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Efficacy and Safety of Flunisolide HFA (Aerospan) in Asthma Across Various Subgroups
October 2014, Vol 146, No. 4_MeetingAbstracts
Allergy and Airway | October 2014
Efficacy and Safety of Flunisolide HFA (Aerospan) in Asthma Across Various Subgroups John Karafilidis; William Berger, MBA; Larry Gever, PharmD; Nancy Ruiz, MD MEDA Pharmaceuticals, Somerset, NJ
Chest. 2014;146(4_MeetingAbstracts):4A. doi:10.1378/chest.1990469
Abstract SESSION TITLE: Asthma Posters I SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM PURPOSE: In two, 12-week, double-blind, placebo- and active-controlled pivotal trials in asthmatic patients with flunisolide HFA (Aerospan™, a smallparticle ICS with a built-in spacer to optimize delivery of flunisolide HFA throughout the lung, while minimizing oral deposition). In these trials, various subgroup analyses were performed based on demographic parameters and asthma severity. METHODS: Efficacy and safety of flunisolide HFA doses of: 80 mcg (1 puff) BID, 160 (2 puffs) mcg BID and 320 mcg (4 puffs) BID in adults/adolescents 12 years and older and 80 (1 puff) and 160 (2 puffs) mcg BID in pediatric patients 4 years and older were evaluated. Specifically, sub-group evaluations based on demographics (age-4-5 years, 6-11 years, 12-17 years, greater than 18 years, gender and race) and asthma disease severity (percent predicted FEV1 less than population median of 73.9% in adult/adolescent trial and 83.3% predicted FEV1 in the pediatric 4-11 trial compared with those with percent predicted FEV1 greater than or equal to the population median).
RESULTS: Deterioration of percent predicted FEV1 from baseline was observed in the placebo group, whereas minimal changes or improvements were observed in the flunisolide HFA groups after being switched from 2 weeks of flunisolide CFC (500 mcg BID) during a 2-week run-in. No significant changes in percent predicted FEV1 were noted for other sub-groups analyzed (based on gender, race, or asthma severity). Flunisolide HFA did not increase the incidence of any treatment-emergent adverse events (TEAEs) by age, gender, race, or baseline asthma severity, either within the flunisolide HFA treatment groups or by comparison to placebo. CONCLUSIONS: Treatment with Aerospan was efficacious and safe across the entire age range of patients and across subpopulations determined by gender, race, and disease severity.
CLINICAL IMPLICATIONS: The unique properties of flunisolide HFA, with its small particle size and built-in spacer, offer an advanced treatment option for asthmatics. The flunisolide HFA product attributes may be particularly beneficial for pediatric patients. DISCLOSURE: John Karafilidis: Employee: Meda Pharmaceutical Employee William Berger: Consultant fee, speaker bureau, advisory committee, etc.: Meda Pharmaceutical Consultant Larry Gever: Employee: Meda Pharmaceutical Employee Nancy Ruiz: Employee: Meda Pharmaceutical Employee No Product/Research Disclosure Information
Allergy and Airway | October 2014
Efficacy and Safety of Flunisolide HFA (Aerospan) in Asthma Across Various Subgroups John Karafilidis; William Berger, MBA; Larry Gever, PharmD; Nancy Ruiz, MD MEDA Pharmaceuticals, Somerset, NJ
Chest. 2014;146(4_MeetingAbstracts):4A. doi:10.1378/chest.1990469
Abstract SESSION TITLE: Asthma Posters I SESSION TYPE: Original Investigation Poster PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM PURPOSE: In two, 12-week, double-blind, placebo- and active-controlled pivotal trials in asthmatic patients with flunisolide HFA (Aerospan™, a smallparticle ICS with a built-in spacer to optimize delivery of flunisolide HFA throughout the lung, while minimizing oral deposition). In these trials, various subgroup analyses were performed based on demographic parameters and asthma severity. METHODS: Efficacy and safety of flunisolide HFA doses of: 80 mcg (1 puff) BID, 160 (2 puffs) mcg BID and 320 mcg (4 puffs) BID in adults/adolescents 12 years and older and 80 (1 puff) and 160 (2 puffs) mcg BID in pediatric patients 4 years and older were evaluated. Specifically, sub-group evaluations based on demographics (age-4-5 years, 6-11 years, 12-17 years, greater than 18 years, gender and race) and asthma disease severity (percent predicted FEV1 less than population median of 73.9% in adult/adolescent trial and 83.3% predicted FEV1 in the pediatric 4-11 trial compared with those with percent predicted FEV1 greater than or equal to the population median).
RESULTS: Deterioration of percent predicted FEV1 from baseline was observed in the placebo group, whereas minimal changes or improvements were observed in the flunisolide HFA groups after being switched from 2 weeks of flunisolide CFC (500 mcg BID) during a 2-week run-in. No significant changes in percent predicted FEV1 were noted for other sub-groups analyzed (based on gender, race, or asthma severity). Flunisolide HFA did not increase the incidence of any treatment-emergent adverse events (TEAEs) by age, gender, race, or baseline asthma severity, either within the flunisolide HFA treatment groups or by comparison to placebo. CONCLUSIONS: Treatment with Aerospan was efficacious and safe across the entire age range of patients and across subpopulations determined by gender, race, and disease severity.
CLINICAL IMPLICATIONS: The unique properties of flunisolide HFA, with its small particle size and built-in spacer, offer an advanced treatment option for asthmatics. The flunisolide HFA product attributes may be particularly beneficial for pediatric patients. DISCLOSURE: John Karafilidis: Employee: Meda Pharmaceutical Employee William Berger: Consultant fee, speaker bureau, advisory committee, etc.: Meda Pharmaceutical Consultant Larry Gever: Employee: Meda Pharmaceutical Employee Nancy Ruiz: Employee: Meda Pharmaceutical Employee No Product/Research Disclosure Information