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

NCT ID: NCT05735431

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-30
• Study Completion Date: 2027-11-30

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.

Detailed Description

The investigational drug consists of a fixed-dose combination (FDC) that contains formoterol fumarate dihydrate , a long-acting β2-agonist (LABA), and fluticasone propionate , a glucocorticoid, powder for inhalation contained in a single capsule, in concentrations of 6 mcg and 125 mcg per capsule, respectively. The investigational drug consists of a fixed-dose combination (FDC) that contains formoterol fumarate dihydrate , a long-acting β2-agonist (LABA), and fluticasone propionate , a glucocorticoid, powder for inhalation contained in a single capsule, in concentrations of 6 mcg and 125 mcg per capsule, respectively.The investigational drug consists of a fixed-dose combination (FDC) that contains formoterol fumarate dihydrate , a long-acting β2-agonist (LABA), and fluticasone propionate , a glucocorticoid, powder for inhalation contained in a single capsule, in concentrations of 6 mcg and 125 mcg per capsule, respectively. Multicenter, randomized, parallel-group, open-label, comparative non-inferiority clinical trial. After a run-in period of four (04) weeks, during which all participants will receive Alenia® 6 mcg/200 mcg, patients with moderate asthma (step 3) controlled according to the criteria of the Global Initiative for Asthma (GINA, 20221) will be randomized in a 1:1 ratio to receive the FDC of formoterol 6 mcg/fluticasone 125 mcg Eurofarma (investigational drug) or Alenia® 6 mcg/200 mcg (comparator drug) (one [01] inhalation, twice a day) for 12 weeks. The primary non-inferiority assessment will be performed at the end of the 12 weeks of treatment. 2The study will be conducted in an open-label scenario, since the inhalation devices for the products have different aspects, making it impossible to blind the study treatments. The objective nature of the primary efficacy variable (forced expiratory volume in one second [FEV1]) minimizes potential bias arising from the open-label nature of the study. The duration of treatment (12 weeks) was defined based on the guidelines of the Global Initiative for Asthma (GINA 20221) and the Brazilian Society of Pulmonology and Phthisiology (SBPT) regarding the time required to assess the effectiveness of asthma maintenance treatments (three months).

Conditions

Moderate Asthma

Study Design

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

Study Groups

Formoterol 6 mcg/fluticasone 125 mcg

Formoterol 6 mcg/fluticasone 125 mcg Eurofarma.

Group Type: EXPERIMENTAL

Administration of investigation drug

Intervention Type: DRUG

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

Alenia® 6 mcg/200 mcg

Alenia® 6 mcg/200 mcg.

Group Type: ACTIVE_COMPARATOR

Administration of comparator

Intervention Type: DRUG

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

Interventions

Administration of investigation drug

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

Intervention Type: DRUG

Administration of comparator

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

Intervention Type: DRUG

Other Intervention Names

Formoterol 6 mcg/fluticasone 125 mcg; Alenia® 6 mcg/200 mcg

Eligibility 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.

• 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, , Brazil

Countries

Brazil

Other Identifiers

EF182

Identifier Type: -

Identifier Source: org_study_id