Abstract
BACKGROUND--Fluticasone propionate is a new inhaled corticosteroid with a 2:1 efficacy ratio compared with beclomethasone dipropionate with regard to lung function and symptom scores, without increased systemic activity. The aim of this study was to investigate whether this was also the case for bronchial hyperresponsiveness, assessed by both a direct (histamine) and an indirect (ultrasonically nebulised distilled water (UNDW)) provocation test. METHODS--Fluticasone propionate, 750 micrograms/day, and beclomethasone dipropionate, 1500 micrograms/day, were compared in a randomised, double blind, crossover study consisting of two six week treatment periods, each preceded by a three week single blind placebo period. Twenty one non-smoking asthmatics (mean forced expiratory volume in one second (FEV1) 74.7% predicted, mean PC20histamine 0.36 mg/ml) completed the study. RESULTS--Fluticasone propionate and beclomethasone dipropionate improved FEV1, peak flow rates, asthma symptoms, and bronchial hyperresponsiveness to the same extent. Both fluticasone propionate and beclomethasone dipropionate caused an increase in PC20histamine (mean 2.29 [95% confidence interval 1.45 to 3.13] and 1.95 [1.07 to 2.84] doubling doses, respectively) and in PD20UNDW (1.12 [0.55 to 1.70] and 1.28 [0.88 to 1.70] doubling doses, respectively). Neither treatment changed morning serum cortisol levels, but fluticasone propionate decreased the number of peripheral blood eosinophils less than beclomethasone dipropionate, indicating smaller systemic effects of fluticasone propionate. CONCLUSIONS--These findings show that fluticasone propionate is as effective as twice the dose of beclomethasone dipropionate on bronchial hyperresponsiveness, assessed by provocation with both histamine and UNDW, without increased systemic activity.
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- Anderson S. D., Smith C. M. Osmotic challenges in the assessment of bronchial hyperresponsiveness. Am Rev Respir Dis. 1991 Mar;143(3 Pt 2):S43–S46. doi: 10.1164/ajrccm/143.3_Pt_2.S43. [DOI] [PubMed] [Google Scholar]
- Ayres J. G., Bateman E. D., Lundbäck B., Harris T. A. High dose fluticasone propionate, 1 mg daily, versus fluticasone propionate, 2 mg daily, or budesonide, 1.6 mg daily, in patients with chronic severe asthma. International Study Group. Eur Respir J. 1995 Apr;8(4):579–586. [PubMed] [Google Scholar]
- Barnes N. C., Marone G., Di Maria G. U., Visser S., Utama I., Payne S. L. A comparison of fluticasone propionate, 1 mg daily, with beclomethasone dipropionate, 2 mg daily, in the treatment of severe asthma. International Study Group. Eur Respir J. 1993 Jun;6(6):877–885. [PubMed] [Google Scholar]
- Barnes P. J., Pedersen S. Efficacy and safety of inhaled corticosteroids in asthma. Report of a workshop held in Eze, France, October 1992. Am Rev Respir Dis. 1993 Oct;148(4 Pt 2):S1–26. doi: 10.1164/ajrccm/148.4_Pt_2.S1. [DOI] [PubMed] [Google Scholar]
- Bland J. M., Altman D. G. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307–310. [PubMed] [Google Scholar]
- Cockcroft D. W., Killian D. N., Mellon J. J., Hargreave F. E. Bronchial reactivity to inhaled histamine: a method and clinical survey. Clin Allergy. 1977 May;7(3):235–243. doi: 10.1111/j.1365-2222.1977.tb01448.x. [DOI] [PubMed] [Google Scholar]
- Dahl R., Lundback B., Malo J. L., Mazza J. A., Nieminen M. M., Saarelainen P., Barnacle H. A dose-ranging study of fluticasone propionate in adult patients with moderate asthma. International Study Group. Chest. 1993 Nov;104(5):1352–1358. doi: 10.1378/chest.104.5.1352. [DOI] [PubMed] [Google Scholar]
- Fabbri L., Burge P. S., Croonenborgh L., Warlies F., Weeke B., Ciaccia A., Parker C. Comparison of fluticasone propionate with beclomethasone dipropionate in moderate to severe asthma treated for one year. International Study Group. Thorax. 1993 Aug;48(8):817–823. doi: 10.1136/thx.48.8.817. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Groot C. A., Lammers J. W., Molema J., Festen J., van Herwaarden C. L. Effect of inhaled beclomethasone and nedocromil sodium on bronchial hyperresponsiveness to histamine and distilled water. Eur Respir J. 1992 Oct;5(9):1075–1082. [PubMed] [Google Scholar]
- Groot C., Lammers J. W., Festen J., van Herwaarden C. Refractoriness for ultrasonically nebulized distilled water and histamine after histamine challenge. J Appl Physiol (1985) 1991 Mar;70(3):1011–1015. doi: 10.1152/jappl.1991.70.3.1011. [DOI] [PubMed] [Google Scholar]
- Harding S. M. The human pharmacology of fluticasone propionate. Respir Med. 1990 Nov;84 (Suppl A):25–29. doi: 10.1016/s0954-6111(08)80004-2. [DOI] [PubMed] [Google Scholar]
- Higgins B. G., Britton J. R., Chinn S., Jones T. D., Jenkinson D., Burney P. G., Tattersfield A. E. The distribution of peak expiratory flow variability in a population sample. Am Rev Respir Dis. 1989 Nov;140(5):1368–1372. doi: 10.1164/ajrccm/140.5.1368. [DOI] [PubMed] [Google Scholar]
- Holliday S. M., Faulds D., Sorkin E. M. Inhaled fluticasone propionate. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in asthma. Drugs. 1994 Feb;47(2):318–331. doi: 10.2165/00003495-199447020-00007. [DOI] [PubMed] [Google Scholar]
- Juniper E. F., Kline P. A., Vanzieleghem M. A., Hargreave F. E. Reduction of budesonide after a year of increased use: a randomized controlled trial to evaluate whether improvements in airway responsiveness and clinical asthma are maintained. J Allergy Clin Immunol. 1991 Feb;87(2):483–489. doi: 10.1016/0091-6749(91)90006-a. [DOI] [PubMed] [Google Scholar]
- Leblanc P., Mink S., Keistinen T., Saarelainen P. A., Ringdal N., Payne S. L. A comparison of fluticasone propionate 200 micrograms/day with beclomethasone dipropionate 400 micrograms/day in adult asthma. Allergy. 1994 May;49(5):380–385. doi: 10.1111/j.1398-9995.1994.tb02286.x. [DOI] [PubMed] [Google Scholar]
- Mattoli S., Foresi A., Corbo G. M., Valente S., Patalano F., Ciappi G. Increase in bronchial responsiveness to methacholine and late asthmatic response after the inhalation of ultrasonically nebulized distilled water. Chest. 1986 Nov;90(5):726–732. doi: 10.1378/chest.90.5.726. [DOI] [PubMed] [Google Scholar]
- Meulenberg P. M., Ross H. A., Swinkels L. M., Benraad T. J. The effect of oral contraceptives on plasma-free and salivary cortisol and cortisone. Clin Chim Acta. 1987 Jun 15;165(2-3):379–385. doi: 10.1016/0009-8981(87)90183-5. [DOI] [PubMed] [Google Scholar]
- Nicolaizik W. H., Marchant J. L., Preece M. A., Warner J. O. Endocrine and lung function in asthmatic children on inhaled corticosteroids. Am J Respir Crit Care Med. 1994 Sep;150(3):624–628. doi: 10.1164/ajrccm.150.3.8087329. [DOI] [PubMed] [Google Scholar]
- O'Connor B. J., Ridge S. M., Barnes P. J., Fuller R. W. Greater effect of inhaled budesonide on adenosine 5'-monophosphate-induced than on sodium-metabisulfite-induced bronchoconstriction in asthma. Am Rev Respir Dis. 1992 Sep;146(3):560–564. doi: 10.1164/ajrccm/146.3.560. [DOI] [PubMed] [Google Scholar]
- O'Shaughnessy K. M., Wellings R., Gillies B., Fuller R. W. Differential effects of fluticasone propionate on allergen-evoked bronchoconstriction and increased urinary leukotriene E4 excretion. Am Rev Respir Dis. 1993 Jun;147(6 Pt 1):1472–1476. doi: 10.1164/ajrccm/147.6_Pt_1.1472. [DOI] [PubMed] [Google Scholar]
- Oosterhoff Y., Koëter G. H., De Monchy J. G., Postma D. S. Circadian variation in airway responsiveness to methacholine, propranolol, and AMP in atopic asthmatic subjects. Am Rev Respir Dis. 1993 Mar;147(3):512–517. doi: 10.1164/ajrccm/147.3.512. [DOI] [PubMed] [Google Scholar]
- Pauwels R., Joos G., Van der Straeten M. Bronchial hyperresponsiveness is not bronchial hyperresponsiveness is not bronchial asthma. Clin Allergy. 1988 Jul;18(4):317–321. doi: 10.1111/j.1365-2222.1988.tb02878.x. [DOI] [PubMed] [Google Scholar]
- Stark R. D. Dyspnoea: assessment and pharmacological manipulation. Eur Respir J. 1988 Mar;1(3):280–287. [PubMed] [Google Scholar]
- Toogood J. H., Baskerville J. C., Jennings B., Lefcoe N. M., Johansson S. A. Influence of dosing frequency and schedule on the response of chronic asthmatics to the aerosol steroid, budesonide. J Allergy Clin Immunol. 1982 Oct;70(4):288–298. doi: 10.1016/0091-6749(82)90065-3. [DOI] [PubMed] [Google Scholar]
- Vathenen A. S., Knox A. J., Wisniewski A., Tattersfield A. E. Time course of change in bronchial reactivity with an inhaled corticosteroid in asthma. Am Rev Respir Dis. 1991 Jun;143(6):1317–1321. doi: 10.1164/ajrccm/143.6.1317. [DOI] [PubMed] [Google Scholar]