Study of Formoterol 6 mcg/Fluticasone 125 mcg by Eurofarma Laboratórios S.A. Versus Alenia® 6 mcg/200 mcg in Patients With Asthma (FORASMA)

Summary

This is a Phase 3, multicenter, randomized, parallel-group, open-label, non-inferiority clinical trial designed to evaluate the efficacy and safety of N0783 compared to Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) in the treatment of moderate asthma. Adult patients diagnosed with moderate asthma according to clinical and functional criteria will be enrolled. The primary objective is to demonstrate that N0783 is not inferior to Alenia® in improving asthma control. Participants will receive treatment according to the assigned intervention and will be monitored through scheduled visits for assessment of lung function, symptom control, and safety parameters throughout the study period.

Timeline

Start

2026-10

Primary completion

2028-03

Completion

2028-09

Drugs

Indications

No indication recorded.