NCT01255709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2010

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 17, 2016

Status Verified

February 1, 2016

Enrollment Period

1 month

First QC Date

December 3, 2010

Last Update Submit

February 18, 2016

Conditions

Asthma

Keywords

Asthmashortness of breathwheezing

Outcome Measures

Primary Outcomes (1)

  • 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

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

Secondary Outcomes (3)

  • Vital Signs

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

  • 12-lead Electrocardiogram (ECG)

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

  • Telemetry ECG

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

Study Arms (3)

Arm T1 Primatene Mist HFA

EXPERIMENTAL

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

Drug: Arm T1: Primatene Mist HFA

Arm C Primatene Mist

ACTIVE COMPARATOR

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

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

Arm T2 Primatene Mist HFA

EXPERIMENTAL

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

Drug: Arm T2: Primatene Mist HFA

Interventions

Arm T1: Primatene Mist HFADRUG

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

Also known as: epinephrine inhalation aerosol
Arm T1 Primatene Mist HFA
Arm T2: Primatene Mist HFADRUG

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

Also known as: epinephrine inhalation aerosol
Arm T2 Primatene Mist HFA
Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)DRUG

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

Also known as: epinephrine inhalation aerosol
Arm C Primatene Mist

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amphastar Study Site 1

Cypress, California, 90630, United States

Location

Related Publications (8)

  • 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.

    PMID: 2019665BACKGROUND

  • 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.

    PMID: 16400891BACKGROUND

  • 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.

    PMID: 3780129BACKGROUND

  • 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.

    PMID: 10919679BACKGROUND

  • 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.

    PMID: 10936150BACKGROUND

  • 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.

    PMID: 11061773BACKGROUND

  • 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.

    PMID: 10535697BACKGROUND

  • 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.

    PMID: 9616533BACKGROUND

MeSH Terms

Conditions

AsthmaDyspneaRespiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Director

    Amphastar Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 7, 2010

Study Start

December 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 17, 2016

Record last verified: 2016-02

Locations

US(1)