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
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Enrollment
- 174
- Primary Endpoint
- Absolute change in pre-bronchodilator FEV₁ (L) from baseline to Week 12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Alenia® (Formoterol 6 mcg / Budesonide 200 mcg) (Drug)
N0783
Participants will receive N0783 administered via inhalation according to the dosing regimen specified in the protocol for the treatment of moderate asthma.
Intervention: N0783 (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported