Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2028-09-01

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

Eurofarma Laboratorios S.A.

Treatments:

Budesonide
Formoterol Fumarate