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Inhaled Fluticasone Propionate

A Review of its Therapeutic Efficacy at Dosages ≤ 500 µg/day in Adults and Adolescents with Mild to Moderate Asthma

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Summary

Abstract

Fluticasone propionate is a corticosteroid with comparatively high receptor affinity and topical activity. Inhaled fluticasone propionate ≤500 µg/day provided effective corticosteroid maintenance treatment in patients with mild to moderate asthma in randomised, controlled clinical studies of 4 to 24 weeks in duration. Dosages of 50 to 250µg twice daily produced consistent improvement in spirometric measures of lung function, reduced the frequency of as-needed β2-agonist bronchodilator use, asthma symptom scores and night-time wakenings, and prevented asthma exacerbations compared with placebo. Fluticasone propionate ≤250µg twice daily provided significantly greater improvements in lung function than nedocromil 4mg 4 times daily, theophylline (5 to 15 mg/L) or zafirlukast 20mg twice daily. Health-related quality of life improved significantly with fluticasone propionate 88µg twice daily, but not zafirlukast 20mg twice daily or placebo. In comparative trials in which fluticasone propionate was given at half the dosage of beclomethasone dipropionate, budesonide or flunisolide, fluticasone propionate ≤250µg twice daily produced equivalent or greater improvement in spirometric parameters and equivalent reductions in the use of as-needed β2-agonists than beclomethasone dipropionate, budesonide or flunisolide. Fluticasone propionate 250µg twice daily was generally more effective than triamcinolone acetonide 200µg 4 times daily in two 24-week trials.

The combination of inhaled fluticasone propionate ≤250 plus salmeterol ≤50µg twice daily allowed for the use of lower dosages of the inhaled corticosteroid.

The incidence of adverse events in patients receiving inhaled fluticasone propionate 50 to 250µg twice daily was similar to that in beclomethasone dipropionate 168 to 500µg twice daily and budesonide 100 to 600µg twice daily recipients and greater than that in recipients of triamcinolone acetonide 200µg 4 times daily in comparative trials. The incidence of oral candidiasis was ≤8% in patients treated with fluticasone propionate ≤250µg twice daily or other agents. There was no evidence of clinically significant hypothalamo-pituitary-adrenal (HPA) axis suppression with fluticasone propionate ≤250µg twice daily in comparative trials.

Conclusions. Inhaled fluticasone propionate ≤500 µg/day is an effective anti-inflammatory therapy for mild to moderate asthma in adolescents and adults. The drug is more effective than nedocromil, theophylline or zafirlukast and is at least as effective as other inhaled corticosteroids administered at twice the fluticasone propionate dosage. The addition of inhaled salmeterol allows the use of lower maintenance dosages of fluticasone propionate. The drug is well tolerated and there is no evidence of a clinically significant effect of this dosage on HPA axis function. Hence, fluticasone propionate ≤500 µg/day is a particularly suitable agent for patients with mild to moderate asthma.

Pharmacological Properties

Fluticasone propionate ≤250µg twice daily attenuates antigen processing, suppresses recruitment and activation of inflammatory cells and reduces the thickness of the basement membrane in the airways of patients with mild asthma. At dosages ranging from 100 to 250 µg/day the drug generally reduced bronchial hyperresponsiveness, as measured by the dose of inhaled histamine, methacholine or adenosine 5′-monophosphate required to provoke a 20% decline (PD20) in forced expiratory volume in 1 second (FEV1) in patients with mild to moderate asthma. The PD20 for histamine was significantly greater after 2 weeks’ treatment with fluticasone propionate 100µg twice daily than zafirlukast 20mg twice daily in a crossover study. Fluticasone propionate 250µg and salmeterol 50µg, each given alone or in combination, reduced bronchial hyperresponsiveness in patients with significant diurnal variation in the PD20 of methacholine.

In general, fluticasone propionate ≤250µg twice daily had minimal effects on hypothalamo-pituitary-adrenal (HPA) axis function in adult patients with mild to moderate asthma enrolled in placebo-controlled studies and there was no difference in HPA axis function when fluticasone propionate dosages ≤500 µg/day were compared with other inhaled corticosteroids in clinical trials.

Plasma concentrations of fluticasone propionate were below the limit of detection (<0.025 µg/L) after inhalation of 100µg twice daily for 4 weeks. Concentrations of the drug in peripheral lung tissue exceeded those in plasma by approximately 100-fold and fluticasone propionate could be detected in lung tissue and serum for 16.3 and 13.3 hours, respectively, after inhalation of a single 1000µg dose prior to pneumonectomy or lobe resection. The oral and pulmonary bioavailability of fluticasone propionate was, respectively, <1% and 14.9% in healthy volunteers. The terminal elimination half-life of fluticasone propionate was 7.6 to 14.4 hours after inhalation of a single 1000µg dose or inhalation of 1000µg twice daily for 7 days from a dry powder inhaler.

Therapeutic Efficacy

Fluticasone propionate 50 to 500 µg/day produced improvements in lung function in patients with mild to moderate persistent asthma in randomised, comparative trials of 4 to 24 weeks’ duration. Improvements in morning and evening peak expiratory flow rate (PEF) and FEV1 in patients treated with fluticasone propionate 25 to 250µg twice daily were generally significantly greater than in those treated with placebo, inhaled nedocromil 4mg 4 times daily, oral theophylline (titrated to plasma concentrations of 5 to 15 mg/L) or oral zafirlukast 20mg twice daily. In comparative trials with inhaled beclomethasone 168 to 500µg twice daily, budesonide 200 to 600µg twice daily or flunisolide 500µg twice daily, in which fluticasone propionate was given at half or less than half the microgram dosage of the other inhaled corticosteroid (i.e. fluticasone propionate 50 to 250µg twice daily), improvements in morning and/or evening PEF in fluticasone propionate recipients were generally similar to, or significantly greater than, those in patients treated with the comparator. In two 24-week trials, improvements in morning PEF and FEV1 after 24 weeks were significantly greater in fluticasone propionate 250µg twice daily recipients than in triamcinolone acetonide 200µg 4 times daily or placebo recipients.

In concert with improvements in lung function, requirements for as-needed β2-agonists and nocturnal awakenings generally decreased and asthma symptoms improved in patients treated with fluticasone propionate 25 to 250µg twice daily in comparative trials. The frequency of as-needed β2-agonist use decreased significantly in fluticasone propionate 25 to 250µg twice daily recipients compared with those receiving placebo, nedocromil 4mg 4 times daily or zafirlukast 20mg twice daily. Recipients of fluticasone propionate 100 but not 50µg twice daily used significantly less supplementary salbutamol compared with theophylline-treated patients. The frequency of as-needed β2-agonist use decreased from baseline in comparative trials in which fluticasone propionate was administered at half or less than half the microgram dose of beclomethasone dipropionate 200 to 336µg twice daily or budesonide 200 or 400µg twice daily. Furthermore, requirements for supplementary salbutamol decreased significantly in patients treated with fluticasone propionate 250µg twice daily compared with those receiving triamcinolone acetonide 200µg 4 times daily or placebo.

The frequency of withdrawal from comparative trials because of loss of efficacy generally declined in patients treated with fluticasone propionate 25 to 250µg twice daily. More than half (52 to 71%) of the placebo-treated patients withdrew from 5 of 7 placebo controlled trials because of asthma exacerbations; however, the frequency of withdrawal was significantly lower in fluticasone propionate 25 to 250µg twice daily recipients (6 to 37%) with no statistical differences between fluticasone propionate dosage groups. Loss of efficacy was significantly less frequent in fluticasone propionate 250µg twice daily (15%) than nedocromil 4mg 4 times daily recipients (27%) in 1 trial, but not in a second. Significantly fewer fluticasone propionate 50 or 100µg twice daily recipients experienced asthma exacerbations (≤19%) compared with those receiving theophylline (38%) or placebo (52%) during a 12-week trial. Withdrawal because of loss of efficacy occurred infrequently in comparative trials involving fluticasone propionate 50 to 250µg twice daily and beclomethasone dipropionate 200 to 500µg twice daily (≤20.8%) or budesonide 100 to 600µg twice daily (≤7.8%) with no significant differences between treatment groups. Loss of efficacy was significantly less frequent in fluticasone propionate 250µg twice daily (17%) or triamcinolone acetonide 200µg 4 times daily recipients (≤33%) than placebo (≤65%) in two 24 week trials, in 1 of which there was a significant difference in the frequency of loss of efficacy between fluticasone propionate and triamcinolone acetonide groups.

Fluticasone propionate ≤250µg twice daily had a beneficial effect on health-related quality of life (QOL) in patients with mild to moderate asthma. Health status, as measured by a disease-specific instrument (Living with Asthma), sleep patterns, and scores on the physical functioning and role-physical dimensions of the Medical Outcomes Study Short Form-36 (SF-36) improved significantly in fluticasone 50, 100 and 250µg twice daily recipients compared with placebo. Those in the 2 higher dosage groups also had significantly higher SF-36 scores in health perceptions, vitality and mental health compared with placebo.

In other studies, QOL was measured with the Asthma Quality of Life Questionnaire (AQLQ). Global AQLQ scores and scores on each of the 4 domains (Activity Limitation, Asthma Symptoms, Emotional Function and Environmental Exposure) were significantly higher after 12 weeks treatment with fluticasone propionate 88µg twice daily than either zafirlukast 20mg twice daily or placebo and more patients treated with fluticasone propionate than zafirlukast or placebo experienced moderate or large improvements in Global AQLQ scores. In another study Global AQLQ scores and scores on 3 of the 4 domains on the scale (all except Environmental Exposure) were significantly higher after 24 weeks of treatment with fluticasone propionate 250µg twice daily than with either triamcinolone acetonide 200µg 4 times daily or placebo. Moreover, the difference in global AQLQ scores between fluticasone propionate and placebo recipients was considered to be clinically significant.

Combining inhaled salmeterol with fluticasone propionate may improve asthma control and allow for the use of a lower fluticasone propionate dosage. The combination of salmeterol 42µg plus fluticasone propionate 220µg twice daily produced significantly greater improvements in FEV1 compared with either drug given separately. Loss of efficacy was significantly less frequent in those treated with salmeterol 50µg plus fluticasone propionate 100µg twice daily (5%) compared with either drug given alone (≤24%) or placebo (44%).

Equivalent daily dosages of fluticasone propionate ≤500 µg/day administered once or twice daily improved or maintained lung function in patients with mild to moderate asthma. However, twice daily, compared with once daily administration generally provided numerically greater improvement in morning and evening PEF.

Tolerability

The incidence of adverse effects was generally not significantly different in patients treated with inhaled fluticasone propionate ≤250µg twice daily or placebo in comparative studies. Withdrawal because of adverse events occurred in ≤4% and ≤2% of fluticasone propionate and placebo recipients, respectively. Oral candidiasis and dysphonia (hoarseness) or pharyngitis were reported by ≤6% and ≤3% of fluticasone propionate and placebo recipients, respectively.

In trials comparing fluticasone propionate ≤250µg twice daily with either beclomethasone dipropionate or budesonide, the frequency of adverse events was similar between groups. Oral candidiasis was reported by ≤6.5% of patients receiving fluticasone propionate or the other inhaled corticosteroid in these studies.

The frequency of treatment-related adverse events was significantly greater in patients treated with fluticasone propionate 250µg twice daily (20%) than either triamcinolone acetonide 200µg 4 times daily (5%) or placebo (5%) in 1 trial. In a second, similar trial, the incidence of oral candidiasis was significantly greater in fluticasone propionate 250µg twice daily recipients (8%) than either triamcinolone acetonide 200µg 4 times daily (3%) or placebo recipients (1%).

In trials comparing fluticasone propionate ≤250µg twice daily with other inhaled corticosteroids or nedocromil <10% of patients were withdrawn from any treatment group because of adverse events.

Dosage and Administration

In the UK the recommended dosage of inhaled fluticasone propionate for patients aged ≥16 years with mild asthma is 100 to 250µg twice daily and for those with moderate asthma, 250 to 500µg twice daily.

In the US, the recommended dosage in patients ≥12 years of age is 88 to 440µg twice daily by metered dose inhaler or 100 to 500µg twice daily by dry powder inhaler.

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References

  1. Legorreta AP, Christian-Herman J, O’Connor RD, et al. Compliance with national asthma management guidelines and specialty care. A health maintenance organization experience. Arch Intern Med 1998; 158: 457–64

    Article  PubMed  CAS  Google Scholar 

  2. Lange P, Ulrik CS, Vestbo J, et al. Mortality in adults with self-reported asthma. Lancet 1996; 347: 1285–9

    PubMed  CAS  Google Scholar 

  3. Lange P, Parner J, Vestbo J, et al. A 15-year follow-up study of ventilatory function in adults with asthma. N Engl J Med 1998; 339: 1194–200

    Article  PubMed  CAS  Google Scholar 

  4. Barnes PJ. Current issues for establishing inhaled corticosteroids as the antiinflammatory agents of choice in asthma. J Allergy Clin Immunol 1998; 101 (4 Pt 2): S427–33

    Article  PubMed  CAS  Google Scholar 

  5. Meijer RJ, Kerstjens HAM, Postma DS. Comparison of guidelines and self-management plans in asthma. Eur Respir J 1997; 10: 1163–72

    Article  PubMed  CAS  Google Scholar 

  6. National Heart Lung and Blood Institute. Global strategy for asthma management and prevention. NHLBI/WHO workshop report. National Institutes of Health. National Heart, Lung, and Blood Institute. 1995 Jan; Publication Number 95-3659

  7. British Thoracic Society. The British guidelines on asthma management 1995 review and position statement. Thorax 1997 Feb; 52 Suppl. 1: S1–21

    Article  Google Scholar 

  8. National Asthma Education and Prevention Program. Expert Panel report II: guidelines for the diagnosis and management of asthma. Bethesda: National Heart, Lung, and Blood Institute Information Center. 1997 Feb.

  9. Holliday SM, Faulds D, Sorkin EM. Inhaled fluticasone propionate: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in asthma. Drugs 1994 Feb; 47: 318–31

    Article  PubMed  CAS  Google Scholar 

  10. Rahman SU, Rhodes CG, Ind PW, et al. Effect of corticosteroids on pulmonary β adrenergic receptor density and function [abstract no. P1103]. Eur Respir J 1998; 12 Suppl. 28: 156s

    Google Scholar 

  11. Barnes PJ. Inhaled glucocorticoids for asthma. N Engl J Med 1995 Mar 30; 332: 868–75

    Article  PubMed  CAS  Google Scholar 

  12. Olivieri D, Chetta A, Del Donno M, et al. Effect of short-term treatment with low-dose inhaled fluticasone propionate on airway inflammation and remodeling in mild asthma: a placebo-controlled study. Am J Respir Crit Care Med 1997 Jun; 155: 1864–71

    PubMed  CAS  Google Scholar 

  13. Bertorelli G, Bocchino V, Zhuo X, et al. Heat shock protein 70 upregulation is related to HLA-DR expression in bronchial asthma. Effects of inhaled glucocorticoids. Clin Exp Allergy 1998; 28: 551–60

    Article  PubMed  CAS  Google Scholar 

  14. Noonan MJ, Chervinsky P, Wolfe J, et al. Dose-related response to inhaled fluticasone propionate in patients with methacholine-induced bronchial hyperresponsiveness: a double-blind placebo-controlled study. J Asthma 1998; 35: 153–64

    Article  PubMed  CAS  Google Scholar 

  15. Westbroek J, Pasma HR. The effect of inhaled fluticasone propionate (FP) 100 µg bd compared with oral zafirlukast 20 mg bd on bronchial hyperresponsiveness in mild to moderate asthma. Eur Respir J 1997 Sep; (10 Suppl. 25): 243s

  16. Weersink EJM, Douma RR, Postma DS. Fluticasone propionate, salmeterol xinafoate, and their combination in the treatment of nocturnal asthma. Am J Respir Crit Care Med 1997 Apr; 155: 1241–6

    PubMed  CAS  Google Scholar 

  17. Lipworth BJ. Airway and systemic effects of inhaled corticosteroids in asthma: dose response relationship. Pulmon Pharmacol 1996 Feb; 9: 19–27

    Article  CAS  Google Scholar 

  18. Lipworth BJ, Seckl JR. Measures for detecting systemic bioactivity with inhaled and intranasal corticosteroids. Thorax 1997; 52: 476–82

    Article  PubMed  CAS  Google Scholar 

  19. Chervinsky P, van As A, Bronsky EA, et al. Fluticasone propionate aerosol for the treatment of adults with mild to moderate asthma. J Allergy Clin Immunol 1994 Oct; 94: 676–83

    Article  PubMed  CAS  Google Scholar 

  20. Lawrence M, Wolfe J, Webb DR, et al. Efficacy of inhaled fluticasone propionate in asthma results from topical and not from systemic activity. Am J Respir Crit Care Med 1997 Sep; 156 (Pt 1): 744–51

    PubMed  CAS  Google Scholar 

  21. 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): 265–74

    Article  PubMed  CAS  Google Scholar 

  22. Pearlman DS, Noonan MJ, Tashkin DP, et al. Comparative efficacy and safety of twice daily fluticasone propionate powder versus placebo in the treatment of moderate asthma. Ann Allergy Asthma Immunol 1997 Apr; 78: 356–62

    Article  PubMed  CAS  Google Scholar 

  23. Kellerman D, Stricker W, Howland W, et al. Effects of inhaled fluticasone propionate (FP) on the HPA axis of patients with asthma [abstract]. Eur Respir J 1996 Sep; 9 Suppl. 23: 162s

    Google Scholar 

  24. Harding SM, Herje NE, Hamedani AG. Comparison of the long-term effects of inhaled fluticasone propionate (FP) on the HPA axis in patients with asthma [abstract]. Ann Allergy Asthma Immunol 1997 Jan; 78: 156

    Google Scholar 

  25. Dahl R, Lundback B, Malo JL, et al. A dose-ranging study of fluticasone propionate in adult patients with moderate asthma. International Study Group. Chest 1993 Nov; 104: 1352–8

    Article  PubMed  CAS  Google Scholar 

  26. Derom E, Van Schoor J, Vincken W, et al. A comparison of the systemic activity of 2 doses of inhaled fluticasone propionate and budesonide in asthmatic patients [abstract]. American Lung Association/American Thoracic Society 1997 International Conference, San Francisco, CA 1997 May 16–21: 41

    Google Scholar 

  27. Connolly A,UK Study Group. Acomparison of fluticasone propionate 100 µg twice daily with budesonide 200 µg twice daily via their respective powder devices in the treatment of mild asthma. Eur J Clin Res 1995; 7: 15–29

    Google Scholar 

  28. Langdon CG, Capsey LJ, UK Study Group. Fluticasone propionate and budesonide in adult asthmatics: a comparison using dry-powder inhaler devices. Br J Clin Res 1994; 5: 85–99

    Google Scholar 

  29. Langdon CG, Thompson J, Uk SG, et al. A multicentre study to compare the efficacy and safety of inhaled fluticasone propionate and budesonide via metered-dose inhalers in adults with mild-to-moderate asthma. Br J Clin Res 1994; 5: 73–84

    Google Scholar 

  30. Grahnen A, Brundin RM, Ling-Andersson A, et al. Systemic potency of fluticasone propionate vs budesonide, from dry powder inhalers [abstract no. P1071]. Eur Respir J 1996; 9 Suppl. 23: 164s

    Google Scholar 

  31. Wilson AM, Clark DJ, Devlin MM, et al. Adrenocortical activity with repeated administration of once-daily inhaled fluticasone propionate and budesonide in asthmatic adults. Eur J Clin Pharmacol 1998; 53: 317–20

    Article  PubMed  CAS  Google Scholar 

  32. Wilson AM, McFarlane LC, Lipworth BJ. Dose-response effect for adrenal suppression with repeated twice daily inhaled fluticasone propionate and triamcinolone acetonide in adult asthmatics. Am J Respir Crit Care Med 1997 Oct; 156 (Pt 1): 1274–7

    PubMed  CAS  Google Scholar 

  33. Storms W, Howland WC, Sorkness CA, et al. Fluticasone propionate (FP), triamcinolone acetonide (TAA) and flunisolide (FLN) have similar effects on the HPA axis [abstract]. J Allergy Clin Immunol 1997 Jan; 99 (Pt 2): 318

    Google Scholar 

  34. Li J, Gross G, Osur S, et al. A comparison of commonly-prescribed doses of inhaled fluticasone propionate (FP) and inhaled triamcinolone acetonide (TAA) on HPA axis function. Am J Respir Crit Care Med 1998 Mar; 157 (3 Pt 2): A407

    Google Scholar 

  35. Tita J, LaForce C, Howland WC, et al. Use of 6-hr cosyntropin stimulation tests to evaluate potential effects of inhaled fluticasone propionate (FP), inhaled triamcinolone acetonide (TAA), placebo (PBO) and oral prednisone on HPA axis function [abstract]. Am J Respir Crit Care Med 1997; 155 (4 Pt 2): A355

    Google Scholar 

  36. Srebro SH, Rogenes PR, Edwards L et al. Comparison of efficacy and HPA effects of fluticasone propionate versus flunisolide in patients with mild to moderate asthma [abstract]. Am J Respir Crit Care Med 1998 Mar; 157 (Suppl. Pt 2): 406

    Google Scholar 

  37. Leblanc P, Mink S, Keistinen T, et al. A comparison of fluticasone propionate 200 µg/day with beclomethasone dipropionate 400 µg/day in adult asthma. Allergy 1994 May; 49: 380–5

    Article  PubMed  CAS  Google Scholar 

  38. Clark DJ, Lipworth BJ. Adrenal suppression with chronic dosing of fluticasone propionate compared with budesonide in adult asthmatic patients. Thorax 1997 Jan; 52: 55–8

    Article  PubMed  CAS  Google Scholar 

  39. Falcoz C, Mackie AE, Moss J, et al. Pharmacokinetics of fluticasone propionate inhaled from the Diskhaler and the Diskus powder devices in asthmatic patients [abstract]. Br J Clin Pharmacol 1997 May; 43: 541–2

    Google Scholar 

  40. Meibohm B, Mollmann H, Wagner M, et al. The clinical pharmacology of fluticasone propionate. Rev Contemp Pharmacother 1998; 9: 535–49

    CAS  Google Scholar 

  41. Kelly HW Establishing a therapeutic index for the inhaled corticosteroids. Part I pharmacokinetic/pharmacodynamic comparison of the inhaled corticosteroids. J Allergy Clin Immunol 1998; 102 (4 Pt 2): S36–51

    Article  PubMed  CAS  Google Scholar 

  42. Derendorf H, Hochhaus G, Meibohm B, et al. Pharmacokinetics and pharmacodynamics of inhaled corticosteroids. J Allergy Clin Immunol 1998; 101 (4 Pt 2): S440–6

    Article  PubMed  CAS  Google Scholar 

  43. Thorsson L, Dahlstrom K, Edsbacker S, et al. Pharmacokinetics and systemic effects of inhaled fluticasone propionate in healthy subjects. Br J Clin Pharmacol 1997; 43: 155–61

    Article  PubMed  CAS  Google Scholar 

  44. Esmailpour N, Hogger P, Rabe KF, et al. Distribution of inhaled fluticasone propionate between human lung tissue and serum in vivo. Eur Respir J 1997; 10: 1496–9

    Article  PubMed  CAS  Google Scholar 

  45. Inhaled fluticasone propionate prescribing information. Research Triangle Park, NC, USA, Glaxo Wellcome Ltd. 1998

  46. Falcoz C, Mackie AE, Moss J, et al. Pharmacokinetics of fluticasone propionate inhaled from the Diskhaler and the Diskus after repeat doses in healthy subjects and asthmatic patients [abstract no. 2041]. J Allergy Clin Immunol 1997; 99 (1 Pt 2): S505

    Google Scholar 

  47. Mackie AE, Ventresca GP, Fuller RW, et al. Pharmacokinetics of intravenous fluticasone propionate in healthy subjects. Br J Clin Pharmacol 1996; 41: 539–42

    Article  PubMed  CAS  Google Scholar 

  48. Mackie A, Falcoz C, McDowall J, et al. Pharmacokinetics of fluticasone propionate inhaled from the Diskhaler (Rm) and the Diskus (Rm) powder devices in healthy subjects. Br J Clin Pharmacol 1997 May; 43: 540–1

    Google Scholar 

  49. Sheffer AL, Laforce C, Chervinsky P, et al. Fluticasone propionate aerosol: efficacy in patients with mild to moderate asthma. J Fam Pract 1996 Apr; 42: 369–75

    PubMed  CAS  Google Scholar 

  50. Wolfe JD, Selner JC, Mendelson LM. Effectiveness of fluticasone propionate in patients with moderate asthma: a dose-ranging study. Clin Ther 1996 Jul–Aug; 18: 635–46

    Article  PubMed  CAS  Google Scholar 

  51. Mahajan P, Okamoto LJ, Schaberg A. Impact of fluticasone propionate powder on health-related quality of life in patients with moderate asthma. J Asthma 1997; 34(3): 227–34

    Article  PubMed  CAS  Google Scholar 

  52. Galant SP, Lawrence M, Meltzer EO, et al. Fluticasone propionate compared with theophylline for mild-to-moderate asthma. Ann Allergy Asthma Immunol 1996 Aug; 77: 112–8

    Article  PubMed  CAS  Google Scholar 

  53. Pauli G, Aubert B, French SG. A comparison of inhaled fluticasone propionate with nedocromil in the treatment of moderate adult asthma. Eur J Clin Res 1995; 7: 45–56

    Google Scholar 

  54. Grison R, Pellegrino R, D’Amato G, et al. Comparison of inhaled fluticasone propionate 250 mcg bd and inhaled nedocromil sodium 4mg QDS both administered with inhaled or oral long acting bronchodilators over three month period in adult with unstable chronic asthma [abstract no. P1184]. Eur Respir J 1997 Sep; 10 Suppl. 25: 174s

    Google Scholar 

  55. Johnson MC, Matz J, Srebro S, et al. Greater improvement in asthma control with fluticasone propionate than with either zafirlukast or placebo. Chest 1998; 114 Suppl. 4: 296s

    Google Scholar 

  56. Lundback B, Alexander M, Day J, et al. Evaluation of fluticasone propionate (500 µg day−1) administered either as dry powder via a Diskhaler inhaler or pressurized inhaler and compared with beclomethasone dipropionate (1000 µg day−1) administered by pressurized inhaler. Respir Med 1993; 87: 609–20

    Article  PubMed  CAS  Google Scholar 

  57. Rapheal GD, Baker JW, Chervinsky P, et al. Low dose fluticasone propionate (FP) is more effective than higher doses of beclomethasone dipropionate (BDP) in patients with mild to moderate asthma [abstract no. 24]. J Allergy Clin Immunol 1998 Jan; 101: S6

    Google Scholar 

  58. Miyamoto T, Takishima T, Makino S, et al. Clinical examination of fluticasone propionate dry powder — comparison between beclomethasone dipropionate inhaler in bronchial asthma [in Japanese]. Rinsho Iyaku 1994; 10(2): 321–45

    CAS  Google Scholar 

  59. Basran G, Campbell M, Knox A, et al. An open study comparing equal doses of budesonide via Turbohaler with fluticasone propionate via Diskhaler in the treatment of adult asthmatic patients. Eur J Clin Res 1997; 9: 185–97

    Google Scholar 

  60. Burdon J, Bish R, Loder M, et al. A comparison of fluticasone propionate 250 µg BD via MDPI and budesonide 600 µg BD via Turbuhaler in adult asthmatics [abstract]. Aust N Z J Med 1997 Apr; 27: 247

    Google Scholar 

  61. Steinmetz K-O. Comparative efficacy and safety of fluticasone propionate MDI versus budesonide powder inhalation in the treatment of moderate asthma [in German]. Atemw Lungenkrkh 1997; 23(12): 730–5

    Google Scholar 

  62. Venables TL, Addlestone MB, Smithers AJ, et al. Acomparison of the efficacy and patient acceptability of once daily budesonide via Turbohaler and twice daily fluticasone propionate via disc-inhaler at an equal daily dose of 400 µg in adult asthmatics. Br J Clin Res 1996; 7: 15–32

    Google Scholar 

  63. Bergmann K-C. Controlled clinical trial of fluticasone propionate dry powder inhaler versus flunisolide metered dose inhaler in patients with mild to moderate asthma [in German]. Pneumologie 1997 Jan; 51: 27–32

    PubMed  CAS  Google Scholar 

  64. Srebro SH, Weber HH, Rogenes PR, et al. Comparison of fluticasone propionate with flunisolide in patients with mild to moderate asthma [abstract no. 27]. J Allergy Clin Immunol 1998 Jan; 101 (1 Pt 2): S6–7

    Google Scholar 

  65. Trautmann M. Efficacy of fluticasone propionate (0.5 mg daily) and flunisolide (1.0 mg daily) in steroid-naive asthmatics [abstract]. Am J Respir Crit Care Med 1995; 151 (4 Pt 2): A275

    Google Scholar 

  66. 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 Oct; 100: 467–74

    Article  PubMed  CAS  Google Scholar 

  67. Gross GN, Wolfe JD, Noonan MJ, et al. Differential effects of inhaled corticosteroids: fluticasone propionate versus triamcinolone acetonide. American J Managed Care 1998; 4(2): 233–44

    Google Scholar 

  68. Boulet LP, Robson R, Stepner N. Clinical equivalence of once vs twice daily administration of inhaled fluticasone propionate in the treatment of mild and moderate asthma [abstract]. Eur Respir J 1996 Sep; 9 Suppl. 23: 52s

    Google Scholar 

  69. Clifford D, Adelglass J, Zu Wallack R, et al. Fluticasone propionate administered via the Diskus 500mcg once daily or 250mcg twice daily is safe and effective in adult patients with asthma [abstract]. Am J Respir Crit Care Med 1997; 155 (4 Pt 2): A349

    Google Scholar 

  70. Kerwin EM, Finn A, Jones R, et al. Once daily treatment of asthma with fluticasone propionate via Diskus: dose response results [abstract no. B37]. American Lung Association/American Thoracic Society 1997 International Conference 1997 May 16–21, San Francisco, CA: 27

  71. Gross GN, Chervinsky P, Gillman S, et al. Low dose inhaled fluticasone propionate once or twice daily via the Diskus is safe and effective in inhaled steroid dependent patients with asthma [abstract no. B37]. American Lung Association/American Thoracic Society 1997 International Conference 1997 May 16–21, San Francisco, CA: 26

  72. Selner J, Boltansky H, Chervinsky P, et al. Low dose inhaled fluticasone propionate administered once daily or twice daily via the Diskus is as safe and effective as beclomethasone dipropionate in steroid naive patients with asthma [abstract]. J Allergy Clin Immunol 1997 Jan; 99 Pt 2: 322

    Google Scholar 

  73. Britton MG, Carrillo T, Almeida J. Combined Serevent and fluticasone propionate (50/100 µg strength) BD via one Diskus (Accuhaler) inhaler compared with salmeterol 50 µg and fluticasone propionate 100 µg BD via two separate Diskus inhalers [abstract]. Am J Respir Crit Care Med 1998 Mar; 157 (Suppl. Pt 2): 415

    Google Scholar 

  74. Ringdal N, Chapman KR, Backer V, et al. Asthma control with salmeterol and fluticasone propionate (50/250 µg) given twice daily in a single combination Diskus (Accuhaler) inhaler compared to salmeterol 50 µg and fluticasone propionate 250 µg given twice daily via 2 separate Diskus inhalers [abstract no. P0330]. Eur Respir J 1998; 12 Suppl. 28: 36s

    Google Scholar 

  75. Gross G, Woodring A, Prillaman B, et al. Efficacy and safety of the salmeterol/fluticasone propionate (50/100 µg) dry powder combination inhaler in patients with asthma [abstract no. P1104]. Eur Respir J 1998; 12 Suppl. 28: 156s

    Google Scholar 

  76. Cook D, Srebro SH, Rogenes PR, et al. A comparison of the safety and efficacy of fluticasone, triamcinolone, and fluticasone plus salmeterol in patients with mild to moderate asthma [abstract]. Am J Respir Crit Care Med 1998 Mar; 157 Suppl. Pt 2: 416

    Google Scholar 

  77. Di Lorenzo G, Polverino M, Ferranti P, et al. Comparison of fluticasone propionate and beclomethasone dipropionate both in combination with salmeterol in patients with moderate asthma [abstract]. Am J Respir Crit Care Med 1997; 155(4): A348

    Google Scholar 

  78. Edwards T, Gross G, Mitchell D, et al. The salmeterol xinafoate/fluticasone propionate dry powder combination product via Diskus inhaler improves asthma control compared to salmeterol xinafoate or fluticasone propionate dry powder alone [abstract]. Am J Respir Crit Care Med 1998 Mar; 157 (Suppl. Pt 2): 414

    Google Scholar 

  79. Ind PW, Dal Negro R, Fletcher CP, et al. Inhaled salmeterol and fluticasone propionate therapy in moderate adult asthma [abstract]. Eur Respir J 1997 Sep; 10 Suppl. 25: 1

    Google Scholar 

  80. Ind PW, Dal Negro R, Colman N, et al. Inhaled fluticasone propionate and salmeterol in moderate adult asthma I: lung function and symptoms. Am J Respir Crit Care Med 1998; 157 (3 Pt 2): A416

    Google Scholar 

  81. Ind PW, DalNegro R, Colman N, et al. Inhaled fluticasone propionate and salmeterol in moderate adult asthma II: exacerbations. Am J Respir Crit Care Med 1998 Mar; 157 (3 Pt 2): A415

    Google Scholar 

  82. Kalberg CJ, Nelson H, Yancey S, et al. A comparison of added salmeterol versus increased-dose fluticasone in patients symptomatic on low-dose fluticasone [abstract]. J Allergy Clin Immunol 1998 Jan; 101 Suppl.: S6

    Google Scholar 

  83. Stricker W, Weinstein S, Chervinsky P, et al. Additive benefits of concurrent salmeterol and fluticasone propionate therapy in asthma [abstract]. J Allergy Clin Immunol 1997 Jan; 99 Pt 2: 319

    Google Scholar 

  84. Juniper EF, Guyatt GH, Ferrie PJ, et al. Measuring quality of life in asthma. Am Rev Respir Dis 1993; 147: 832–8

    PubMed  CAS  Google Scholar 

  85. Juniper EF, Guyatt GH, Willan A, et al. Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol 1994; 47: 81–7

    Article  PubMed  CAS  Google Scholar 

  86. Johansson G, McIvor RA, D’Ambrosio Purello F, et al. Salmeterol/fluticasone propionate combination dry powder inhaler (50/100 µg BID) is more effective than budesonide (400 µg BID) in mild to moderate asthma [abstract]. Eur Respir J 1998; 12 Suppl. 29: 20s

    Google Scholar 

  87. Bowers B, Cox F, Johnson M, et al. Patients receiving inhaled fluticasone propionate 88 mcg bid (FP) report greater improvements in quality of life versus patients receiving zafirlukast 20 mg bid (ZAF) [abstract]. Chest 1998; 114 Suppl. 4: 300s

    Article  Google Scholar 

  88. Johannson L-O. A comparison of once-daily of fluticasone propionate (FP) 200 µg and budesonide (BUD) 400 µg and twice-daily fluticasone propionate (FP) 100 µg. Am J Respir Crit Care Med 1998 Mar; 157 (3 Pt 2): A404

    Google Scholar 

  89. Wiessmann KJ, Trautmann M. Fluticasone propionate (500 mu daily) and flunisolide (1000 mu daily) in the treatment of steroid-naive patients with moderate asthma [abstract]. Eur Respir J 1994; 7 Suppl. 18: 383

    Google Scholar 

  90. Bateman ED, Britton M, Carrillo J, et al. Salmeterol/fluticasone combination inhaler: a new, effective and well tolerated treatment for asthma. Clin Drug Invest 1998 Sep; 16: 193–201

    Article  CAS  Google Scholar 

  91. Weersink EJM, van Zomeren EH, Koeter GH, et al. Treatment of nocturnal airway obstruction improves daytime cognitive performance in asthmatics. Am J Respir Crit Care Med 1997; 156: 1144–50

    PubMed  CAS  Google Scholar 

  92. Reese PR, Mahajan P, Woodring A. Salmeterol/fluticasone propionate combination product improves quality of life in asthma patients [abstract no. P0325]. Eur Respir J 1998; 12 Suppl. 28: 35s

    Google Scholar 

  93. Mahajan P, Davis G, Field E. Asthma-specific quality of life improves following asthma treatment with fluticasone propionate powder 250mcg twice daily or 500mcg once daily [abstract]. Am J Respir Crit Care Med 1997; 155 (4 Pt 2): A349

    Google Scholar 

  94. Lundback B, Dahl R, De JM, et al. A comparison of fluticasone propionate when delivered by either the metered-dose inhaler of the Diskhaler inhaler in the treatment of mild-to-moderate asthma. Eur J Clin Res 1994; 5: 11–9

    Google Scholar 

  95. Pieters WR, Stallaert RALM, Prins J, et al. A study on the clinical equivalence and patient preference of fluticasone propionate 250 µg twice daily via the Diskus/Accuhaler inhaler or the Diskhaler inhaler in adult asthmatic patients. J Asthma 1998; 35(4): 337–45

    Article  PubMed  CAS  Google Scholar 

  96. Mahajan P, Okamoto L. Patient satisfaction with the Diskhaler and the Diskus inhaler, a new multidose powder delivery system for the treatment of asthma. Clin Ther 1997 Sep–Oct; 19: 1126–34

    Article  PubMed  CAS  Google Scholar 

  97. Nielsen K, Okamoto L, Shah T. Importance of selected inhaler characteristics and acceptance of a new breath-actuated powder inhalation device. J Asthma 1997; 34(3): 249–53

    Article  PubMed  CAS  Google Scholar 

  98. Schlaeppi M, Edwards K, Fuller RW, et al. Patient perception of the Diskus inhaler: a comparison with the Turbuhaler inhaler. Br J Clin Pract 1996; 50: 14–9

    PubMed  CAS  Google Scholar 

  99. Backman R, Pickering CAC, Baumgarten C, et al. A comparison of fluticasone propionate via Diskus (Accuhaler) inhaler and budesonide via Turbuhaler inhaler in adult asthmatics [abstract]. J Allergy Clin Immunol 1996 Jan; 97 (Pt 3): 249

    Article  Google Scholar 

  100. Booth P, Capsey L, Langdon C, et al. A comparison of the cost-effectiveness of alternative prophylactic therapies in the treatment of adult asthma. Br J Med Econ 1995; 8: 65–72

    Google Scholar 

  101. Steinmetz K-O, Volmer T, Trautmann M. Cost effectiveness of fluticasone and budesonide in patients with moderate asthma. Clin Drug Invest 1998 Aug; 16: 117–23

    Article  CAS  Google Scholar 

  102. Venables TL, McConchie S, Follows RMA. A comparison of the cost-effectiveness of budesonide and fluticasone dry-powder devices in the management of adult asthma. Br J Med Econ 1996; 10: 315–23

    Google Scholar 

  103. Volmer T, Weber HH, Kielhorn A. Cost-effectiveness of fluticasone propionate and flunisolide in the treatment of moderate asthma [abstract]. Am J Respir Crit Care Med 1998 Mar; 157 (Suppl. Pt 2): 406

    Google Scholar 

  104. Volmer T, Wiessmann KJ, Kielhorn A. Fluticasone propionate vs flunisolide in the treatment of steroid-naive patients with moderate asthma: a cost effectiveness analysis of an open study [abstract]. Am J Respir Crit Care Med 1998 Mar; 157 (3 Pt 2): A408

    Google Scholar 

  105. Inhaled fluticasone propionate prescribing information. Glaxo Wellcome Ltd, Uxbridge, UK. 1998

  106. Laitinen L, Laitinen A, Haahtela T. Airway mucosal inflammation even in patients with newly diagnosed asthma. Am Rev Respir Dis 1993; 147: 697–704

    PubMed  CAS  Google Scholar 

  107. Beasley R, Roche WR, Roberts JA, et al. Cellular events in the bronchi in mild asthma and after bronchial provocation. Am Rev Respir Dis 1989; 139: 806–17

    PubMed  CAS  Google Scholar 

  108. Kirby JG, Hargreave FE, Gleich GJ, et al. Bronchoalveolar cell profiles of asthmatic and nonasthmatic subjects. Am Rev Respir Dis 1987; 136: 379–83

    Article  PubMed  CAS  Google Scholar 

  109. Trigg CJ, Manolitsas ND, Wang J, et al. Placebo-controlled immunopathologic study of four months of inhaled corticosteroids in asthma. Am J Respir Crit Care Med 1994; 150: 17–22

    PubMed  CAS  Google Scholar 

  110. Haahtela T, Järvinen M, Kava T, et al. Comparison of a β2-agonist, terbutaline, with an inhaled corticosteroid, budesonide, in newly detected asthma. N Engl J Med 1991; 325: 388–92

    Article  PubMed  CAS  Google Scholar 

  111. Juniper EF, Kline PA, Vanzieleghem MA, et al. Effect of long-term treatment with an inhaled corticosteroid (budesonide) on airway hyperresponsiveness and clinical asthma in nonsteroid-dependent asthmatics. Am Rev Respir Dis 1990; 142: 832–6

    PubMed  CAS  Google Scholar 

  112. Laitinen LA, Laitinen A, Haahtela T. A comparative study of the effects of an inhaled corticosteroid, budesonide, and a β2-agonist, terbutaline, on airway inflammation in newly diagnosed asthma: a randomized, double-blind, parallel-group controlled trial. J Allergy Clin Immunol 1992; 90: 32–42

    Article  PubMed  CAS  Google Scholar 

  113. Selroos O, Pietinalho A, Löfroos A-B, et al. Effect of early vs late intervention with inhaled corticosteroids in asthma. Chest 1995; 108: 1228–34

    Article  PubMed  CAS  Google Scholar 

  114. Haahtela T, Järvinen M, Kava T, et al. Effects of reducing or discontinuing inhaled budesonide in patients with mild asthma. N Engl J Med 1994; 331: 700–5

    Article  PubMed  CAS  Google Scholar 

  115. Blais L, Suissa S, Boivin J-F, et al. First treatment with inhaled corticosteroids and the prevention of admissions to hospital for asthma. Thorax 1998; 53: 1025–9

    Article  PubMed  CAS  Google Scholar 

  116. Jatulis DE, Meng Y-Y, Elashoff RM, et al. Preventive pharmacologic therapy among asthmatics: five years after publication of guidelines. Ann Allergy Asthma Immunol 1998; 81: 82–8

    Article  PubMed  CAS  Google Scholar 

  117. Kaur B, Anderson HR, Austin J, et al. Prevalence of asthma symptoms, diagnosis, and treatment in 12–14 year old children across Great Britain (international study of asthma and allergies in childhood, ISAAC UK). BMJ 1998; 316: 118–24

    Article  PubMed  CAS  Google Scholar 

  118. Bousquet J, Knani J, Henry C, et al. Undertreatment in a non-selected population of adult patients with asthma. J Allergy Clin Immunol 1996 Sep; 98: 514–21

    Article  PubMed  CAS  Google Scholar 

  119. Lang DM, Sherman MS, Polansky M. Guidelines and realities of asthma management: the Philadelphia story. Arch Intern Med 1997 Jun 9; 157: 1193–200

    Article  PubMed  CAS  Google Scholar 

  120. Ferrante E, Muzzolon R, Fuso L, et al. Bronchial asthma: still an inadequately assessed and improperly treated disease. J Asthma 1994; 31: 117–21

    Article  PubMed  CAS  Google Scholar 

  121. Gaist D, Hallas J, Hansen N-CG, et al. Are young adults with asthma treated sufficiently with inhaled steroids? A population-based study of prescription data from 1991 and 1994. Br J Clin Pharmacol 1996; 41: 285–9

    Article  PubMed  CAS  Google Scholar 

  122. Donahue JG, Weiss ST, Livingston JM, et al. Inhaled steroids and the risk of hospitalization for asthma. JAMA 1997; 277: 887–91

    Article  PubMed  CAS  Google Scholar 

  123. Van Ganse E, Hubloue I, Vincken W, et al. Actual use of inhaled corticosteroids and risk of hospitalisation: a case-control study. Eur J Clin Pharmacol 1997; 51: 449–54

    Article  PubMed  Google Scholar 

  124. Griffiths C, Naish J, Sturdy P, et al. Prescribing and hospital admissions for asthma in east London. BMJ 1996; 312: 481–2

    Article  PubMed  CAS  Google Scholar 

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Jarvis, B., Faulds, D. Inhaled Fluticasone Propionate. Drugs 57, 769–803 (1999). https://doi.org/10.2165/00003495-199957050-00016

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