Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants

PHASE3CompletedINTERVENTIONAL
Enrollment

1,714

Participants

Timeline

Start Date

January 13, 2017

Primary Completion Date

May 31, 2018

Study Completion Date

May 31, 2018

Conditions
Asthma
Interventions
DRUG

Generic Budesonide/Formoterol Fumarate Dihydrate

Oral inhalation, generic formulation of the brand-name product.

DRUG

Symbicort® (Budesonide/Formoterol Fumarate Dihydrate)

Oral inhalation, brand-name product.

DRUG

Placebo

Oral inhalation, no active ingredient.

Trial Locations (17)

Unknown

Site 100, Surprise

Site 101, Huntington Beach

111, San Jose

114, Centennial

104, Hialeah

103, Miami

105, Miami

107, Miami

106, Bozeman

113, Bellevue

112, Cincinnati

108, Edmond

115, Eugene

116, Medford

110, Rock Hill

109, Smyrna

102, Waco

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Teva Pharmaceuticals USA

INDUSTRY

lead

Actavis Inc.

INDUSTRY

NCT02495168 - Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants | Biotech Hunter | Biotech Hunter