Evaluation of Efficacy and Safety of E004 in Children With Asthma
- Conditions
- Asthma
- Interventions
- Drug: E004 (Epinephrine Inhalation Aerosol) HFA-MDIDrug: Placebo-HFA
- Registration Number
- NCT01460511
- Lead Sponsor
- Amphastar Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Generally healthy male, and premenarchal female, children aged 4 - 11 years upon Screening.
- With documented asthma, requiring inhaled epinephrine or beta2-agonist treatment, with or without concurrent anti-inflammatory therapies for at least 6-months prior to Screening.
- Being capable of performing spirometry for FEV1
- Satisfying criteria of asthma
- Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods
- Demonstrating a Screening Baseline FEV1 that is 50 - 90% of Polgar predicted normal value.
- Demonstrating an Airway Reversibility,
- Demonstrating satisfactory techniques in the use of a metered-dose inhaler (MDIs) and a hand held peak expiratory flow meter, after training.
- Has been properly consented to participate in this study.
- Any current or past medical conditions that, per investigator discretion, might significantly affect pharmacodynamic responses to the study drugs
- Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases.
- Known intolerance or hypersensitivity to any component of the study drugs
- Recent infection of the respiratory tract
- Use of prohibited medications
- Having been on other investigational drug/device studies in the last 30 days prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description T - E004 (Epinephrine Inhalation Aerosol) HFA-MDI E004 (Epinephrine Inhalation Aerosol) HFA-MDI E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID P - Placebo-HFA Placebo-HFA Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoint AUC of FEV1's relative change Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose bronchodilator effect expressed as AUC of FEV1's relative change (from the same day baseline) versus time, defined as AUC of ΔFEV1%.
- Secondary Outcome Measures
Name Time Method AUC of FEV1 volume changes (AUC of change in FEV1) Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose determination of the change in FEV1 from baseline at visit to to post treatment at Visit 3
Maximum of change in FEV1% (Fmax) Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose Evaluation of maximum percent change in FEV1
Time to onset of bronchodilator effect (to onset), determined the time point (within 60 minutes) where FEV1 first reaches ≥12% above Same-Day Baseline. Study Visits 1and 3 within 60 minutes post dose Evaluation of how much time elapses (within 60 minutes), until FEV1 first reaches ≥12% above Same-Day Baseline.
Albuterol HFA usage for rescue relief of acute asthma symptoms Study Visits 1, 2, and 3, within 30 min predose Evaluation Albuterol HFA usage for rescue relief of acute asthma symptoms
The time to peak FEV1 effect (tmax), defined as the time of Fmax. Study Visits 1 and 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose Evaluation of how much time elapses until FEV1 reaches its peak
Curves of change in FEV1, and change in FEV1%, versus time Visit 1 and Visit 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose Evaluation of curves of change in FEV1 and percent change in FEV1 over time
Duration of efficacy (duration), defined as the total length of time when ΔFEV1% reaches and stays ≥12% above Same-Day Baseline. Study Weeks 1and 3 at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose Evaluation of the total length of time it takes until the change in FEV1% reaches and stays ≥12% above Same-Day Baseline.
Percentage of positive responders (R%), including all subjects whose Fmax reaches ≥12% above Same-Day Baseline. Study Weeks 1 and 3 within 60 minutes post dose Evaluation of what percentage of subjects are positive responders (R%), including all subjects whose Fmaxreaches ≥12% above Same-Day Baseline.
Mean daily morning pre-dose Peak Expiratory Flow Rate (PEF) daily pre-dose Evaluation of the mean of daily morning pre-dose Expiratory Flow Rate
Evaluation of Vital Signs predose, and 3, 20, 60, 360 minutes post-dose 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
12-lead ECG Pre-dose and , 3, 20 and 60 minutes post-dose (Study Visits 1 and 3) 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
Trial Locations
- Locations (8)
Amphastar Site 6
🇺🇸San Antonio, Texas, United States
Amphastar Site 7
🇺🇸North Charleston, South Carolina, United States
Amphastar Site 8
🇺🇸Orange, California, United States
Amphastar Site 2
🇺🇸Medford, Oregon, United States
Amphastar Site 5
🇺🇸Costa Mesa, California, United States
Amphastar Site 3
🇺🇸El Paso, Texas, United States
Amphastar Site 4
🇺🇸Stockton, California, United States
Amphastar Site 1
🇺🇸Portland, Oregon, United States