PT  - JOURNAL ARTICLE
AU  - Michael Tamm
AU  - Kirsten Kaiser
AU  - Brigit Grothe
AU  - Mark Lomax
TI  - Effects on adrenal function of a new combination of fluticasone propionate/formoterol fumarate administered to asthmatic patients and healthy subjects
DP  - 2011 Sep 01
TA  - European Respiratory Journal
PG  - p4010
VI  - 38
IP  - Suppl 55
4099  - http://erj.ersjournals.com/content/38/Suppl_55/p4010.short
4100  - http://erj.ersjournals.com/content/38/Suppl_55/p4010.full
SO  - Eur Respir J2011 Sep 01; 38
AB  - Background: Corticosteroid treatment is known to affect adrenal function via suppression of the hypothalamic-pituitary-adrenal axis. This effect was assessed for a new asthma therapy combining the corticosteroid fluticasone (FLUT) with formoterol (FORM) in a single aerosol inhaler (FLUT/FORM; flutiform®).Methods: Healthy subjects and patients with mild to severe asthma were treated for 4 to 12 weeks with FLUT/FORM (100/10μg, 250/10μg, or 500/20μg b.i.d.) in 3 randomised, parallel-group studies comparing FLUT/FORM with FLUT, FLUT+FORM from separate inhalers, or placebo. The endpoints were changes in urinary and serum cortisol levels from baseline to end of study.Results: No significant differences were observed in mean urinary cortisol levels with FLUT/FORM 100/10μg (N=38; mean 21.51μg/24h; p=0.733) or FLUT/FORM 250/10μg (N=40; mean 24.01μg/24h; p=0.510) compared with placebo (N=39; mean 21.95μg/24h). In a study using FLUT/FORM 100/10μg or 250/10μg, patients had similar mean urinary cortisol levels at baseline and end of study (N=27; 5.1 vs 6.0nmol/L). The corresponding mean serum cortisol levels were 372.9 vs 412.6nmol/L (N=104). Healthy subjects given FLUT/FORM 500/20μg had a decrease in both urinary and serum cortisol levels at end of study but this was less than with FLUT 500μg+FORM 24μg (urinary: N=24; 13 to 7nmol/24h vs 14 to 4nmol/24h; serum: N=24; 399 to 272nmol/L vs 430 to 154nmol/L).Conclusions: Fluticasone/formoterol 100/10μg or 250/10μg showed no significant changes in urinary or serum cortisol levels. Fluticasone/formoterol 500/20μg had some effect on adrenal function but less than FLUT+FORM given at the same nominal dose.