Trials / Completed
CompletedNCT01476904
Safety Study in Adolescent and Adult Patients With Asthma
A 3-month Safety Evaluation Extension to the 12-week E004-C Study in Asthma Patients (A Double Blinded, Placebo-controlled, Parallel, 3-month Safety Study in Adolescent and Adult Patients With Asthma)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 208 (actual)
- Sponsor
- Amphastar Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 12 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
E004-C2 is a continuation of E004-C for safety evaluations with additional 3 months to be able to assess the 6-month safety profile for E004 (epinephrine inhalation) versus placebo in a double-blinded manner.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | 0 mcg/inhalation, 2 inhalations QID |
| DRUG | Primatene Mist | 220 mcg/inhalation, 2 inhalations QID |
| DRUG | Epinephrine inhalation | 125 mcg/inhalation, 2 inhalations QID |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2012-04-01
- Completion
- 2012-07-01
- First posted
- 2011-11-22
- Last updated
- 2017-02-13
Locations
27 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01476904. Inclusion in this directory is not an endorsement.