Conditions: Asthma Bronchospasm Wheezing Shortness of Breath
Keywords: asthma bronchospasm wheezing shortness of breath
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 23
Healthy volunteers: yes

Brief summary:
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. The current study is designed for a more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated, under augmented dose conditions.

Detailed description:
E004 is formulated with epinephrine free base as the active ingredient, and hydrofluoroalkane (HFA-134a) as the propellant.

In order to differentiate the inhaled epinephrine from the fluctuating background of endogenous epinephrine 1, a stable-isotope deuterium (2H) labeled epinephrine (epinephrine-d3) preparation will be used to formulate E004 inhalers, denoted as E004-d3. PK of E004 at 125 mcg of epinephrine-d3 per inhalation, will be compared to that of the currently marketed, non-labeled, Epinephrine-CFC MDI as the Reference Control (220 mcg per inhalation).

This study is a randomized, evaluator-blind, single dose, two-arm, crossover, PK study, to be conducted in \~18 healthy, male and female, adult volunteers. PK will be studied using E004-d3 at 125 mcg per inhalation (Arm T). A currently marketed, non-labeled, Epinephrine CFC-MDI will be used as a Reference Control (Arm C).

Arms:
arm 1: Experimental treatment of 10 inhalations of 125 mcg epinephrine base propelled by HFA 134a arm 2: Epinephrine Inhalation Aerosol, CFC propelled, 220 mcg/inhalation , 10 inhalations

Interventions: intervention 1: Epinephrine Inhalation Aerosol, HFA intervention 2: Epinephrine Inhalation Aerosol
Intervention descriptions: intervention 1: 10 inhalations of epinephrine inhalation aerosol, 125 mcg/inhalation intervention 2: Epinephrine Inhalation Aerosol, 220 mcg/ inhalation, 10 inhalations

Protocol document: