A Phase 3 interventional study of E004 (Epinephrine Inhalation Aerosol) HFA-MDI and Placebo-HFA in Asthma, sponsored by Amphastar Pharmaceuticals, Inc.. Completed at 8 sites in United States. Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2018-07-31.
Sponsored by Amphastar Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 70 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Amphastar Pharmaceuticals, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
Drug: Placebo-HFA
E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID
Drug: E004 (Epinephrine Inhalation Aerosol) HFA-MDI
E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID
Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
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%.
Time frame: Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose
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
Time frame: Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose
Maximum of change in FEV1% (Fmax)
Evaluation of maximum percent change in FEV1
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Study Visits 1, 2, and 3, within 30 min predose
The record gives a start of Oct 2011, a primary completion of Mar 2012 and a completion of Jul 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Amphastar Pharmaceuticals, Inc.