Non-Inferiority,Combination Formoterol/FluticasonexAlenia®Formoterol/Budesonide for Asthma in Brazil

• Status: Not yet recruiting
• Trial end date: 2026-02-28
• Target enrollment: 0
• Participant gender: All

Summary

Eurofarma Laboratórios S.A. markets a FDC containing formoterol 12 mcg/fluticasone 250 mcg, in a single capsule for inhalation (Lugano®; reference product). The product is indicated for the treatment of asthma in patients aged ≥ 12 years. The company seeks to register a product with lower concentrations of mono-drugs (6 mcg and 125 mcg, respectively) to enable the dosage step up and step down treatment strategies advocated by the Global Initiative for Asthma for the inhaled maintenance treatment of asthma (GINA, 2022 ) with these combinations.

This Phase 3 study will be carried out for demonstrating the non-inferiority of the investigational drug (FDC of formoterol 6 mcg/fluticasone 125 mcg) compared to the FDC of formoterol 6 mcg/budesonide 200 mcg (Alenia® - Aché Laboratórios Farmacêuticos S.A.) in the maintenance treatment of asthma, allowing its registration as a new concentration of the drug already registered by the company.

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

Details

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

Criteria

Inclusion Criteria:

Patients of both sexes who meet all of the following criteria will be included in the study:

• Signature of the Informed Consent Term (ICF) for people over 18 years and, when applicable, signature of the Informed Assent Form (IAF) by the participant under 18 years of age and the ICF by the representative before carrying out any study procedure.

• Age ≥ 12 years.

• History of recurrent symptoms suggestive of asthma (cough, wheezing, shortness of breath, and/or chest tightness).

• Previous medical diagnosis of asthma.

Exclusion Criteria:

Patients who meet at least one of the following criteria will be excluded from the study:

• Occurrence of moderate to serious asthma exacerbation within 90 days prior to initiation of study treatment.

• Presence of acute or chronic symptomatic respiratory tract infection.

• Body mass index (BMI) ≥ 38 kg/m2.

• Use of long-acting anticholinergic drug (LAMA) in the last six (06) months.