Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients
NCT ID: NCT01357642
Last Updated: 2016-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
373 participants
INTERVENTIONAL
2011-07-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm T
Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals
Epinephrine inhalation aerosol
Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals
Arm P
Placebo comparator as 2×Placebo QID, with 4-6 hr intervals
Placebo
Placebo for epinephrine inhalation aerosol, formulation without epinephrine
Arm A
Active comparator, Primatene Mist, 2×220 mcg/inhalation, QID, with 4-6 hr intervals
epinephrine inhalation aerosol
epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals
Interventions
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Epinephrine inhalation aerosol
Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals
Placebo
Placebo for epinephrine inhalation aerosol, formulation without epinephrine
epinephrine inhalation aerosol
epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
75 Years
ALL
No
Sponsors
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Amphastar Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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West Coast Clinical Trials
Costa Mesa, California, United States
Southern California Institute for Respiratory Diseases
Los Angeles, California, United States
Asthma and Allergy Associates of Southern California
Mission Viejo, California, United States
CHOC PSF, Division of Allergy, Asthma and Immunology
Orange, California, United States
Allergy & Asthma Assocaites of Santa Clara Valley
San Jose, California, United States
Colorado Allergy & Asthma Centers
Centennial, Colorado, United States
Colorado Allergy & Asthma Centers
Denver, Colorado, United States
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States
Atlanta Allergy & Asthma Clinic
Woodstock, Georgia, United States
Iowa Clinical Research Corporation
Iowa City, Iowa, United States
Family Allergy & Asthma Research Institute
Louisville, Kentucky, United States
Northeast Medical Research Associates
No. Dartmouth, Massachusetts, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Clinical Research Institute
Plymouth, Minnesota, United States
The Clinical Research Center
St Louis, Missouri, United States
Clinical Research Group of Montana
Bozeman, Montana, United States
The Asthma & Allergy Center
Bellevue, Nebraska, United States
Princeton Center for Clinical Research
Skillman, New Jersey, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Intergated Medical Research
Ashland, Oregon, United States
Allergy and Asthma Research Group
Eugene, Oregon, United States
Baker Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, United States
The Clinical Research Institute of Southern Oregon
Medford, Oregon, United States
Transitional Clinical Research
Portland, Oregon, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States
Asthma & Allergy Research Associates
Upland, Pennsylvania, United States
National Allergy, Asthma & Urticaria Centers of Charleston
Charleston, South Carolina, United States
Western Sky Research
El Paso, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Allergy Partners
Richmond, Virginia, United States
ASTHMA, Inc.
Seattle, Washington, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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API-E004-CL-C
Identifier Type: -
Identifier Source: org_study_id
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