Asthma
Conditions
Keywords
Mild bronchial asthma
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.
Interventions
DRUGE004 (Epinephrine Inhalation Aerosol) HFA-MDI
E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID
DRUGPlacebo-HFA
Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
Sponsors
Amphastar Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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. |
Countries
United States
Outcome results
None listed