drugset / Trial / NCT01167010

A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma

NCT01167010 ↗

Phase 3 Completed 552 enrolled Eurofarma Laboratorios S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective will be to compare the Eurofarma and Alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.

Timeline

Start
2011-04
Primary completion
2011-08
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 400 ug —
Subject Formoterol Other / unclassified 12 ug —

Indications