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CompletedNCT01255709Updated Mar 17, 2016

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

A Phase 2 interventional study of Arm T1: Primatene Mist HFA and Arm T2: Primatene Mist HFA in Asthma, sponsored by Amphastar Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-17.

Sponsored by Amphastar Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthma

Keywords

  • Asthma
  • shortness of breath
  • wheezing
03

In context

Asthma

4,010 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 24 is below the median of 83 across 2,814 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Amphastar Pharmaceuticals, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Arm T1 Primatene Mist HFA

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

    Drug: Arm T1: Primatene Mist HFA

  • Active comparator
    Arm C Primatene Mist

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

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

  • Experimental
    Arm T2 Primatene Mist HFA

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

    Drug: Arm T2: Primatene Mist HFA

Interventions

  • DrugArm T1: Primatene Mist HFA

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

    Also known as: epinephrine inhalation aerosol

  • DrugArm T2: Primatene Mist HFA

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

    Also known as: epinephrine inhalation aerosol

  • DrugArm C: Primatene Mist (epinephrine inhalation aerosol, USP)

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

    Also known as: epinephrine inhalation aerosol

06

What researchers measure

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

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

Secondary outcomes

  1. Vital Signs

    Systolic and Diastolic Blood pressure and heart rate

    Time frame: within 30 min predose, at 30, 60 and 360 min postdose

  2. 12-lead Electrocardiogram (ECG)

    12 lead ECG (Routine and QT/QTc intervals)

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

  3. Telemetry ECG

    Telemetry recording of heart rate

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

07

Study locations

1 site
  • Amphastar Study Site 1
    Cypress, California 90630, United States
08

References and documents

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. doi: 10.1002/j.1552-4604.1991.tb04969.x. PubMed 2019665 ↗
  • 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. PubMed 16400891 ↗
  • 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. PubMed 3780129 ↗
  • 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. PubMed 10919679 ↗
  • 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. PubMed 10936150 ↗
  • 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. PubMed 11061773 ↗
  • 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. PubMed 10535697 ↗
  • 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. PubMed 9616533 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01255709
Lead sponsor
Amphastar Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Dec 7, 2010
Start date
Dec 2010
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Mar 17, 2016

Study contacts

Medical Director
study director · Amphastar Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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