Lack of Significant Systemic Activity With Flunisolide HFA (Aerospan) in Adults and Adolescent Asthmatics.

SESSION TITLE: Asthma Posters ISESSION TYPE: Original Investigation PosterPRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PMPURPOSE: Negative systemic effects (including HPA-axis suppression, cataract formation/glaucoma, and increased bone metabolism) have been seen with higher doses of inhaled steroids in adult patients. A 12-week trial performed with flunisolide HFA (Aerospan™; a new, small-particle inhaled steroid with a built-in spacer for asthma) included various assessments for potential systemic effects.

METHODS: In a double-blind, placebo-controlled 12-week trial in adult and adolescent patients 12 years and older, asthmatic patients were treated with: placebo, flunisolide HFA (80 mcg, 160 mcg or 320 mcg BID) or flunisolide CFC (250 mcg, 500 mcg or 100 mcg BID). Various assessments of potential systemic effects of flunisolide HFA were performed in this trial, including: HPA-axis function (24-hr urine cortisol and creatinine, plasma cortisol and cosyntropin stimulation tests), serum osteocalcin, clinical laboratory (evaluating shifts in various related assessments, including-white blood cell counts and glucose levels) and physical examinations (including eyes, ears, nose and throat).

RESULTS: Urinary and plasma cortisol results were similar between placebo and each of the doses of flunisolide HFA (up to 320 mcg BID). Mean values for hematology assessments performed (including white blood cell counts) were all within normal ranges. The number of clinically significant abnormal chemistry test results (including changes in glucose, calcium, alkaline phosphatase and phosphate levels) and changes in physical examination findings were also similar between the placebo and flunisolide HFA treatment groups. Changes in serum osteocalcin levels for those treated with flunisolide HFA were similar to those for placebo.

CONCLUSIONS: After 12 weeks of treatment, doses of flunisolide HFA up to 320 mcg BID (maximum approved dose) did not result in any significant (negative) systemic effects.

CLINICAL IMPLICATIONS: Flunisolide HFA has a limited potential for significant systemic effects (due to its favorable metabolic profile), allowing for chronic use in asthmatics down to the age of 6 years.

DISCLOSURE: William Berger: Consultant fee, speaker bureau, advisory committee, etc.: Consultant for Meda Pharmaceuticals John Karafilidis: Employee: Employee Meda Pharmaceuticals Larry Gever: Employee: Meda Pharmaceuticals Employee Nancy Ruiz: Employee: Meda Pharmaceuticals EmployeeNo Product/Research Disclosure Information.