PA9159 is a highly potent novel corticosteroid. The purpose of this study is to evaluate the safety, efficacy and characteristics of population pharmacokinetics of multiple dosing of PA9159 Inhalation Aerosol in patients with bronchial asthma.
Aged 18 to 75 years inclusive, regardless of gender;
According to the definition in the Chinese "Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)," subjects diagnosed with bronchial asthma, including those with an initial diagnosis of asthma, or those diagnosed with asthma during childhood or adolescence with stable condition who have not received long-term treatment but exhibit significantly more pronounced symptoms in adulthood and/or recently compared to the past;
Pre-randomization, pulmonary function tests show 60% ≤ FEV1% predicted ≤ 85%;
Any objective test result indicating variable airflow limitation conducted within 1 year prior to screening is positive, or the bronchodilator test during the screening period is positive, i.e., an increase in FEV1 ≥ 12% and an absolute increase in FEV1 ≥ 200 mL 15-30 minutes after inhaling 400 μg salbutamol (if the bronchodilator test result does not meet the positive threshold, a repeat bronchodilator test is allowed within 14 days after the test [excluding the test day]); or the bronchial provocation test is positive, i.e., a decrease in FEV1 ≥ 20% after inhaling a provocant (methacholine or histamine); or the average daily diurnal variability of peak expiratory flow (PEF) (calculated as the sum of daily PEF diurnal variability over 7 consecutive days divided by 7) > 10%;
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;
Parallel
PA9159 Metered-Dose Inhaler, 60 μg per day for 28 days
DrugPA9159 of 60 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.
PA9159 Metered-Dose Inhaler, 120 μg per day for 28 days
DrugPA9159 of 120 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.
PA9159 Metered-Dose Inhaler, 240 μg per day for 28 days
DrugPA9159 of 240 μg is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.
Placebo Metered-Dose Inhaler without PA9159, Twice daily for 28 days
DrugPlacebo is delivered orally through a metered-dose Inhaler , Twice daily for 28 days.
Evaluation the change in morning pre-dose forced expiratory volume in one second (FEV1) from baseline to week 4 of treatment.
After the subject takes a deep breath as much as possible, the volume of air that can be exhaled in the first second when exhaling with maximum force and speed. This is one of the most core indicators in pulmonary function tests, directly reflecting the patency of the airways (especially the large airways). A lower FEV₁ value indicates more severe airway obstruction. Therefore, the difference is calculated as the value after 28 days of treatment minus the baseline value. A larger upward change indicates more significant symptom improvement.
Evaluation the change from baseline in pre-dose FEV1 at week 1 and week 2 of treatment.
Evaluation the change from baseline in pre-dose morning and evening peak expiratory flow (PEF) at weeks 1, 2, and 4 of treatment.
Proportion of patients with asthma exacerbations during the treatment period.
Proportion and frequency of patients using rescue medication over the 4-week treatment period.
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