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A Dose-Ranging Study of Epinephrine Hydrofluroalkane Metered-Dose Inhaler (Primatene(®) MIST) in Subjects with Intermittent or Mild-to-Moderate Persistent Asthma

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, do...

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Autores principales: Kerwin, Edward M., Tashkin, Donald P., Murphy, Thomas R., Bensch, George W., Marrs, Tony, Luo, Mary Z., Zhang, Jack Y.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mary Ann Liebert, Inc., publishers 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7407001/
https://www.ncbi.nlm.nih.gov/pubmed/32150492
http://dx.doi.org/10.1089/jamp.2019.1558
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author Kerwin, Edward M.
Tashkin, Donald P.
Murphy, Thomas R.
Bensch, George W.
Marrs, Tony
Luo, Mary Z.
Zhang, Jack Y.
author_facet Kerwin, Edward M.
Tashkin, Donald P.
Murphy, Thomas R.
Bensch, George W.
Marrs, Tony
Luo, Mary Z.
Zhang, Jack Y.
author_sort Kerwin, Edward M.
collection PubMed
description 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.
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spelling pubmed-74070012020-08-06 A Dose-Ranging Study of Epinephrine Hydrofluroalkane Metered-Dose Inhaler (Primatene(®) MIST) in Subjects with Intermittent or Mild-to-Moderate Persistent Asthma Kerwin, Edward M. Tashkin, Donald P. Murphy, Thomas R. Bensch, George W. Marrs, Tony Luo, Mary Z. Zhang, Jack Y. J Aerosol Med Pulm Drug Deliv Original Research 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. Mary Ann Liebert, Inc., publishers 2020-08-01 2020-07-28 /pmc/articles/PMC7407001/ /pubmed/32150492 http://dx.doi.org/10.1089/jamp.2019.1558 Text en © Edward M. Kerwin, et al., 2020. Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
spellingShingle Original Research
Kerwin, Edward M.
Tashkin, Donald P.
Murphy, Thomas R.
Bensch, George W.
Marrs, Tony
Luo, Mary Z.
Zhang, Jack Y.
A Dose-Ranging Study of Epinephrine Hydrofluroalkane Metered-Dose Inhaler (Primatene(®) MIST) in Subjects with Intermittent or Mild-to-Moderate Persistent Asthma
title A Dose-Ranging Study of Epinephrine Hydrofluroalkane Metered-Dose Inhaler (Primatene(®) MIST) in Subjects with Intermittent or Mild-to-Moderate Persistent Asthma
title_full A Dose-Ranging Study of Epinephrine Hydrofluroalkane Metered-Dose Inhaler (Primatene(®) MIST) in Subjects with Intermittent or Mild-to-Moderate Persistent Asthma
title_fullStr A Dose-Ranging Study of Epinephrine Hydrofluroalkane Metered-Dose Inhaler (Primatene(®) MIST) in Subjects with Intermittent or Mild-to-Moderate Persistent Asthma
title_full_unstemmed A Dose-Ranging Study of Epinephrine Hydrofluroalkane Metered-Dose Inhaler (Primatene(®) MIST) in Subjects with Intermittent or Mild-to-Moderate Persistent Asthma
title_short A Dose-Ranging Study of Epinephrine Hydrofluroalkane Metered-Dose Inhaler (Primatene(®) MIST) in Subjects with Intermittent or Mild-to-Moderate Persistent Asthma
title_sort dose-ranging study of epinephrine hydrofluroalkane metered-dose inhaler (primatene(®) mist) in subjects with intermittent or mild-to-moderate persistent asthma
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7407001/
https://www.ncbi.nlm.nih.gov/pubmed/32150492
http://dx.doi.org/10.1089/jamp.2019.1558
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