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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm T | Experimental | Arm T is the experimental treatment arm consisting of 2 x 125 mcg/inhalations of E004, QID, with 4-6 hr intervals |
|
| Arm P | Placebo Comparator | Placebo comparator as 2×Placebo QID, with 4-6 hr intervals |
|
| Arm A | Active Comparator | Active comparator, Primatene Mist, 2×220 mcg/inhalation, QID, with 4-6 hr intervals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrine inhalation aerosol | Drug | Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Monitor vital signs | Assess blood pressure, pulse rate | 2, 10, 20, 60, and 360 min after dosing |
| Cardiac rhythm | At study visits 1 and 5 only, perform 12 lead ECG |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials | Costa Mesa | California | 92626 | United States | ||
| Southern California Institute for Respiratory Diseases |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2019665 | Background | 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. | |
| 16400891 | Background | 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. |
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| Placebo | Drug | Placebo for epinephrine inhalation aerosol, formulation without epinephrine |
|
| epinephrine inhalation aerosol | Drug | epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals |
|
|
| at baseline, 2, 10, 20, and 60 min post-dose |
| Blood glucose and potassium | Monitor blood glucose and potassium levels to assure appropriate balance | baseline, and at 15 and 120 min post-dose |
| 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 |
| 3780129 | Background | 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. |
| 10919679 | Background | 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. |
| 10936150 | Background | 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. |
| 11061773 | Background | 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. |
| 31959019 | Derived | 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. |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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