NCT01737905 is a Phase 3 clinical trial of Epinephrine HFA-MDI (E004) in Asthma, sponsored by Amphastar Pharmaceuticals, Inc..

Who is sponsoring NCT01737905?

NCT01737905 is sponsored by Amphastar Pharmaceuticals, Inc..

What drugs are being tested in NCT01737905?

Interventions in NCT01737905: Epinephrine HFA-MDI (E004), Placebo-HFA.

Is NCT01737905 still recruiting?

NCT01737905 is currently completed. Last updated 11 February 2016.

Last reviewed 2016-02-11 · How we verify

NCT01737905

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma (A Randomized, Double-Blind, Placebo-Controlled, Crossover, Single Dose Study in 4 - 11 Year Old Children With Asthma)

Completed Phase 3 Last updated 11 February 2016

What this trial tests

Phase 3 trial testing Epinephrine HFA-MDI (E004) in Asthma in 28 participants. Completed in 1 December 2013.

Timeline

1 October 2012

Primary endpoint
1 March 2013

1 December 2013

Quick facts

Lead sponsor	Amphastar Pharmaceuticals, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	28
Start date	1 October 2012
Primary completion	1 March 2013
Estimated completion	1 December 2013
Sites	6 locations across United States

Drugs / interventions tested

Epinephrine HFA-MDI (E004) — full drug profile →
Placebo-HFA

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

Amphastar Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 4 to 11, any sex, with Asthma. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Bronchodilator effect
Time frame: up to 30 min pre-dose, postdose up to 3 hours
Bronchodilator effect expressed as AUC of FEV1's relative change from the same day baseline (pre-dose) versus time up to 3 hours, defined as AUC(0-3) of change in FEV1%. The difference of primary endpoints of E004 and Placebo will be evaluated statistically.

Sponsor's own description

This is a multi-center, randomized, double-blinded, placebo-controlled, crossover, single dose study in 24 pediatric patients (4-11 years old) with asthma. The entire study consists of (i) a Screening Visit and (ii) a Study Period with two (2) Study Visits. All study subjects must be properly consented, under adult supervision, and screened against the inclusion and exclusion criteria, at the Screening Visit.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Asthma

Currently open trials in the same condition.

NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t · Phase 2 · recruiting
NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being · NA · recruiting
NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting

Other Amphastar Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT05539872 — Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insu · Phase 2, PHASE3 · completed
NCT04207840 — Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Int · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01737905 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amphastar Pharmaceuticals, Inc.
Last refreshed: 11 February 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01737905.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing