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Completed
NCT04233190
A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment
Conditions: Asthma Copd
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 472
Sponsor: Eurofarma Laboratorios S.A.
Location: Eurofarma Laboratorios S.A São Paulo São Paulo
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).
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Occurrence of asthma exacerbation within 30 days prior to initiation of study treatment.
* Presence of acute or chronic symptomatic airway infection.
Source: ClinicalTrials.gov (NCT04233190). StuddyBuddy aggregates publicly available trial information.
