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

NCT02495168 PHASE3 COMPLETED Results posted

This study has a randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week open placebo Run-in Period followed by a 6-week Treatment Period with placebo, test product (budesonide 80 microgram \[μg\]/formoterol fumarate dihydrate 4.5 μg), or reference product (Symbicort® inhalation aerosol).

Details

Lead sponsor	Actavis Inc.
Phase	PHASE3
Status	COMPLETED
Enrolment	1714
Start date	Fri Jan 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu May 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Asthma

Interventions

• Generic Budesonide/Formoterol Fumarate Dihydrate
• Symbicort® (Budesonide/Formoterol Fumarate Dihydrate)
• Placebo

Countries

United States