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

January 5, 2026 updated by: Eurofarma Laboratorios S.A.

Phase 3, Multicenter, Randomized, Parallel-group, Open-label, Non-inferiority Study of N0783 Versus Comparator (Formoterol 6 mcg / Budesonide 200 mcg) in the Treatment of Moderate Asthma

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

174

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Any condition making participant unsuitable for study per investigator.
  • At Randomization: asthma exacerbation during run-in, prohibited medication use, HbA1c ≥ 10%, TSH below normal, ALT or AST > 2× ULN, serum potassium below normal, severe renal impairment (eGFR < 30 mL/min/1.73m²), clinically significant ECG changes or QTc > 450 ms, or any abnormality making participant unsuitable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N0783
Participants will receive N0783 administered via inhalation according to the dosing regimen specified in the protocol for the treatment of moderate asthma.
Drug: N0783
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.
Active Comparator: Alenia®
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change in pre-bronchodilator FEV₁ (L) from baseline to Week 12
Time Frame: 12 weeks after treatment initiation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurofarma Laboratorios S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Estimated)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF195

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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