4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma

PHASE3TerminatedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Asthma
Interventions
DRUG

Armstrong Albuterol Sulfate Inhalation Aerosol

Albuterol Sulfate Inhalation Aerosol, 216 mcg albuterol sulfate (108 mcg/actuation) is equivalent to 180 mcg albuterol base (90 mcg/actuation).

DRUG

Albuterol Sulfate Inhalation Aerosol

Albuterol Sulfate Inhalation Aerosol, 216 mcg albuterol sulfate (108 mcg/actuation) is equivalent to 180 mcg albuterol base (90 mcg/actuation).

Trial Locations (8)

75231

Pharmaceutical Research & Consulting, Inc., Dallas

90806

West Coast Clinical Trials Phase 2-4, LLC, Long Beach

92120

Allergy Associates Medical Group, Inc., San Diego

95207

Bensch Research Associates, Stockton

97213

Allergy Associates Research Center, Portland

97401

Allergy and Asthma Research Group, Eugene

97504

Clinical Research Institute of Southern Oregon, Medford

97520

Integrated Medical Research, Ashland

All Listed Sponsors
lead

Amphastar Pharmaceuticals, Inc.

INDUSTRY