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A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment
Sponsor: Eurofarma Laboratorios S.A.
Summary
A phase III study, multicenter, randomized, parallel, open, two-period, comparative non-inferiority of Eurofarma versus Alenia® in the treatment of moderate to severe persistent asthma with and without obstructive pulmonary disease (COPD). ⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Official title: A Randomized, Parallel-Group, Open, Two-Period, Comparative Non-Inferiority Study of Eurofarma's Formoterol/Budesonide vs Alenia in the Treatment of Moderate to Severe Persistent Asthma With and Without Chronic Obstructive Pulmonary COPD
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
472
Start Date
2023-04-19
Completion Date
2024-10-30
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg
one inhalation, twice daily
Locations (1)
Eurofarma Laboratorios S.A
São Paulo, São Paulo, Brazil