Budesonide/Formoterol Inhalation Powder in Adults With Asthma

Prior treatment

• Life-threatening asthma, defined as asthma attack requiring intubation within 1 year prior to screening or during run-in, and/or history of hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncope.
• Hospitalization due to asthma within 2 months prior to screening.
• Acute upper or lower respiratory tract bacterial infection requiring systemic antibiotic treatment within 4 weeks prior to screening, which led to a change in asthma treatment or, in the investigator's judgment, would alter the subject's asthma status or affect participation.
• Concurrent respiratory diseases other than asthma, including but not limited to active pneumonia, idiopathic pulmonary fibrosis, clinically significant atelectasis, active pulmonary tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, etc., which in the investigator's judgment may place the subject at undue risk or affect the assessment of study results.
• History of drug abuse, substance abuse, or alcoholism within 1 year prior to screening. Alcoholism defined as average daily alcohol consumption exceeding 2 units (1 unit = 360 mL beer, or 45 mL 40% liquor, or 150 mL wine).
• Current treatment with beta-blockers (including eye drops).
• Systemic corticosteroid use: within 4 weeks prior to screening or during screening/run-in requiring systemic corticosteroid therapy, or asthma requiring oral corticosteroid treatment.
• Use of biologic targeted therapies including anti-IgE monoclonal antibodies (e.g., omalizumab), anti-IL-5 monoclonal antibodies (e.g., mepolizumab), anti-IL-5 receptor monoclonal antibodies (e.g., benralizumab), or anti-IL-4 receptor monoclonal antibodies (e.g., dupilumab), currently within 5 half-lives of the drug.
• Participation in another clinical trial and receipt of investigational drug within 2 months prior to enrollment.
• Concurrent severe underlying diseases that may affect the evaluation of study efficacy or safety, or any condition that, in the investigator's judgment, makes the subject unsuitable for enrollment.

Other illness

• Known hypersensitivity to any sympathomimetic drug (e.g., formoterol or salbutamol), any corticosteroid therapy, or lactose (excipient of the study drug).
• History of malignancy of any organ system within the past 5 years (except localized basal cell carcinoma of the skin or carcinoma in situ of the cervix), treated or untreated, with or without evidence of local recurrence or metastasis.
• History of or current treatment for glaucoma or cataracts.

Lab values

• Concurrent severe cardiovascular disease, including but not limited to:
  • NYHA Class III-IV cardiac function;
  • Severe arrhythmia, e.g., QTc ≥ 480 ms;
  • Myocardial infarction or unstable angina within 6 months prior to screening;
  • Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at rest on 2 or more consecutive measurements).
• Abnormal liver or kidney function, defined as:
  • ALT \> 2 × ULN or AST \> 2 × ULN;
  • SCr \> 1.5 × ULN.
• History of or concurrent hypokalemia, or serum potassium below the lower limit of normal at screening.
• Poorly controlled diabetes mellitus (fasting blood glucose \> 10 mmol/L or HbA1c ≥ 8.0%).

Other

• Oral examination revealing suspected candidiasis (unless definitively excluded by the investigator).
• Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test.

• Patients who can understand and comply with the study procedures and methods, are willing to strictly follow the protocol to complete the study, and have signed the written informed consent form.
• Aged 18 to 75 years (inclusive), male or female.
• Diagnosed with bronchial asthma according to the Chinese Guidelines for the Prevention and Management of Bronchial Asthma (2020 edition), with documented medical records, and currently inadequately controlled asthma (ACQ-5 score ≥ 1.0).
• Non-smokers, or have quit smoking for at least 1 year (including cigarettes, cigars, pipe tobacco), with a smoking history of ≤ 30 pack-years \[smoking index (pack-years) = daily smoking amount (packs) × smoking duration (years), 1 pack = 20 cigarettes\].
• Positive result from any objective test for variable airflow limitation, either:
  • Positive evidence from tests performed within 1 year prior to screening, including bronchodilator reversibility test, bronchial provocation test, or mean daily PEF diurnal variability \> 10% or weekly PEF variability \> 20%; or
  • If no positive test result within 1 year prior to screening, positive bronchodilator reversibility test during screening (FEV1 increase \> 12% and absolute increase \> 200 mL, 15-30 minutes after inhalation of 400 μg salbutamol), or positive bronchial provocation test.
• Pre-bronchodilator FEV1 between 45% and 85% of predicted normal value at screening.
• Patients who agree to have no plans for fertility, sperm or egg donation, and voluntarily use effective physical contraception (including their partners) during the study and for 3 months after the last dose.