Beclometasone Dipropionate and Formoterol Inhalation Aerosol for Asthma

A multicenter, randomized, double-blind, active-controlled, parallel-group Phase III clinical study comparing the efficacy and safety of Beclometasone Dipropionate and Formoterol Inhalation Aerosol versus FOSTER® in patients with asthma. The purpose of this study is to compare the efficacy and safety of the Beclomethasone Dipropionate and Formoterol Fumarate inhalation aerosol (manufactured by Lunan Better Pharmaceutical Co., Ltd.) with FOSTER® in the treatment of patients with asthma.

Inclusion Criteria: 1. Male or female aged ≥18 and ≤75 years. 2. Clinically diagnosed with bronchial asthma for at least 3 months at screening (with traceable diagnostic evidence and medical records), and the diagnosis has been confirmed according to the Guidelines for the Prevention and Management of Bronchial Asthma, meeting the following criteria: a) Positive objective test for variable airflow limitation (i.e., meeting any one of the following): (i) Positive bronchodilator reversibility test (i.e., an increase in FEV₁ of ≥12% and an absolute increase of ≥200 mL from pre-bronchodilator values after inhalation of a bronchodilator; or an increase in FEV₁ of ≥12% and an absolute increase of ≥200 mL from baseline after 4 weeks of anti-inflammatory therapy with an inhaled corticosteroid, excluding respiratory tract infections); or (ii) Positive bronchial provocation test: commonly using methacholine or histamine as the inhaled provocative agent, with a positive result defined as a ≥20% decrease in FEV₁ after inhalation, indicating airway hyperresponsiveness. (A positive result from any confirmed objective test for variable airflow limitation performed within 1 year prior to signing the ICF is acceptable; if not available, a positive bronchial provocation or bronchodilator reversibility test must be met at screening.) b) Pulmonary function test: FEV₁ ≥40% of predicted value. 3. Within at least 4 weeks prior to signing the ICF, the subject has been on a stable daily dose of an inhaled corticosteroid (ICS) with "as-needed" short-acting β₂-agonist (SABA) use but asthma is not well controlled (ACQ-5 ≥1.00), OR has been on a stable daily dose of an ICS plus a long-acting β₂-agonist (LABA) and asthma is well controlled (ACQ-5 \2×ULN and/or aspartate aminotransferase (AST) \>2×ULN, and total bilirubin (TBIL) \>2×ULN; Renal function: serum creatinine \>1.5×ULN; Fasting blood glucose \>10 mmol/L or glycated hemoglobin (HbA1c) ≥8.0%; Serum potassium \