Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Asthma
Interventions
DRUG

Albuterol Spiromax

Albuterol Spiromax® Inhalation Aerosol contains 90 mcg albuterol per actuation orally inhaled in a single dose dry powder inhaler (DPI). Participants took doses at either the 90 or 180 mcg levels. If the higher level, two DPIs filled with Albuterol Spiromax® were used.

DRUG

ProAir HFA

ProAir® HFA Inhalation Aerosol contains 90 mcg albuterol per actuation orally inhaled in a single dose metered dose inhaler (MDI). Participants took doses at either the 90 or 180 mcg levels. If the higher level, two MDIs filled with ProAir HFA were used.

DRUG

Placebo

Single dose MDIs and DPIs containing placebo taken as a single orally-inhaled actuation each.

Trial Locations (22)

Unknown

Teva Investigational Site 10598, Birmingham

Teva Investigational Site 10593, Little Rock

Teva Investigational Site 10610, Costa Mesa

Teva Investigational Site 10582, Huntington Beach

Teva Investigational Site 10606, Orange

Teva Investigational Site 10597, San Jose

Teva Investigational Site 10596, Jacksonville

Teva Investigational Site 10599, Lawrenceville

Teva Investigational Site 10580, Savannah

Teva Investigational Site 10592, Normal

Teva Investigational Site 10602, Missoula

Teva Investigational Site 10578, Raleigh

Teva Investigational Site 10577, Oklahoma City

Teva Investigational Site 10589, Medford

Teva Investigational Site 10604, Portland

Teva Investigational Site 10591, Charleston

Teva Investigational Site 10609, Orangeburg

Teva Investigational Site 10579, Spartanburg

Teva Investigational Site 10588, Boerne

Teva Investigational Site 10605, New Braunfels

Teva Investigational Site 10583, San Antonio

Teva Investigational Site 10576, Waco

All Listed Sponsors
lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

NCT01899144 - Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients | Biotech Hunter | Biotech Hunter