NCT04233190CompletedPhase 3
A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 472 (actual)
- First submitted
- 15 Jan 2020
- Start date
- Apr 2023
- Primary completion date
- Oct 2024
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Diseases
- Asthma
- NCT number
- NCT04233190
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 472
- From Apr 2023 to the primary completion date, Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Occurrence of asthma exacerbation within 30 days prior to initiation of study treatment.
Other illness
- Presence of acute or chronic symptomatic airway infection.
Who the study is looking for
- Age ≥ 12 years
- Presence of moderate to severe persistent asthma according to Global Initiative for Asthma (GINA) 1 criteria for at least 1 year, clinically stable (controlled) for at least 30 days.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eurofarma Laboratorios S.A Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.