Trials / Completed
CompletedNCT01460511
Evaluation of Efficacy and Safety of E004 in Children With Asthma
Phase III Study of Epinephrine Inhalation Aerosol for Evaluation of Efficacy and Safety of E004 in Children With Asthma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Amphastar Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 4 Years – 11 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E004 (Epinephrine Inhalation Aerosol) HFA-MDI | E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID |
| DRUG | Placebo-HFA | Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2012-03-01
- Completion
- 2012-07-01
- First posted
- 2011-10-27
- Last updated
- 2018-07-31
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01460511. Inclusion in this directory is not an endorsement.