Who is sponsoring NCT01357642?

NCT01357642 is sponsored by Amphastar Pharmaceuticals, Inc..

What drugs are being tested in NCT01357642?

Interventions: Epinephrine inhalation aerosol, Placebo, epinephrine inhalation aerosol.

What is the status of NCT01357642?

NCT01357642 is currently COMPLETED.

Last reviewed 2016-02-11 · How we verify

Epinephrine Inhalation Aerosol USP, an HFA-MDI: Clinical Study-C For Evaluation Of Efficacy And Safety In Asthma Patients

NCT01357642 Phase 3 COMPLETED

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.

Details

Lead sponsor	Amphastar Pharmaceuticals, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	373
Start date	2011-07
Completion	2011-12

Conditions

Asthma

Interventions

Epinephrine inhalation aerosol
Placebo
epinephrine inhalation aerosol

Primary outcomes

Change in Area Under the Curve (AUC) versus placebo — at 5, 30, 60, 120, 180, 240, and 360 minutes post-dose
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.

Countries

United States