Overview

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

Status:
Completed

Trial end date:
2018-05-31

Target enrollment:

Participant gender:

Summary

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).

Phase:

Phase 3

Details

Lead Sponsor:

Actavis Inc.

Collaborator:

Teva Pharmaceuticals USA

Treatments:

Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Formoterol Fumarate