Clinical Trial

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

Study acronym: FORASMA
Not Yet Recruiting Phase 3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-23.
Trial Details
NCT Number NCT07318350
Lead Sponsor Eurofarma Laboratorios S.A.
Conditions Moderate Asthma
Enrollment 174 participants
Start Date 2026-10
Primary Completion 2028-03 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-01-07