A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Budesonide; Formoterol Fumarate

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.