Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma

Exclusion Criteria

• •Subjects who are unable to correctly use a nebulizer, cannot tolerate nebulized inhalation administration, or fail inhalation administration training;
• •Subjects with other pulmonary diseases, including chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, tuberculosis, etc., for which, in the investigator's judgment, asthma remains the dominant condition;
• •Coexistence of other clinically significant conditions that may affect lung function, including but not limited to pleural diseases, mediastinal diseases, diaphragmatic disorders, myasthenia, thoracic deformities, etc.;
• •History of severe cardiovascular diseases, such as congestive heart failure, coronary artery disease, myocardial infarction, arrhythmia, uncontrolled hypertension (resting seated systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on two or more consecutive measurements), etc., which, in the investigator's judgment, would put the subject at risk or may affect the interpretation of study results;
• •Subjects with hyperthyroidism, assessed by the investigator as unsuitable for participation in this trial;
• •History of severe hematologic, hepatic, psychiatric, renal, or other diseases that, in the investigator's judgment, would put the subject at risk or may affect the interpretation of study results;
• •History of malignancy within the past five years (excluding cured cervical intraepithelial neoplasia, thyroid cancer, or basal cell carcinoma of the skin diagnosed and cured within 5 years);
• •Subjects who have undergone or are expected to undergo solid organ or bone marrow transplantation within the next year;
• •Hypokalemia (serum potassium \< 3.5 mmol/L during screening);
• •Type I diabetes or poorly controlled Type II diabetes (fasting blood glucose \> 11.1 mmol/L during screening);
• •Known or pre-randomization examination revealing oral, pharyngeal, or esophageal candidiasis;
• •Abnormal liver or kidney function during screening (ALT and/or AST \> 2× upper limit of normal; Scr \> 1.5× upper limit of normal);
• •Positive hepatitis B surface antigen or hepatitis B core antibody with HBV DNA ≥ 2000 IU/mL, positive hepatitis C antibody with HCV RNA ≥ 1000 IU/mL, positive human immunodeficiency virus antibody, or history of acquired immunodeficiency syndrome;
• •Known allergy to any component of inhaled corticosteroids or salbutamol preparations;
• •Respiratory tract infection, sinus infection, or acute otitis media within 4 weeks before screening or during the run-in period, which, in the investigator's judgment, would lead to changes in asthma treatment or affect the subject's asthma status;
• •Asthma exacerbation requiring systemic corticosteroid treatment within 4 weeks before screening or during the run-in period, or asthma requiring oral corticosteroid therapy, or other conditions requiring systemic corticosteroid treatment;
• •Use of strong CYP3A4 enzyme inhibitors (e.g., ritonavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, etc.) within 4 weeks before dosing, or need for concomitant use of strong CYP3A4 inhibitors during the trial;
• •Smoking cessation \< 1 year at screening (including cigarettes, cigars, pipe tobacco, e-cigarettes, etc.), or previous smoking history \> 10 pack-years \[pack-years = number of packs per day × years of smoking, where 1 pack = 20 cigarettes\];
• •History of drug abuse, substance abuse, or alcoholism within 2 years before screening \[alcoholism defined as average daily alcohol intake \> 2 units (1 unit = 360 mL beer, or 45 mL of 40% alcohol liquor, or 150 mL wine)\];
• •Pregnant or lactating women, or women planning pregnancy during the trial;
• •Subjects who have participated in other clinical trials within 1 month before screening;
• •Any other reason considered by the investigator to make the subject unsuitable for participation in the trial.