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

Eurofarma

Status and phase: Completed; Phase 3

Conditions: Asthma Copd

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04233190

EF162

Details and patient eligibility

About

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).

Full 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).

Enrollment: 472 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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472 participants in 2 patient groups

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

Experimental group

Description:

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

Alenia® (12/400mcg e 6/200mcg)

Active Comparator group

Description:

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

Treatment:

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