Am. J. Respir. Crit. Care Med., Volume 156, Number 3, September 1997, 744-751

Efficacy of Inhaled Fluticasone Propionate in Asthma Results from Topical and Not from Systemic Activity

MICHAEL LAWRENCE, JAMES WOLFE, D. ROBERT WEBB, PAUL CHERVINSKY, DONALD KELLERMAN, JOHN P. SCHAUMBERG, and TUSHAR SHAH

Asthma and Allergy Physicians, Taunton, Massachusetts; Allergy and Asthma Associates of Santa Clara Valley, San Jose, California; Allergy and Asthma Center, North Dartmouth, Massachusetts; Glaxo Wellcome Inc., Research Triangle Park, North Carolina

The objective of this study was to determine whether the therapeutic benefits of inhaled fluticasone propionate are mediated through topical or systemic effects. Two hundred seventy-four patients with asthma receiving beclomethasone dipropionate or triamcinolone acetonide during a 2-wk, single-blind, run-in period were randomized to inhaled fluticasone propionate powder 100 or 500 µg twice daily, oral fluticasone propionate 20 mg once daily, or placebo during a 6-wk treatment period. Patients receiving inhaled fluticasone propionate had a significantly greater probability of remaining in the study over time compared with patients receiving oral fluticasone propionate or placebo (p = 0.001). FEV₁ and PEF rates at end point were significantly higher with inhaled fluticasone propionate treatment regimens than with oral fluticasone propionate (with the exception of PEF rates for inhaled fluticasone propionate 100 µg) or placebo treatments (p  0.004). Systemic exposure to fluticasone propionate as assessed by trough plasma concentrations and/or 12-hr plasma concentration area under the curve analyses (AUC₁₂) was higher with the oral fluticasone propionate than with the two inhaled fluticasone propionate treatment groups. The results of this study suggest that the therapeutic benefits of inhaled fluticasone propionate are mediated through topical effects in the lungs and not through systemic effects.

This article has been cited by other articles:

				C. M. Roller, G. Zhang, R. G. Troedson, C. L. Leach, P. N. Le Souef, and S. G. Devadason Spacer inhalation technique and deposition of extrafine aerosol in asthmatic children Eur. Respir. J., February 1, 2007; 29(2): 299 - 306. [Abstract] [Full Text] [PDF]

				G. L. Colice Categorizing Asthma Severity: An Overview of National Guidelines Clin. Med. Res., August 1, 2004; 2(3): 155 - 163. [Abstract] [Full Text] [PDF]

				B. Luijk, R.D. Kempsford, A.M. Wright, P. Zanen, and J-W.J. Lammers Duration of effect of single-dose inhaled fluticasone propionate on AMP-induced bronchoconstriction Eur. Respir. J., April 1, 2004; 23(4): 559 - 564. [Abstract] [Full Text] [PDF]

				M Masoli, M Weatherall, S Holt, and R Beasley Clinical dose-response relationship of fluticasone propionate in adults with asthma Thorax, January 1, 2004; 59(1): 16 - 20. [Abstract] [Full Text] [PDF]

				R J Meijer, D S Postma, and H A M Kerstjens Conventional RIA underestimates cortisol suppression in the presence of prednisolone Thorax, April 1, 2002; 57(4): 374 - 374. [Full Text] [PDF]

				S. Holt, A. Suder, M. Weatherall, S. Cheng, P. Shirtcliffe, R. Beasley, and A. Herxheimer Dose-response relation of inhaled fluticasone propionate in adolescents and adults with asthma: meta-analysis Commentary: Dosage needs systematic and critical review BMJ, August 4, 2001; 323(7307): 253 - 253. [Abstract] [Full Text] [PDF]

				B. J. Lipworth, R. A. Nathan, and R. ZuWallack Fluticasone and Cortisol Measurements Chest, March 1, 2001; 119(3): 984 - 985. [Full Text] [PDF]

				R J Meijer, H A M Kerstjens, L R Arends, H F Kauffman, G H Koëter, and D S Postma Effects of inhaled fluticasone and oral prednisolone on clinical and inflammatory parameters in patients with asthma Thorax, October 1, 1999; 54(10): 894 - 899. [Abstract] [Full Text]