Evaluation of Efficacy and Safety of E004 in Children With Asthma
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 4 - 11 |
Updated: | 8/2/2018 |
Start Date: | October 2011 |
End Date: | July 2012 |
Phase III Study of Epinephrine Inhalation Aerosol for Evaluation of Efficacy and Safety of E004 in Children With Asthma
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.
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.
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.
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