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

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.