Phase 2 Completed N=23 Randomized Triple-blind Treatment

Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics

Asthma · Bronchospasm · wheezing · Shortness of Breath

Source: ClinicalTrials.gov NCT01188577 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcomePrimary: Baseline Concentration (C0) of Total Epinephrine — 2.6; 4.3 pg/mL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline Concentration (C0) of Total Epinephrine	2.6; 4.3	—
PRIMARY Peak Concentration (Cmax) of Total Epinephrine From Time Zero to 6 Hours Post-dose	862; 190	—
PRIMARY Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6]) for Total Epinephrine	8498; 6191	—
PRIMARY Time to Reach Peak Concentration (Tmax) for Total Epinephrine	2.3; 3.4	—
PRIMARY Half-life (t1/2) of Total Epinephrine	145.9; 289.8	—
PRIMARY Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose	2.6; 4.3; 861.5; 189.0; 379.4; 99.1	—

Eligibility Criteria

Inclusion Criteria

Generally healthy at screening;
No clinically significant respiratory, cardiovascular and other systemic or organic illnesses;
Body weight ≥ 50 kg for men and ≥ 45 kg for women,
Sitting blood pressure ≤ 135/90 mm Hg;
Demonstrating negative HIV, HBsAg and HCV-Ab screen tests;
Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
Properly consented
Other criteria apply

Exclusion Criteria

A smoking history of ≥10 pack-years, or having smoked within 6 months;
Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to Screening;
Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs;
Known intolerance or hypersensitivity to the study MDI ingredients;
Having been on other investigational studies, or donated blood, in the last 30 days;
Other Criteria Apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01188577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.