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.
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/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.
Parallel
N0783
DrugN0783 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.
Alenia® (Formoterol 6 mcg / Budesonide 200 mcg)
DrugAlenia® 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.
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).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
