Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS

NCT ID: NCT01255709

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-01-31

Brief Summary

This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (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.

Detailed Description

The current study is designed to complement and expand the previous PK studies, API-E004-CL-B and API-E004-CL-B2, with emphasis on lower E004 dose strengths (at 90 and 100 mcg per inhalation), for a more thorough evaluation of the E004 PK profiles. Safety of E004 will also be evaluated, under augmented dose conditions.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm T1 Primatene Mist HFA

epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes

Group Type: EXPERIMENTAL

Arm T1: Primatene Mist HFA

Intervention Type: DRUG

epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes

Arm C Primatene Mist

epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes

Group Type: ACTIVE_COMPARATOR

Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)

Intervention Type: DRUG

epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes

Arm T2 Primatene Mist HFA

epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes

Group Type: EXPERIMENTAL

Arm T2: Primatene Mist HFA

Intervention Type: DRUG

epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes

Interventions

Arm T1: Primatene Mist HFA

epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes

Intervention Type: DRUG

Arm T2: Primatene Mist HFA

epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes

Intervention Type: DRUG

Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)

epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes

Intervention Type: DRUG

Other Intervention Names

epinephrine inhalation aerosol; epinephrine inhalation aerosol; epinephrine inhalation aerosol

Eligibility Criteria

Inclusion Criteria

• Generally healthy at screening;
• Body weight ≥ 50 kg for men and ≥ 45 kg for women;
• Sitting blood pressure ≤ 135/90 mmHg;
• Demonstrating negative hIV, HBsAG and DCV-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 prior to Screening;
• 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 drug/device studies, or donated blood, in the last 30 days prior to Screening;
• Other criteria apply

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amphastar Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Amphastar Pharmaceuticals, Inc.

Locations

Amphastar Study Site 1

Cypress, California, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 2019665 (View on PubMed)

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. doi: 10.1016/S1081-1206(10)61014-9.

Reference Type: BACKGROUND

PMID: 16400891 (View on PubMed)

Warren JB, Doble N, Dalton N, Ewan PW. Systemic absorption of inhaled epinephrine. Clin Pharmacol Ther. 1986 Dec;40(6):673-8. doi: 10.1038/clpt.1986.243.

Reference Type: BACKGROUND

PMID: 3780129 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 10936150 (View on PubMed)

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. doi: 10.1542/peds.106.5.1040.

Reference Type: BACKGROUND

PMID: 11061773 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 10535697 (View on PubMed)

Bondesson E, Friberg K, Soliman S, Lofdahl 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. doi: 10.1016/s0954-6111(98)90116-0.

Reference Type: BACKGROUND

PMID: 9616533 (View on PubMed)

Other Identifiers

API-E004-CL-B3

Identifier Type: -

Identifier Source: org_study_id