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Advair Inhalers Safe in a Twice-Daily Regimen for Adult Asthmatics: Presented at ACCP
By Maria Bishop
BOSTON, MA -- September 18, 2006 -- The combination of inhaled fluticasone propionate and salmeterol (Advair) appears to be safe for adults with asthma who require a twice-daily regimen, according to investigators speaking here at the American College of Clinical Pharmacology 35th Annual Meeting (ACCP).
Thirteen adult asthmatics completed a randomized, double-blind, placebo-controlled, repeat-dose, 4-way crossover study comparing the pharmacokinetics and systemic pharmacodynamics of fluticasone and salmeterol for 4 weeks.
Systemic exposure to fluticasone propionate from Advair DISKUS (a combination fluticasone propionate and salmeterol dry-powder inhaler) and Advair metered-dose inhaler (a formulation of the 2 drugs administered by hydrofluoroalkane [HFA] propellant) was similar and did not affect serum cortisol levels at therapeutic doses (250/50 mcg twice daily for the DISKUS and 125/25 mcg twice daily for the metered-dose inhaler). By comparison, fluticasone systemic exposure from a similar drug--Flovent HFA metered-dose inhaler (2 inhalations of 125 mcg twice daily)--was lower than exposure from the Advair inhalers, and also did not affect serum cortisol.
Salmeterol systemic exposure was again similar in the Advair DISKUS and metered-dose-inhaler groups, and did not produce any significant increases in heart rate or QTc interval assessments compared with placebo, said lead investigator Rashmi Mehta, senior pharmacokineticist, GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina.
No correlations were found between fluticasone propionate and salmeterol pharmacodynamic effects and exposure, and both treatments were well tolerated, with no serious adverse effects observed in the twice-daily regimen.
The researchers concluded that the repeat-dose regimen used in this study appears safe for use by adult asthmatics.
[Presentation title: Pharmacokinetics and Pharmacodynamics of Inhaled Advair (Fluticasone Propionate/Salmeterol) DISKUS and Metered-Dose Inhalers in Adult Patients with Asthma. Abstract 38]
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