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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Arm T1: Primatene Mist HFA

Arm T2: Primatene Mist HFA

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

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, shortness of breath, wheezing

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Amphastar Study Site 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Arm T1 Primatene Mist HFA

Arm C Primatene Mist

Arm T2 Primatene Mist HFA

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetics including maximum concentration and area under the curve

Samples will be analyzed with an established LC/MS/MS method, with a quantitative detection limit of 0.02 ng/mL, for both epinephrine-d3 and epinephrine-h3. Mean Maximum concentration of epinephrine (Cmax for epinephrine) Mean Area Under the Curve (AUC) for epinephrine Time to maximum concentration (tmax) and Half life of the drug (t1/2) Epinephrine concentrations versus time

Secondary Outcome Measures

Vital Signs

Systolic and Diastolic Blood pressure and heart rate

12-lead Electrocardiogram (ECG)

12 lead ECG (Routine and QT/QTc intervals)

Telemetry ECG

Telemetry recording of heart rate

Full Information

NCT ID

NCT01255709

First Posted

December 3, 2010

Last Updated

February 18, 2016

Sponsor

Amphastar Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01255709

Brief Title

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

Official Title

CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amphastar Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, shortness of breath, wheezing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm T1 Primatene Mist HFA

Arm Type

Experimental

Arm Description

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

Arm Title

Arm C Primatene Mist

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm T2 Primatene Mist HFA

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Arm T1: Primatene Mist HFA

Other Intervention Name(s)

epinephrine inhalation aerosol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Arm T2: Primatene Mist HFA

Other Intervention Name(s)

epinephrine inhalation aerosol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

epinephrine inhalation aerosol

Intervention Description

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

Primary Outcome Measure Information:

Title

Pharmacokinetics including maximum concentration and area under the curve

Description

Time Frame

-30, 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 min postdose.

Secondary Outcome Measure Information:

Title

Vital Signs

Description

Systolic and Diastolic Blood pressure and heart rate

Time Frame

within 30 min predose, at 30, 60 and 360 min postdose

Title

12-lead Electrocardiogram (ECG)

Description

12 lead ECG (Routine and QT/QTc intervals)

Time Frame

within 30 min pre-dose, and at 15 and 120 min post-dose

Title

Telemetry ECG

Description

Telemetry recording of heart rate

Time Frame

within 30 min pre-dose, and during the initial 5 min post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Amphastar Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Amphastar Study Site 1

City

Cypress

State/Province

California

ZIP/Postal Code

90630

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

2019665

Citation

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. doi: 10.1002/j.1552-4604.1991.tb04969.x.

Results Reference

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PubMed Identifier

16400891

Citation

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.

Results Reference

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PubMed Identifier

3780129

Citation

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.

Results Reference

background

PubMed Identifier

10919679

Citation

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.

Results Reference

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PubMed Identifier

10936150

Citation

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. doi: 10.1378/chest.118.2.522.

Results Reference

background

PubMed Identifier

11061773

Citation

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.

Results Reference

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PubMed Identifier

10535697

Citation

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.

Results Reference

background

PubMed Identifier

9616533

Citation

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.

Results Reference

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

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