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

NCT04233190 | Completed Phase 3

• 1 other identifier: EF162
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Asthma Copd

Outcome Measures

Primary Outcomes (1)

• FEV1

  Average change from baseline in pre-dose Forced Expiratory Volume in one second

  24 weeks

Study Arms (2)

Formoterol + budesonide Eurofarma (12/400mcg e 6/200mcg)

EXPERIMENTAL

Formoterol 12mcg + budesonide 400mcg / Formoterol 6mcg + budesonide 200mcg

Alenia® (12/400mcg e 6/200mcg)

ACTIVE COMPARATOR

Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg

Drug: Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg

Interventions

Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg DRUG

one inhalation, twice daily

Also known as: fumarato de formoterol di-hidratado 12mcg + budesonida 400mcg/fumarato de formoterol di-hidratado 62mcg + budesonida 200mcg

Alenia® (12/400mcg e 6/200mcg)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Occurrence of asthma exacerbation within 30 days prior to initiation of study treatment.
• Presence of acute or chronic symptomatic airway infection.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Eurofarma Laboratorios S.A

São Paulo, São Paulo, 06696-000, Brazil

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: April 19, 2023
• Primary Completion: October 28, 2024
• Study Completion: October 30, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)