Status:
COMPLETED
Evaluation of Efficacy and Safety of E004 in Children With Asthma
Lead Sponsor:
Amphastar Pharmaceuticals, Inc.
Conditions:
Asthma
Eligibility:
All Genders
4-11 years
Phase:
PHASE3
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01460511
Start Date
October 1 2011
End Date
July 1 2012
Last Update
July 31 2018
Active Locations (8)
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1
Amphastar Site 5
Costa Mesa, California, United States, 92626
2
Amphastar Site 8
Orange, California, United States, 92868
3
Amphastar Site 4
Stockton, California, United States, 95207
4
Amphastar Site 2
Medford, Oregon, United States, 97504