A Phase 3 interventional study of Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg in Asthma Copd, sponsored by Eurofarma Laboratorios S.A.. Completed at 1 site in Brazil. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Eurofarma Laboratorios S.A. · Phase 3, Interventional, and Treatment
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).
In the first study period (Period 1), patients with moderate to severe persistent asthma according to GINA criteria, with or without COPD, will be randomized at a 1: 1 ratio to receive formoterol 12mcg / budesonide 400mcg Eurofarma or Alenia® 12mcg / 400mcg during 12 weeks Participants who maintain asthma control at the end of this treatment period (no more than one exacerbation during this period) will be included in Period 2, in which the dose of each investigational product will be reduced (step-down), and the patients will receive formoterol 6mcg / budesonide 200mcg Eurofarma or Alenia® 6mcg / 200mcg, respectively, for an additional 12 weeks. The primary non-inferiority assessment will be performed at the end of 24 weeks of treatment, with intermediate assessment at the end of week 12.
The study will be conducted in an open label since the devices for inhalation of products have different aspects, making it impossible to blind the treatments of the study. The primary efficacy variable (forced expiratory volume in one second [FEV1]) minimizes the potential bias arising from the open label of the study.
⚠️study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Eurofarma Laboratorios S.A. is the lead sponsor of 64 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Formoterol 12mcg + budesonide 400mcg / Formoterol 6mcg + budesonide 200mcg
Drug: Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg
Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg
Drug: Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg
one inhalation, twice daily
Also known as: fumarato de formoterol di-hidratado 12mcg + budesonida 400mcg/fumarato de formoterol di-hidratado 62mcg + budesonida 200mcg
FEV1
Average change from baseline in pre-dose Forced Expiratory Volume in one second
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Eurofarma Laboratorios S.A.