Last updated on July 2019

Randomized Placebo-controlled Multi-dose Study Comparing Budesonide/Formoterol to Symbicort in Asthmatic Patients

Brief description of study

A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide 80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort inhalation aerosol.

Detailed Study Description

This is a pivotal trial that will examine therapeutic equivalence of a new generic fixed-dose combination product containing Budesonide 80 mcg / Formoterol fumarate dihydrate 4.5 mcg and reference listed drug (RLD) Symbicort inhalation aerosol in adult patients 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.

Clinical Study Identifier: NCT02495168

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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