ICS Systemic Effects: HPA Axis

• FLTA3025: Serum Cortisol AUC12 + PK (4 wks)

  • FP 250 ?g BID: ?10% vs. placebo
  • FP 500 ?g BID: ?21% vs. placebo

• SFCA3006, 3007: ACTH stimulation testing in a subset

• ISOLDE (FLTA78): AM Cortisol

  • FP 500 ?g BID X 36 months: ?10-15% mean AM Cortisol for FP vs. placebo at all time-points (pɘ.01)
  • 20% FP had Cortisol “shift” from N to L (9% placebo)

• FLTA1003 (PK/PD study): Urinary Cortisol

  • Single dose, crossover, normals
  • FP 1000 ?g single dose: ? 35% - 59% vs. pre-dose

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