drugset / Trial / NCT04233190

A Multicenter, Randomized, Parallel, Two-period, Non-inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment

NCT04233190

Phase 3 Completed 472 enrolled Eurofarma Laboratorios S.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

A phase III study, multicenter, randomized, parallel, open, two-period, comparative non-inferiority of Eurofarma versus Alenia® in the treatment of moderate to severe persistent asthma with and without obstructive pulmonary disease (COPD). ⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Timeline

Start
2023-04-19
Primary completion
2024-10-28
Completion
2024-10-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule 200 ug Inhaled
Comparator Budesonide Small molecule 400 ug Inhaled
Comparator Formoterol Other / unclassified 6 ug Inhaled
Comparator Formoterol Other / unclassified 12 ug Inhaled

Indications