NCT02495168

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,714 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a pivotal trial that will examine the therapeutic equivalence of a new generic fixed-dose combination product containing budesonide 80 μg/formoterol fumarate dihydrate 4.5 μg and reference listed drug (RLD) Symbicort® inhalation aerosol in adult participants with chronic but stable asthma as defined in National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP 3) guidelines. To ensure adequate study sensitivity, the test and reference products should both be statistically superior to placebo (p\<0.05) with regard to the bioequivalent study primary endpoints. Participants will be provided a generic placebo pressurized metered-dose inhaler (pMDI) device for use during the 2-week Run-in Period for device training.

Conditions

• Asthma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-13
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2015-07-13
• Last updated: 2019-11-29
• Results posted: 2019-11-29

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study