Open AccessA Dose-Ranging Study of Epinephrine Hydrofluroalkane Metered-Dose Inhaler (Primatene® MIST) in Subjects with Intermittent or Mild-to-Moderate Persistent Asthma
Author(s) -
Edward Kerwin,
Donald P. Tashkin,
Thomas Murphy,
George Bensch,
Tony Marrs,
Mary Z Luo,
Jack Zhang
Publication year - 2020
Publication title -
journal of aerosol medicine and pulmonary drug delivery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.678
H-Index - 68
eISSN - 1941-2703
pISSN - 1941-2711
DOI - 10.1089/jamp.2019.1558
Subject(s) - medicine , epinephrine , chlorofluorocarbon , inhaler , asthma , metered dose inhaler , anesthesia , dosing , bronchodilator , placebo , crossover study , inhalation , spirometry , physics , alternative medicine , pathology , meteorology
Background: Two sequential single-dose crossover dose-ranging studies were performed to evaluate the clinical efficacy and safety profile of epinephrine hydrofluroalkane (HFA) metered-dose inhaler (MDI) formulation at various doses in subjects with asthma. Methods: In these multicenter, multiarm, double-blinded, or evaluator-blinded studies, subjects were randomized to receive the epinephrine HFA (Primatene ® MIST HFA) MDI medication at doses ranging from 90 to 440 μg/dose, as well as to a placebo (PLA) control and an active control of epinephrine CFC (chlorofluorocarbon) MDI (Primatene ® MIST CFC) at 220 μg/inhalation. Results: Spirometry testing for FEV1 (Forced Expiratory Volume in one second) demonstrated statistically significant improvements over PLA for epinephrine HFA MDI at all doses above 125 μg, as the amount out of the actuator (i.e., mouthpiece). The efficacy results for epinephrine HFA MDI in the dose range of 125-250 μg were also comparable to epinephrine CFC MDI (220 μg/inh). Safety assessments demonstrated minimal safety concerns for all treatment groups. No notable safety differences were observed between the studied doses of epinephrine HFA MDI and the active control formulation of epinephrine CFC MDI. Conclusion: The findings indicate that epinephrine HFA MDI provided clinically significant bronchodilator efficacy with minimal safety concerns in a dose range of 125-250 μg. These findings confirmed the optimal treatment doses of 125-250 μg that were appropriate for use in longer term 12 and 26 week chronic dosing studies of epinephrine HFA MDI for patients with intermittent or mild to moderate persistent asthma. Clinical trials registration number: NCT01025648.