Non-Inferiority,Combination Formoterol/FluticasonexAlenia®Formoterol/Budesonide for Asthma in Brazil
Status:
Not yet recruiting
Trial end date:
2026-02-28
Target enrollment:
Participant gender:
Summary
Eurofarma Laboratórios S.A. markets a FDC containing formoterol 12 mcg/fluticasone 250 mcg,
in a single capsule for inhalation (Lugano®; reference product). The product is indicated for
the treatment of asthma in patients aged ≥ 12 years. The company seeks to register a product
with lower concentrations of mono-drugs (6 mcg and 125 mcg, respectively) to enable the
dosage step up and step down treatment strategies advocated by the Global Initiative for
Asthma for the inhaled maintenance treatment of asthma (GINA, 2022 ) with these combinations.
This Phase 3 study will be carried out for demonstrating the non-inferiority of the
investigational drug (FDC of formoterol 6 mcg/fluticasone 125 mcg) compared to the FDC of
formoterol 6 mcg/budesonide 200 mcg (Alenia® - Aché Laboratórios Farmacêuticos S.A.) in the
maintenance treatment of asthma, allowing its registration as a new concentration of the drug
already registered by the company.