NCT01025648View on ClinicalTrials.gov

Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Asthma
Interventions
DRUG

E004 (epinephrine inhalation aerosol), 90 mcg/actuation

E004 (epinephrine inhalation aerosol), 90 mcg/actuation, 2 actuations, single dose crossover, 1 -14 day washout period

DRUG

E004 Placebo

E004 Placebo, 0 mcg epinephrine inhalation aerosol, 2 actuations, 1 -14 day washout period

DRUG

E004 (epinephrine inhalation aerosol), 125 mcg

E004 (epinephrine inhalation aerosol), 125 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 day washout period

DRUG

E004 (epinephrine inhalation aerosol), 220 mcg

E004 (epinephrine inhalation aerosol), 220 mcg - 220 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 days washout period

DRUG

epinephrine inhalation aerosol, CFC propelled

epinephrine inhalation aerosol, 220 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 day washout period

DRUG

E004 (epinephrine inhalation aerosol), 160 mcg

E004 (epinephrine inhalation aerosol), 160 mcg/actuation, 2 actuations, single dose crossover, 1 - 14 days washout period

Trial Locations (2)

95117

Amphastar Site 0001, San Jose

95207

Amphastar Site 0003, Stockton

Sponsors
All Listed Sponsors
lead

Amphastar Pharmaceuticals, Inc.

INDUSTRY