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

Information source: Amphastar Pharmaceuitcals, Inc.
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma; Bronchospasm; Wheezing; Shortness of Breath

Intervention: Epinephrine Inhalation Aerosol, HFA (Drug); Epinephrine Inhalation Aerosol (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Amphastar Pharmaceuitcals, Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Amphastar Pharmaceuticals, Inc.

Overall contact:
Medical Director, Phone: (909) 980-9484

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.

Clinical Details

Official title: Epinephrine Inhalation Aerosol USP, an HFA-MDI CLINICAL STUDY-B2 FOR ASSESSMENT OF PHARMACOKINETICS (A Randomized, Evaluator-Blind, Single-Dose, Two Arm, Crossover, PK Study in Healthy Volunteers)

Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pharmacokinetic Parameters

Secondary outcome:

Vital Signs

Telemetry ECG

12-lead ECG

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).

Eligibility

Minimum age: 18 Years. Maximum age: 30 Years. Gender(s): Both.

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

Locations and Contacts

Medical Director, Phone: (909) 980-9484

Armstrong Study Site One, Cypress, California 90630, United States; Recruiting
Medical Director, Phone: 909-980-9484
Additional Information

Related publications:

Pinnas JL, Schachtel BP, Chen TM, Roseberry HR, Thoden WR. Inhaled epinephrine and oral theophylline-ephedrine in the treatment of asthma. J Clin Pharmacol. 1991 Mar;31(3):243-7.

Hendeles L, Marshik PL, Ahrens R, Kifle Y, Shuster J. Response to nonprescription epinephrine inhaler during nocturnal asthma. Ann Allergy Asthma Immunol. 2005 Dec;95(6):530-4.

Warren JB, Doble N, Dalton N, Ewan PW. Systemic absorption of inhaled epinephrine. Clin Pharmacol Ther. 1986 Dec;40(6):673-8.

Cripps A, Riebe M, Schulze M, Woodhouse R. Pharmaceutical transition to non-CFC pressurized metered dose inhalers. Respir Med. 2000 Jun;94 Suppl B:S3-9.

Dickinson BD, Altman RD, Deitchman SD, Champion HC. Safety of over-the-counter inhalers for asthma: report of the council on scientific affairs. Chest. 2000 Aug;118(2):522-6.

Simons FE, Gu X, Johnston LM, Simons KJ. Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? Pediatrics. 2000 Nov;106(5):1040-4.

Kushner DJ, Baker A, Dunstall TG. Pharmacological uses and perspectives of heavy water and deuterated compounds. Can J Physiol Pharmacol. 1999 Feb;77(2):79-88. Review.

Bondesson E, Friberg K, Soliman S, Löfdahl CG. Safety and efficacy of a high cumulative dose of salbutamol inhaled via Turbuhaler or via a pressurized metered-dose inhaler in patients with asthma. Respir Med. 1998 Feb;92(2):325-30.

Starting date: August 2010
Last updated: August 24, 2010

Page last updated: October 04, 2010

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