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Safety Study in Adolescent and Adult Patients With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Primatene Mist
Epinephrine inhalation
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:

  • Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation
  • Male and female asthma patients aged 12 - 75 years
  • 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
  • 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

  • Amphastar Site 0006
  • Amphastar Site 0005
  • Amphastar Site 0004
  • Amphastar Site 0001
  • Amphastar Site 0003
  • Amphastar Site 0008
  • Amphastar Site 0009
  • Amphastar Site 0011
  • Amphastar Site 0013
  • Amphastar Site 0014
  • Amphastar Site 0015
  • Amphastar Site 0016
  • Amphastar Site 0017
  • Amphastar Site 0019
  • Amphastar Site 0020
  • Amphastar Site 0018
  • Amphastar Site 0021
  • Amphastar Site 0024
  • Amphastar Site 0022
  • Amphastar Site 0023
  • Amphastar Site 0025
  • Amphastar Site 0026
  • Amphastar Site 0029
  • Amphastar Site 0031
  • Amphastar Site 0030
  • Amphastar Site 0033
  • Amphastar Site 0034

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 epinephrine inhalation, QID, with 4-6 hr intervals

Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals

Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals

Outcomes

Primary Outcome Measures

Adverse Events
Recording of all adverse events experienced during the course of the study

Secondary Outcome Measures

Change in 12 lead ECG including QT/QTc analysis
A 12-lead ECG (routine and QT/QTc) will be measured and recorded, provided that dosing of study drug has been performed greater than 1 hour prior to conducting the measurements.
Asthma Exacerbations
Review use of resuce inhaler for treatment of asthma exacrbations occuring between doses of study medication.

Full Information

First Posted
November 15, 2011
Last Updated
February 10, 2017
Sponsor
Amphastar Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01476904
Brief Title
Safety Study in Adolescent and Adult Patients With Asthma
Official Title
A 3-month Safety Evaluation Extension to the 12-week E004-C Study in Asthma Patients (A Double Blinded, Placebo-controlled, Parallel, 3-month Safety Study in Adolescent and Adult Patients With Asthma)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
July 2012 (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
E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner.

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
208 (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 epinephrine inhalation, QID, with 4-6 hr intervals
Arm Title
Arm P
Arm Type
Placebo Comparator
Arm Description
Arm P is a placebo comparator consisting of 2× 0 mcg of placebo inhalations, QID, with 4-6 hr intervals
Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Arm A is an active comparator, Primatene Mist, consisting of 2× 220 mcg/inhalation, QID, with 4-6 hr intervals
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0 mcg/inhalation, 2 inhalations QID
Intervention Type
Drug
Intervention Name(s)
Primatene Mist
Intervention Description
220 mcg/inhalation, 2 inhalations QID
Intervention Type
Drug
Intervention Name(s)
Epinephrine inhalation
Intervention Description
125 mcg/inhalation, 2 inhalations QID
Primary Outcome Measure Information:
Title
Adverse Events
Description
Recording of all adverse events experienced during the course of the study
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Change in 12 lead ECG including QT/QTc analysis
Description
A 12-lead ECG (routine and QT/QTc) will be measured and recorded, provided that dosing of study drug has been performed greater than 1 hour prior to conducting the measurements.
Time Frame
Study visit 4, 8 and 12, greater than one hour after last dose
Title
Asthma Exacerbations
Description
Review use of resuce inhaler for treatment of asthma exacrbations occuring between doses of study medication.
Time Frame
up to 12 weeks

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: Only subjects who have successfully completed the E004-C study within the last 135 days or those who are actively enrolled in the current study E004-C at the time of the study extension initiation Male and female asthma patients aged 12 - 75 years 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Safety Monitor
Organizational Affiliation
Amphastar Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Amphastar Site 0006
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Amphastar Site 0005
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Amphastar Site 0004
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Amphastar Site 0001
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Amphastar Site 0003
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
Amphastar Site 0008
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Amphastar Site 0009
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Amphastar Site 0011
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Facility Name
Amphastar Site 0013
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Amphastar Site 0014
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Amphastar Site 0015
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Amphastar Site 0016
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Amphastar Site 0017
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Amphastar Site 0019
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Amphastar Site 0020
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Amphastar Site 0018
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Amphastar Site 0021
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Amphastar Site 0024
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Amphastar Site 0022
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Amphastar Site 0023
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Amphastar Site 0025
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Amphastar Site 0026
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Facility Name
Amphastar Site 0029
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Amphastar Site 0031
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Amphastar Site 0030
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Amphastar Site 0033
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Amphastar Site 0034
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
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
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
9872837
Citation
Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.
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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Safety Study in Adolescent and Adult Patients With Asthma

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