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

NCT05735431 | Withdrawn Phase 3

• 1 other identifier: EF182
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moderate Asthma

Outcome Measures

Primary Outcomes (1)

• Absolute change in pre-bronchodilator Forced expiratory volume in one second - Liter, assessed by means of pulmonary function testing 12 weeks after initiation of treatment (Final visit) from baseline (Randomization visit)

  Absolute change in pre-bronchodilator Forced expiratory volume in one second - Liter, assessed by means of pulmonary function testing 12 weeks after initiation of treatment (Final visit) from baseline (Randomization visit). The interval between visits is 28 ± 2 days.

  of pulmonary function testing 12 weeks after initiation of treatment (Final visit) from baseline (Randomization visit).

Secondary Outcomes (3)

• Secondary Efficacy Endpoints - treatment progress

  Evolution of the pre-bronchodilator Forced expiratory volume in one second - Liter value throughout the treatment (Randomization visit, Visit 1, Visit 2, and Final visit);

• Secondary Efficacy Endpoints - treatment progress

  Peak expiratory flow value (Liter/minute) measured in the morning and in the afternoon throughout the treatment (Randomization visit, Visit 1, Visit 2, and Final visit);

• Secondary Efficacy Endpoints - treatment progress

  Final Asthma Control Questionnaire 7 score 12 weeks after starting treatment (Randomization visit, Visit 1, Visit 2, and Final visit)

Study Arms (2)

Formoterol 6 mcg/fluticasone 125 mcg

EXPERIMENTAL

Formoterol 6 mcg/fluticasone 125 mcg Eurofarma.

Drug: Administration of investigation drug

Alenia® 6 mcg/200 mcg

ACTIVE COMPARATOR

Alenia® 6 mcg/200 mcg.

Drug: Administration of comparator

Interventions

Administration of investigation drug DRUG

Participants randomized to this group will receive 1 inhalation of the product, twice daily, for 12 weeks.

Also known as: Formoterol 6 mcg/fluticasone 125 mcg

Formoterol 6 mcg/fluticasone 125 mcg

Administration of comparator DRUG

Participants randomized to this group will receive 1 inhalation of the product, twice daily, for 12 weeks.

Also known as: Alenia® 6 mcg/200 mcg

Alenia® 6 mcg/200 mcg

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Eurofarma Laboratorios S.A

São Paulo, 06696-000, Brazil

Location

MeSH Terms

Interventions

Formoterol Fumarate; Fluticasone

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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: Enrolled participants will be randomized to one of the following treatment groups: Investigational Group: Formoterol 6 mcg/fluticasone 125 mcg Eurofarma. Participants randomized to this group will receive 1 inhalation of the product, twice daily, for 12 weeks. Comparator Group: Alenia® 6 mcg/200 mcg. Participants randomized to this group will receive 1 inhalation of the product, twice daily, for 12 weeks.

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: February 21, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-05

Locations

BR (1)