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

NCT ID: NCT04233190

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 472 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-19
• Study Completion Date: 2024-10-30

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).

Detailed Description

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).

Conditions

Asthma Copd

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

No interventions assigned to this group

Alenia® (12/400mcg e 6/200mcg)

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

one inhalation, twice daily

Interventions

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

one inhalation, twice daily

Intervention Type: DRUG

Other Intervention Names

fumarato de formoterol di-hidratado 12mcg + budesonida 400mcg/fumarato de formoterol di-hidratado 62mcg + budesonida 200mcg

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurofarma Laboratorios S.A

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EF162

Identifier Type: -

Identifier Source: org_study_id