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NCT01476904 · ClinicalTrials.gov registry record · Phase 3

Safety Study in Adolescent and Adult Patients With Asthma

A Phase 3 study, sponsored by Amphastar Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
208
Enrollment target

NCT01476904: Completed Phase 3 study, sponsored by Amphastar Pharmaceuticals.

NCT01476904 is a Phase 3 study that has completed, run by Amphastar Pharmaceuticals. The registered enrollment target is 208 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01476904, a Phase 3 study, has completed, sponsored by Amphastar Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
208 participants
Enrollment target

Study 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.

Primary Outcome

Recording of all adverse events experienced during the course of the study

Interventions

  • DRUG Placebo
  • DRUG Primatene Mist
  • DRUG Epinephrine inhalation

Trial Details

FieldValue
Enrollment Target 208 participants
Start Date 2011-11
Est. Completion 2012-07
Phase Phase 3
Amphastar Pharmaceuticals

21 total trials

What the finished NCT01476904 record still lists

NCT01476904 is an interventional study that assigns participants to a tested intervention. The registered 208 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 (73% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01476904 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01476904 about?

NCT01476904 is a clinical study titled "Safety Study in Adolescent and Adult Patients With Asthma". 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.

What is the current status of trial NCT01476904?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 2011-11. Estimated completion is 2012-07.

What interventions are being tested in trial NCT01476904?

The interventions under investigation include: Placebo (DRUG), Primatene Mist (DRUG), Epinephrine inhalation (DRUG).

Who is sponsoring clinical trial NCT01476904?

This trial is sponsored by Amphastar Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01476904's enrollment target sits among peer trials

208 1345th of 2000 higher than 655 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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Source: ClinicalTrials.gov NCT01476904, the US trial registry maintained by the National Library of Medicine. NCT01476904 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.