Study of Formoterol 6 mcg/Fluticasone 125 mcg by Eurofarma Laboratórios S.A. Versus Alenia® 6 mcg/200 mcg in Patients With Asthma (FORASMA)

NCT07318350 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: EF195
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase 3, multicenter, randomized, parallel-group, open-label, non-inferiority clinical trial designed to evaluate the efficacy and safety of N0783 compared to Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) in the treatment of moderate asthma. Adult patients diagnosed with moderate asthma according to clinical and functional criteria will be enrolled. The primary objective is to demonstrate that N0783 is not inferior to Alenia® in improving asthma control. Participants will receive treatment according to the assigned intervention and will be monitored through scheduled visits for assessment of lung function, symptom control, and safety parameters throughout the study period.

Conditions

Moderate Asthma

Keywords

Asthma; Moderate Asthma; Alenia®; Non-inferiority; Randomized Clinical Trial; Phase 3

Outcome Measures

Primary Outcomes (1)

• Absolute change in pre-bronchodilator FEV₁ (L) from baseline to Week 12

  Improvement in pre-bronchodilator forced expiratory volume in one second (FEV₁), assessed by spirometry. The absolute change in FEV₁ (in liters) will be measured at Week 12 (Final Visit) compared to baseline (Randomization Visit).

  12 weeks after treatment initiation

Study Arms (2)

N0783

EXPERIMENTAL

Participants will receive N0783 administered via inhalation according to the dosing regimen specified in the protocol for the treatment of moderate asthma.

Drug: N0783

Alenia®

ACTIVE COMPARATOR

Participants will receive Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) administered via inhalation according to the dosing regimen specified in the protocol for the treatment of moderate asthma.

Drug: Alenia® (Formoterol 6 mcg / Budesonide 200 mcg)

Interventions

N0783 DRUG

N0783 is a fixed-dose combination administered via inhalation using a metered-dose inhaler. Participants will receive the study drug according to the dosing regimen specified in the protocol for the treatment of moderate asthma.

N0783

Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) DRUG

Alenia® is a fixed-dose combination of Formoterol 6 mcg and Budesonide 200 mcg administered via inhalation using a metered-dose inhaler. Participants will receive the comparator drug according to the dosing regimen specified in the protocol for the treatment of moderate asthma.

Alenia®

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 12 and ≤ 65 years at Screening.
• History of recurrent asthma symptoms (cough, wheezing, shortness of breath, chest tightness).
• Previous medical diagnosis of asthma (confirmed by records, prescriptions, or participant report).
• Documented reversible airway obstruction by spirometry: FEV₁ increase ≥ 200 mL and ≥ 12% post-bronchodilator (at screening or prior report).
• Moderate asthma (GINA step 3) for ≥ 6 months, clinically stable and controlled with LABA + low-dose inhaled corticosteroid for ≥ 90 days.
• ACQ-7 score ≤ 0.75 at Screening.
• At Randomization: ACQ-7 score ≤ 0.75 and ≥ 70% adherence during run-in.

You may not qualify if:

• Moderate/severe asthma exacerbation within 90 days prior to screening.
• Other pulmonary disease (including predominant COPD).
• Symptomatic acute or chronic respiratory infection.
• BMI ≥ 40 kg/m².
• Use of LAMA within 6 months prior to screening.
• Oral or depot corticosteroids within 30 days prior to screening.
• Biologic therapy for asthma, allergic rhinitis, or urticaria within 12 months prior to screening.
• Systemic vasoconstrictors within 7 days prior to screening.
• Known hypersensitivity to formoterol, fluticasone, budesonide, or any component of study drugs.
• Active pulmonary tuberculosis or fungal airway infection.
• History or presence of ischemic heart disease, severe arrhythmias, cardiac decompensation, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm, pheochromocytoma, hypertrophic obstructive cardiomyopathy, thyrotoxicosis, QTc \> 450 ms.
• History of hyperthyroidism or uncontrolled diabetes mellitus.
• Severe or uncontrolled disease at investigator's discretion.
• Pregnancy or breastfeeding; women of childbearing potential not using effective contraception.
• Participation in another clinical trial within 12 months unless direct benefit expected.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

MeSH Terms

Conditions

Asthma

Interventions

Formoterol Fumarate; Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Luiza Terranova

CONTACT

+551150908421; luiza.terranova@eurofarma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 6, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-12