NCT07318350

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

Phase 3, Multicenter, Randomized, Parallel-group, Open-label, Non-inferiority Study of N0783 Versus Comparator (Formoterol 6 mcg / Budesonide 200 mcg) in the Treatment of Moderate Asthma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Moderate Asthma

Interventions

Type	Name	Description
DRUG	N0783	N0783 is a fixed-dose combination administered via inhalation using a metered-dose inhaler. Participants will receive the study drug according to the dosing regimen specified in the protocol for the treatment of moderate asthma.
DRUG	Alenia® (Formoterol 6 mcg / Budesonide 200 mcg)	Alenia® is a fixed-dose combination of Formoterol 6 mcg and Budesonide 200 mcg administered via inhalation using a metered-dose inhaler. Participants will receive the comparator drug according to the dosing regimen specified in the protocol for the treatment of moderate asthma.

Timeline

• Start date: 2026-10-01
• Primary completion: 2028-03-01
• Completion: 2028-09-01
• First posted: 2026-01-06
• Last updated: 2026-01-07