At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter, Multinational Study to Compare the Therapeutic Equivalence of a Budesonide 80 μg/Formoterol Fumarate Dihydrate 4.5 μg Inhalation Aerosol (Manufactured by Catalent for Watson Laboratories Inc.) to Symbicort® (Budesonide 80 μg/Formoterol Fumarate Dihydrate 4.5 μg Inhalation Aerosol) (Manufactured by AstraZeneca) in Adolescent and Adult Patients With Asthma
In Brief
A Phase 3 clinical trial evaluating Generic Budesonide/Formoterol Fumarate Dihydrate, Symbicort® (Budesonide/Formoterol Fumarate Dihydrate), and 1 other intervention for Asthma. Completed, enrolled 1,714 participants across 17 sites.
Detailed 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).
Study Details
Timeline
Interventions
Oral inhalation, generic formulation of the brand-name product.
Oral inhalation, brand-name product.
Oral inhalation, no active ingredient.