Concurrent use of intranasal and orally inhaled fluticasone propionate does not affect hypothalamic-pituitary-adrenal, axis function

Two double-blind, randomized, placebo-controlled, parallel group safety and efficacy studies included evaluation of the hypothalmic-pituitary-adrenal (HPA)-axis effects of concurrent treatment with intranasal and orally inhaled fluticasone propionate (FP). In the first study, patients with asthma who were greater than or equal to12 Years of age were assigned randomly to receive twice-daily doses (either 88 or 220 mug) of orally inhaled FP delivered from a metered-dose inhaler (MDI). In the second study, patients were assigned randomly: to receive either orally inhaled FP 250 mug or orally inhaled FP 250 mug/salmeterol 50 mug delivered via the Diskus device. In both studies. patients with rhinitis were allowed to continue the use Of intranasal FP at their usual dosing. Treatment periods were 26 weeks and 12 weeks for the MDI and Diskus studies, respectively HPA-axis effects were assessed using response to short cosyntropin stimulation testing. The number and percentage of patients with an abnormal cortisol response, defined as a morning plasma cortisol of <5 mu g/dL, a poststimulation peak of <18 mug/dL, or a poststimulation rise of <7 mu g/dL, were summarized in two subgroups: patients who used intranasal FP and those who did not. The concurrent administration of intranasal FP and orally inhaled FP via an MDI or Diskus or via Diskus with salmeterol was not associated with HPA-axis effects compared with orally inhaled FP alone. The results of these two studies suggest that concurrent use of intranasal FP with orally inhaled FP administered via MDI or Diskus for treatment of comorbid rhinitis and asthma does not increase the risk of HPA-axis abnormalities.