drugset / Trial / NCT03015259

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

NCT03015259 ↗

Phase 3 Completed 1762 enrolled Kindeva Drug Delivery
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2016-12-29
Primary completion
2018-02-08
Completion
2018-02-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 0.08 mg Inhaled
Subject Formoterol Other / unclassified 0.0045 mg Inhaled

Indications