Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients
1 other identifier
interventional
373
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Jul 2011
Shorter than P25 for phase_3 asthma
33 active sites
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
First Submitted
Initial submission to the registry
May 19, 2011
CompletedFirst Posted
Study publicly available on registry
May 23, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 11, 2016
February 1, 2016
4 months
May 19, 2011
February 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose
Secondary Outcomes (3)
Monitor vital signs
2, 10, 20, 60, and 360 min after dosing
Cardiac rhythm
at baseline, 2, 10, 20, and 60 min post-dose
Blood glucose and potassium
baseline, and at 15 and 120 min post-dose
Study Arms (3)
Arm T
EXPERIMENTALArm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals
Arm P
PLACEBO COMPARATORPlacebo comparator as 2×Placebo QID, with 4-6 hr intervals
Arm A
ACTIVE COMPARATORActive comparator, Primatene Mist, 2×220 mcg/inhalation, QID, with 4-6 hr intervals
Interventions
Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
West Coast Clinical Trials
Costa Mesa, California, 92626, United States
Southern California Institute for Respiratory Diseases
Los Angeles, California, 90048, United States
Asthma and Allergy Associates of Southern California
Mission Viejo, California, 92691, United States
CHOC PSF, Division of Allergy, Asthma and Immunology
Orange, California, 92868, United States
Allergy & Asthma Assocaites of Santa Clara Valley
San Jose, California, 95117, United States
Colorado Allergy & Asthma Centers
Centennial, Colorado, 80112, United States
Colorado Allergy & Asthma Centers
Denver, Colorado, 80230, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, 80033, United States
Atlanta Allergy & Asthma Clinic
Woodstock, Georgia, 30188, United States
Iowa Clinical Research Corporation
Iowa City, Iowa, 52240, United States
Family Allergy & Asthma Research Institute
Louisville, Kentucky, 40215, United States
Northeast Medical Research Associates
No. Dartmouth, Massachusetts, 02747, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
Clinical Research Institute
Plymouth, Minnesota, 55441, United States
The Clinical Research Center
St Louis, Missouri, 63141, United States
Clinical Research Group of Montana
Bozeman, Montana, 59718, United States
The Asthma & Allergy Center
Bellevue, Nebraska, 68123, United States
Princeton Center for Clinical Research
Skillman, New Jersey, 08558, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Intergated Medical Research
Ashland, Oregon, 97520, United States
Allergy and Asthma Research Group
Eugene, Oregon, 97401, United States
Baker Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, 97035, United States
The Clinical Research Institute of Southern Oregon
Medford, Oregon, 97504, United States
Transitional Clinical Research
Portland, Oregon, 97213, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241, United States
Asthma & Allergy Research Associates
Upland, Pennsylvania, 17013, United States
National Allergy, Asthma & Urticaria Centers of Charleston
Charleston, South Carolina, 29406, United States
Western Sky Research
El Paso, Texas, 79903, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Sylvana Research Associates
San Antonio, Texas, 78229, United States
Allergy Partners
Richmond, Virginia, 23229, United States
ASTHMA, Inc.
Seattle, Washington, 98105, United States
Related Publications (7)
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: 2019665BACKGROUNDHendeles 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: 16400891BACKGROUNDWarren 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: 3780129BACKGROUNDCripps 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: 10919679BACKGROUNDDickinson 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: 10936150BACKGROUNDSimons 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: 11061773BACKGROUNDKerwin 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.
PMID: 31959019DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2011
First Posted
May 23, 2011
Study Start
July 1, 2011
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
March 11, 2016
Record last verified: 2016-02