Systemic bioavailability of hydrofluoroalkane (HFA) formulations of fluticasone/salmeterol in healthy volunteers via pMDI alone and spacer

British Journal of Clinical Pharmacology

Volumn 69, Issue 6, 2010, Pages 637-644

  Clearie, Karine L ^a   Williamson, Peter A ^a   Vaidyanathan, Sriram ^a   Du Bois, Jeannine ^b   Nell, Haylene ^c   Lipworth, Brian J ^a  

^a UNIVERSITY OF DUNDEE   (United Kingdom)

^b Karl Bremer Hospital   (South Africa)

^c 47 Grens Street   (South Africa)

Author keywords

Fluticasone; HFA; Pharmacokinetics; Salmeterol

Indexed keywords

CREATININE; FLUORINATED HYDROCARBON; FLUTICASONE PROPIONATE PLUS SALMETEROL; HYDROCORTISONE; POTASSIUM; POTASSIUM CHLORIDE;

ADRENAL SUPPRESSION; ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEVICE; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG ACTIVITY; DRUG BIOAVAILABILITY; DRUG FORMULATION; FEMALE; HUMAN; HYDROCORTISONE URINE LEVEL; HYPOKALEMIA; IN VITRO STUDY; MALE; METERED DOSE INHALER; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINGLE DRUG DOSE;

ADMINISTRATION, INHALATION; ADULT; ALBUTEROL; ANDROSTADIENES; ANTI-ASTHMATIC AGENTS; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CREATININE; CROSS-OVER STUDIES; DRUG COMBINATIONS; FEMALE; GLUCOCORTICOIDS; HUMANS; HYDROCARBONS, FLUORINATED; HYDROCORTISONE; MALE; METERED DOSE INHALERS; POTASSIUM; YOUNG ADULT;

EID: 77952052809     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2010.03655.x     Document Type: Article

References (19)

1. Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA). From the Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA). 2007. Available at http://www.ginasthma.org (last accessed M. Moderate dose inhaled corticosteroids plus salmeterol versus higher doses of inhaled corticosteroids in symptomatic asthma. Thorax 2005 60 : 730 734.
2. Woolcock A, Lundback B, Ringdal N, Jacques LA. Comparison of addition of salmeterol to inhaled steroids with doubling of the dose of inhaled steroids. Am J Respir Crit Care Med 1996 153 : 1481 1488. (Pubitemid 26141329)
3. Nelson HS, Chapman KR, Pyke SD, Johnson M, Pritchard JN. Enhanced synergy between fluticasone propionate and salmeterol inhaled from a single inhaler versus separate inhalers. J Allergy Clin Immunol 2003 112 : 29 36. (Pubitemid 36819803)
4. Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma Control study. Am J Respir Crit Care Med 2004 170 : 836 844. (Pubitemid 39346477)
5. Busse W, Koenig SM, Oppenheimer J, Sahn SA, Yancey SW, Reilly D, Edwards LD, Dorinsky PM. Steroid-sparing effects of fluticasone propionate 100 ug and salmeterol 50 ug administered twice daily in a single product in patients previously controlled with fluticasone propionate 250 ug administered twice daily. J Allergy Clin Immunol 2003 111 : 57 65. (Pubitemid 36143292)
6. Van den Berg NJ, Ossip MS, Hederos CA, Anttila H, Ribeiro BL, Davies PI. Salmeterol/fluticasone propionate (50/100 microg) in combination in a Diskus inhaler (Seretide) is effective and safe in children with asthma. Pediatr Pulmonol 2000 30 : 97 105.
7. Dempsey OJ, Wilson AM, Coutie WJR, Lipworth BJ. Evaluation of the effect of a large volume spacer on the systemic bioactivity of fluticasone propionate metered-dose inhaler. Chest 1999 116 : 935 940.
8. Dempsey OJ, Coutie WJR, Wilson AM, Williams P, Lipworth BJ. Evaluation of the buccal component of systemic absorption with inhaled fluticasone propionate. Thorax 1999 54 : 614 617. (Pubitemid 29296682)
9. Thorsson L, Dahlstrom K, Edsbacker S, Kallen A, Paulson J, Wiren JE. Pharmacokinetics and systemic effects of inhaled fluticasone propionate in healthy subjects. Br J Clin Pharmacol 1997 43 : 155 161. (Pubitemid 27085366)
10. Bennett JA, Harrison TW, Tattersfield AE. The contribution of the swallowed fraction of an inhaled dose of salmeterol to it systemic effects. Eur Respir J 1999 13 : 445 448. (Pubitemid 29086848)
11. Kempsford R, Handel M, Mehta R, De Silva M, Daley-Yates P. Comparison of the systemic pharmacodynamic effects and pharmacokinetics of salmeterol delivered by CFC propellant and non-CFC propellant metered dose inhalers in healthy subjects. Respir Med 2005 99 (Suppl. A S11 9. (Pubitemid 40353085)
12. Lipworth BJ. Adrenal suppression with inhaled corticosteroid. Ann Allergy Asthma Immunol 2001 87 : 359 361.
13. Nair A, Clearie K, Menzies D, Meldrum K, McFarlane L, Lipworth BJ. A novel breath-actuated integrated vortex spacer device increases relative lung bioavailability of fluticasone/salmeterol in combination. Pulm Pharmacol Ther 2009 22 : 305 310.
14. Wilson AM, Sims EJ, Lipworth BJ. Dose-response with fluticasone propionate on adrenocortical activity and recovery of basal and stimulated responses after stopping treatment. Clin Endocrinol 1999 50 : 329 335.
15. Newnham DM, McDevitt DG, Lipworth BJ. Bronchodilator subsensitivity after chronic dosing with eformoterol in patients with asthma. Am J Med 1994 97 : 29 37.
16. 2 adrenoceptor responses after regular twice daily treatment with eformoterol dry powder in asthmatic patients. Thorax 1995 50 : 497 504.
17. Tan KS, Grove A, McLean A, Gnosspelius Y, Hall IP, Lipworth BJ. Systemic corticosteriod rapidly reverses bronchodilator subsensitivity induced by formoterol in asthmatic patients. Am J Respir Crit Care Med 1997 156 : 28 35. (Pubitemid 27293163)
18. Grove A, Lipworth BJ. Bronchodilator subsensitivity to salbutamol after twice daily salmeterol in asthmatic patients. Lancet 1995 346 : 201 206.
19. 2-adrenoceptor-mediated responses to inhaled salbutamol. Br J Clin Pharmacol 2001 51 : 359 362. (Pubitemid 32391493)