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This is a multi-center, randomized, double-blinded, placebo-controlled, parallel, 4-week study in 60 pediatric patients (4-11 years old) with asthma, comparing E004 with Placebo HFA-MDI in pediatric patients who are 4-11 years of age with asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P - Placebo-HFA | Placebo Comparator | Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID |
|
| T - E004 (Epinephrine Inhalation Aerosol) HFA-MDI | Experimental | E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E004 (Epinephrine Inhalation Aerosol) HFA-MDI | Drug | E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint AUC of FEV1's relative change | bronchodilator effect expressed as AUC of FEV1's relative change (from the same day baseline) versus time, defined as AUC of ΔFEV1%. | Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of FEV1 volume changes (AUC of change in FEV1) | determination of the change in FEV1 from baseline at visit to to post treatment at Visit 3 | Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose |
| Maximum of change in FEV1% (Fmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Gao, M.D. | Amphastar Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphastar Site 5 | Costa Mesa | California | 92626 | United States | ||
| Amphastar Site 8 |
| 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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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo-HFA | Drug | Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID |
|
Evaluation of maximum percent change in FEV1 |
| Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose |
| Curves of change in FEV1, and change in FEV1%, versus time | Evaluation of curves of change in FEV1 and percent change in FEV1 over time | Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose |
| Time to onset of bronchodilator effect (to onset), determined the time point (within 60 minutes) where FEV1 first reaches ≥12% above Same-Day Baseline. | Evaluation of how much time elapses (within 60 minutes), until FEV1 first reaches ≥12% above Same-Day Baseline. | Study Visits 1and 3 within 60 minutes post dose |
| The time to peak FEV1 effect (tmax), defined as the time of Fmax. | Evaluation of how much time elapses until FEV1 reaches its peak | Study Visits 1 and 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose |
| Duration of efficacy (duration), defined as the total length of time when ΔFEV1% reaches and stays ≥12% above Same-Day Baseline. | Evaluation of the total length of time it takes until the change in FEV1% reaches and stays ≥12% above Same-Day Baseline. | Study Weeks 1and 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose |
| Percentage of positive responders (R%), including all subjects whose Fmax reaches ≥12% above Same-Day Baseline. | Evaluation of what percentage of subjects are positive responders (R%), including all subjects whose Fmaxreaches ≥12% above Same-Day Baseline. | Study Weeks 1 and 3 within 60 minutes post dose |
| Mean daily morning pre-dose Peak Expiratory Flow Rate (PEF) | Evaluation of the mean of daily morning pre-dose Expiratory Flow Rate | daily pre-dose |
| Evaluation of Vital Signs | Monitoring of vital signs (SBP/DBP, and heart rate) at the Screening Visit (Baseline and 30 min post-dose), and at the baseline, 3, 20, 60 and 360 minute time points during the study | predose, and 3, 20, 60, 360 minutes post-dose |
| 12-lead ECG | Recording of 12-lead ECG (Routine and QT/QTc) at Screening Visit Baseline, and at the baseline, 3, 20 and 60 minute time points during Study Visits 1 and 3 | Pre-dose and , 3, 20 and 60 minutes post-dose (Study Visits 1 and 3) |
| Albuterol HFA usage for rescue relief of acute asthma symptoms | Evaluation Albuterol HFA usage for rescue relief of acute asthma symptoms | Study Visits 1, 2, and 3, within 30 min predose |
| Orange |
| California |
| 92868 |
| United States |
| Amphastar Site 4 | Stockton | California | 95207 | United States |
| Amphastar Site 2 | Medford | Oregon | 97504 | United States |
| Amphastar Site 1 | Portland | Oregon | 97202 | United States |
| Amphastar Site 7 | North Charleston | South Carolina | 29406 | United States |
| Amphastar Site 3 | El Paso | Texas | 79903 | United States |
| Amphastar Site 6 | San Antonio | Texas | 78229 | 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. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |