NCT01357642

Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 373 (actual)
• Sponsor: Amphastar Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Epinephrine inhalation aerosol	Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals
DRUG	Placebo	Placebo for epinephrine inhalation aerosol, formulation without epinephrine
DRUG	epinephrine inhalation aerosol	epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2011-05-23
• Last updated: 2016-03-11

Locations

33 sites across 1 country: United States