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NCT01357642 · ClinicalTrials.gov registry record · Phase 3
Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients
A Phase 3 study, sponsored by Amphastar Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 373
- Enrollment target
NCT01357642: Completed Phase 3 study, sponsored by Amphastar Pharmaceuticals.
NCT01357642 is a Phase 3 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 373 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01357642, a Phase 3 study, has completed, sponsored by Amphastar Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 373 participants
- Enrollment target
Study Summary
This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist (epinephrine CFC inhaler), in adolescent and adult subjects with asthma.
Primary Outcome
Serial FEV1 measurements to demonstrate the mean AUC of change in percent FEV1 from same-day baseline of E004 (Treatment T; Epinephrine-HFA) versus Placebo-HFA (Treatment P) is the primary efficacy endpoint.
Interventions
- DRUG Placebo
- DRUG epinephrine inhalation aerosol
- DRUG Epinephrine inhalation aerosol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 373 participants |
| Start Date | 2011-07 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
What the finished NCT01357642 record still lists
NCT01357642 is an interventional study that assigns participants to a tested intervention. The registered 373 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01357642 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01357642 about?
NCT01357642 is a clinical study titled "Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients". This clinical study evaluates the 12-week efficacy and safety of Epinephrine HFA Inhalation Aerosol HFA the proposed HFA formulation of metered dose inhaler (MDI) of Epinephrine, in comparison to a Placebo-HFA control MDI and the currently marketed Primatene® Mist (epinephrine CFC inhaler), in adole...
What is the current status of trial NCT01357642?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 373 participants. The study started on 2011-07. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01357642?
The interventions under investigation include: Placebo (DRUG), epinephrine inhalation aerosol (DRUG), Epinephrine inhalation aerosol (DRUG).
Who is sponsoring clinical trial NCT01357642?
This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01357642's enrollment target sits among peer trials
373 991st of 2000 higher than 1,010 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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