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NCT01460511 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Efficacy and Safety of E004 in Children With Asthma
A Phase 3 study of Asthma, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
- 8
- Study locations
NCT01460511: Completed Phase 3 study of Asthma, sponsored by Amphastar Pharmaceuticals.
NCT01460511 is a Phase 3 study of Asthma that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 70 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01460511, a Phase 3 study of Asthma, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
bronchodilator effect expressed as AUC of FEV1's relative change (from the same day baseline) versus time, defined as AUC of ΔFEV1%.
Conditions Studied
Interventions
- DRUG E004 (Epinephrine Inhalation Aerosol) HFA-MDI
- DRUG Placebo-HFA
Study Locations (8)
California
- Amphastar Site 5 - Costa Mesa
- Amphastar Site 8 - Orange
- Amphastar Site 4 - Stockton
Oregon
- Amphastar Site 2 - Medford
- Amphastar Site 1 - Portland
Texas
- Amphastar Site 3 - El Paso
- Amphastar Site 6 - San Antonio
South Carolina
- Amphastar Site 7 - North Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
What the finished NCT01460511 record still lists
NCT01460511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which E004 (Epinephrine Inhalation Aerosol) HFA-MDI is the first listed.
NCT01460511 lists 8 locations in 4 states (California, Oregon, Texas).
Frequently Asked Questions
What is clinical trial NCT01460511 about?
NCT01460511 is a clinical study titled "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.
What is the current status of trial NCT01460511?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2011-10. Estimated completion is 2012-07.
What conditions does trial NCT01460511 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01460511?
The interventions under investigation include: E004 (Epinephrine Inhalation Aerosol) HFA-MDI (DRUG), Placebo-HFA (DRUG).
Who is sponsoring clinical trial NCT01460511?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01460511 being conducted?
This trial has 8 study locations across California, Oregon, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01460511's enrollment target sits among peer trials
70 240th of 374 higher than 132 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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