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Study of Formoterol 6 mcg/Fluticasone 125 mcg by Eurofarma Laboratórios S.A. Versus Alenia® 6 mcg/200 mcg in Patients With Asthma (FORASMA)
Sponsor: Eurofarma Laboratorios S.A.
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.
Official title: 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
Key Details
Gender
All
Age Range
12 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
174
Start Date
2026-10
Completion Date
2028-09
Last Updated
2026-01-07
Healthy Volunteers
No
Conditions
Interventions
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.
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.