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

Asthma Copd Clinical Trial

— ESPIRE  

Official title:

A Randomized, Parallel-Group, Open, Two-Period, Comparative Non-Inferiority Study of Eurofarma's Formoterol/Budesonide vs Alenia in the Treatment of Moderate to Severe Persistent Asthma With and Without Chronic Obstructive Pulmonary COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04233190
• Other study ID #: EF162
• Status: Recruiting
• Phase: Phase 3
• Start date: April 19, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: May 2024
• Source: Eurofarma Laboratorios S.A.
• Contact: Gleyce Lima
• Phone: 55 11 5090 8411
• Email: gleyce.lima[@]eurofarma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 472
• Est. completion date: November 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma Copd

Intervention

Drug:
• Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg
one inhalation, twice daily

Locations

Country	Name	City	State
Brazil	Eurofarma Laboratorios S.A	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1	Average change from baseline in pre-dose Forced Expiratory Volume in one second	24 weeks