatment with FP and the costs and cost savings in a primary care setting.
  • STEINMETZ KO, VOLMER T, TRAUTMAN M: Cost effectiveness of fluticasone and budesonide in patients with moderate asthma. Clin. Drug Invest. (1998) 16:117–123.
  • •An evaluation of the cost-effectiveness of FP versus BUD using a German third-party payer perspective.
  • PRICE JF, RUSSELL G, HINDMARSH BC, WELLER P, HEAF DP, WILLIAMS J: Growth during one year of treatment with fluticasone propionate or sodium cromoglycate in children with asthma. Pediatr. Pulmonol (1997) 24:178–186.
  • •A study comparing the effects of FP and cromolyn on growth velocity in children with asthma.
  • ALLEN DB, BRONSKY EA, LAFORCE CF et al.: Growth in asthmatic children treated with fluticasone propionate. J Pediatr. (1998) 132:472–477.
  • •A well designed study evaluating the growth effects of FP on children with asthma.
  • KANNISTO S, KORPPI M, REMES K, VOUTILAINEN: Adrenal suppression evaluated by a low dose adreno-corticotropin test, and growth in asthmatic children treated with inhaled steroids. J. Clin. Endocrinol. Metab. (2000) 85 :652–657.
  • •A study evaluating growth in children with asthma treated with FP, BUD or cromolyn.
  • BOOTSMA GP, DEKHUIJZEN PNR, FESTEN J, MULDER PGH, SWINKELS LMJW, VAN HERWAARDEN CLA: Flutica-sone propionate does not influence bone metabolism in contrast to beclomethasone dipropionate. Am. J Respir. Grit. Care Med. (1996) 153:924–930.
  • •A short-term study evaluating FP effects on bone markers of formation and resorption.
  • HUGHES J, CONRY B, MALE S, EASTELL RA: A phase III open parallel group study to compare the effects of inhaled fluticasone propionate (FP) (500mcg BD) and budesonide (BUD) (800mcg BD) on bone density measurements (BMD) over 1 year in stable chronic asthmatics. Thorax (1996) 51 (Suppl 3):A72.
  • •An abstract describing neutral bone effects of both FP and BUD over a 1 year period.
  • PAUWELS RA, YERNAULT JC, DEMEDTS MG, GEUSENS P: Safety and efficacy of fluticasone and beclomethasone in moderate to severe asthma. Am. J. Respir. Grit. Care Med. (1998) 157:827–832.
  • •A long-term study of the advantage of FP compared to BDP on BMD.
  • MEDICI TC, GREBSKI E, HACKI M, REUGSEGGER P, MADEN C, EFTHIMIOU I: One-year treatment with inhaled fluticasone propionate or beclomethasone dipropionate does not affect bone density and bone metabolism. A randomized, parallel group study in adult asthmatics. Am. J. Respir. Grit. Care Med. (1998) 157:A407.
  • •An abstract describing the neutral effects of low-dose FP on BMD.
  • OSUR S, CHERVINSKY P, HERJE N, HARDING S, KELLERMAN D: Long term effects of fluticasone propionate (FP) inhalation aerosol in subjects with asthma. Am. J. Respir. Grit. Care Med. (1998) 157:A405.
  • •An abstract describing neutral effects of FP on lumbar BMD.
  • GREGSON RK, RAO R, MURRILLS AJ, TAYLOR PA, WARNER JO: Effects of inhaled corticosteroids on bone mineral density in childhood asthma: comparison of flutica-sone propionate with beclomethasone dipropionate. Osteoporos. Int. (1998) 8:418–422.
  • •A long-term study showing neutral effects of both FP and BDP in prepubertal children with asthma.
  • EGAN JJ, MADEN C, KALRA S, ADAMS JE, EASTELL R, WOODCOCK AA: A randomized, double-blind study comparing the effects of beclomethasone and flutica-sone on bone density over two years. Eur. Respir. (1999) 13:1267–1275.
  • •A long-term study in adults describing the advantage of FP compared to BDP on bone health.
  • MALO JL, CARTIER A, GHEZZO H et al: Skin bruising, adrenal function and markers of bone metabolism in asthmatics using inhaled beclomethasone and flutica-sone. Eur. Repsir. J (1999) 13:993–998.
  • •A short-term crossover study describing modest benefit of FP compared to BDP.
  • LI JT, FORD LB, CHERVINSKY P et al: Fluticasone propionate powder and lack of clinically significant effects on hypothalamic-pituitary-adrenal axis and bone mineral density over 2 years in adults with mild asthma. J. Allergy Clin. Immunol. (1999) 103:1062–1068.
  • •A long-term study describing the neutral effects of FP on bone health compared to PB.
  • BARNES PJ, PEDERSON S, BUSSE WW: Efficacy and safety of inhaled corticosteroids. Am. J Respk. Grit. Care Med. (1998) 157:S1–53.
  • •A review of the published efficacy and safety of ICS.
  • DLUHY RG: Clinical relevance of inhaled corticoster- oids and HPA axis suppression. J. Allergy Clin. Immunol. (1998) 101 :S447–450.
  • •A thorough review of the clinical relevance of adrenal axis effects of ICS.
  • SORKNESS CA, HERJE NE, HARDING SM: Subject response to ACTH stimulation after three-fours of treatment with fluticasone propionate (FP) inhalation aerosol. Am. J. Respir. Grit. Care Med. (1997) 155:A354.
  • •An abstract describing the safety of long-term FP use in patients with prior maintenance on oral corticosteroids.
  • WOLFE J, ROOKLIN A, GRADY J et al.: Comparison of once- and twice-daily dosing of fluticasone propionate 200 micrograms per day administered by diskus device in patients with asthma treated with or without inhaled corticosteroids. J. Allergy Clin. Immunol (2000) 105:1153–1161.
  • •A study that reports that once- and twice-daily FP regimens are comparable with respect to lung function and once daily dosing was able to maintain the patient's asthma stability.
  • SHREWSBERRY S, PYKE S, BRITTON M: A meta-analysis of increasing inhaled steroid or adding salmeterol in symptomatic asthma (MIASMA). Br. Med. J (2000) 320:1368–1373.
  • •A meta-analysis reporting that adding salmeterol to FP has greater clinical efficacy than increasing the dose of FP.
  • HOEKX JCM, HEDLIN G, PEDERSON W, SORVA R, HOLLINNGWORTH K, EFTHIMIOU J: Fluticasone propionate compared with budesonide: a double-blind trial in asthmatic children using powder devices at a dosage of 4001g/day. Eur. Respir. J. (1996) 9:2263–2272.
  • •A controlled trial evaluating equal lig doses of FP and BUD on lung function.

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