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Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Epinephrine inhalation aerosol
Placebo
epinephrine inhalation aerosol
Sponsored by
Amphastar Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment.
  • No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening
  • Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout period.
  • Demonstrating a Screening Baseline FEV1 that is 50 - 90% of predicted normal value.
  • Demonstrating at least a 12% Airway Reversibility.
  • Demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter.
  • Female patients of child-bearing potential must be non-pregnant and non-lactating at Screening and throughout the study, and must use an acceptable method of contraception during the study.

Exclusion Criteria:

  • A smoking history of 10-pack years, or having smoked within 12 months of screening.
  • Any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma.
  • Concurrent clinically significant diseases.
  • Known intolerance or hypersensitivity to any component of the study drugs.
  • Recent infection of the respiratory tract, before screening.
  • Use of prohibited medications.
  • Having been on other investigational drug/device studies in the last 30 days prior to screening.
  • Known or highly suspected substance abuse.

Sites / Locations

  • West Coast Clinical Trials
  • Southern California Institute for Respiratory Diseases
  • Asthma and Allergy Associates of Southern California
  • CHOC PSF, Division of Allergy, Asthma and Immunology
  • Allergy & Asthma Assocaites of Santa Clara Valley
  • Colorado Allergy & Asthma Centers
  • Colorado Allergy & Asthma Centers
  • Rocky Mountain Center for Clinical Research
  • Atlanta Allergy & Asthma Clinic
  • Iowa Clinical Research Corporation
  • Family Allergy & Asthma Research Institute
  • Northeast Medical Research Associates
  • Clinical Research Institute
  • Clinical Research Institute
  • The Clinical Research Center
  • Clinical Research Group of Montana
  • The Asthma & Allergy Center
  • Princeton Center for Clinical Research
  • North Carolina Clinical Research
  • New Horizons Clinical Research
  • Intergated Medical Research
  • Allergy and Asthma Research Group
  • Baker Allergy, Asthma & Dermatology Research Center
  • The Clinical Research Institute of Southern Oregon
  • Transitional Clinical Research
  • Allergy and Clinical Immunology Associates
  • Asthma & Allergy Research Associates
  • National Allergy, Asthma & Urticaria Centers of Charleston
  • Western Sky Research
  • Central Texas Health Research
  • Sylvana Research Associates
  • Allergy Partners
  • ASTHMA, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Arm T

Arm P

Arm A

Arm Description

Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals

Placebo comparator as 2×Placebo QID, with 4-6 hr intervals

Active comparator, Primatene Mist, 2×220 mcg/inhalation, QID, with 4-6 hr intervals

Outcomes

Primary Outcome Measures

Change in Area Under the Curve (AUC) versus placebo
Serial FEV1 measurements to demonstrate the mean AUC of change in percent FEV1 from same-day baseline of E004 (Treatment T; Epinephrine-HFA) versus Placebo-HFA (Treatment P) is the primary efficacy endpoint.

Secondary Outcome Measures

Monitor vital signs
Assess blood pressure, pulse rate
Cardiac rhythm
At study visits 1 and 5 only, perform 12 lead ECG
Blood glucose and potassium
Monitor blood glucose and potassium levels to assure appropriate balance

Full Information

First Posted
May 19, 2011
Last Updated
February 11, 2016
Sponsor
Amphastar Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01357642
Brief Title
Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients
Official Title
Epinephrine Inhalation Aerosol USP, an HFA-MDI: Clinical Study-C For Evaluation Of Efficacy And Safety In Asthma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amphastar Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, bronchial asthma, shortness of breath

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
373 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm T
Arm Type
Experimental
Arm Description
Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals
Arm Title
Arm P
Arm Type
Placebo Comparator
Arm Description
Placebo comparator as 2×Placebo QID, with 4-6 hr intervals
Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Active comparator, Primatene Mist, 2×220 mcg/inhalation, QID, with 4-6 hr intervals
Intervention Type
Drug
Intervention Name(s)
Epinephrine inhalation aerosol
Other Intervention Name(s)
epinephrine inhalation aerosol - HFA propelled
Intervention Description
Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for epinephrine inhalation aerosol, formulation without epinephrine
Intervention Type
Drug
Intervention Name(s)
epinephrine inhalation aerosol
Other Intervention Name(s)
Primatene Mist
Intervention Description
epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals
Primary Outcome Measure Information:
Title
Change in Area Under the Curve (AUC) versus placebo
Description
Serial FEV1 measurements to demonstrate the mean AUC of change in percent FEV1 from same-day baseline of E004 (Treatment T; Epinephrine-HFA) versus Placebo-HFA (Treatment P) is the primary efficacy endpoint.
Time Frame
at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose
Secondary Outcome Measure Information:
Title
Monitor vital signs
Description
Assess blood pressure, pulse rate
Time Frame
2, 10, 20, 60, and 360 min after dosing
Title
Cardiac rhythm
Description
At study visits 1 and 5 only, perform 12 lead ECG
Time Frame
at baseline, 2, 10, 20, and 60 min post-dose
Title
Blood glucose and potassium
Description
Monitor blood glucose and potassium levels to assure appropriate balance
Time Frame
baseline, and at 15 and 120 min post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with documented asthma, requiring inhaled epinephrine or beta 2-agonist treatment. No significant changes in asthma therapy and no asthma-related hospitalization or emergency visits, within 4 weeks prior to Screening Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout period. Demonstrating a Screening Baseline FEV1 that is 50 - 90% of predicted normal value. Demonstrating at least a 12% Airway Reversibility. Demonstrating satisfactory techniques in the use of metered-dose inhaler and a hand held peak expiratory flow meter. Female patients of child-bearing potential must be non-pregnant and non-lactating at Screening and throughout the study, and must use an acceptable method of contraception during the study. Exclusion Criteria: A smoking history of 10-pack years, or having smoked within 12 months of screening. Any current or past medical conditions that, per investigator discretion, might significantly affect responses to the study drugs, other than asthma. Concurrent clinically significant diseases. Known intolerance or hypersensitivity to any component of the study drugs. Recent infection of the respiratory tract, before screening. Use of prohibited medications. Having been on other investigational drug/device studies in the last 30 days prior to screening. Known or highly suspected substance abuse.
Facility Information:
Facility Name
West Coast Clinical Trials
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Southern California Institute for Respiratory Diseases
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Asthma and Allergy Associates of Southern California
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
CHOC PSF, Division of Allergy, Asthma and Immunology
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Allergy & Asthma Assocaites of Santa Clara Valley
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Colorado Allergy & Asthma Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Colorado Allergy & Asthma Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Rocky Mountain Center for Clinical Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Atlanta Allergy & Asthma Clinic
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30188
Country
United States
Facility Name
Iowa Clinical Research Corporation
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Facility Name
Family Allergy & Asthma Research Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Northeast Medical Research Associates
City
No. Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
The Clinical Research Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical Research Group of Montana
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
The Asthma & Allergy Center
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Princeton Center for Clinical Research
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Intergated Medical Research
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Allergy and Asthma Research Group
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Baker Allergy, Asthma & Dermatology Research Center
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
The Clinical Research Institute of Southern Oregon
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Transitional Clinical Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Allergy and Clinical Immunology Associates
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Asthma & Allergy Research Associates
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
17013
Country
United States
Facility Name
National Allergy, Asthma & Urticaria Centers of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Western Sky Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Allergy Partners
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
ASTHMA, Inc.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
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
background
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
background
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
background
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
background
PubMed Identifier
31959019
Citation
Kerwin EM, Tashkin DP, Korenblat PE, Greos LS, Pearlman DS, Bensch GW, Miller SD, Marrs T, Luo MZ, Zhang JY. Long-term safety and efficacy studies of epinephrine HFA metered-dose inhaler (Primatene(R) Mist): a two-stage randomized controlled trial. J Asthma. 2021 May;58(5):633-644. doi: 10.1080/02770903.2020.1713147. Epub 2020 Jan 20.
Results Reference
derived

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Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients

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