To evaluate the efficacy and safety of SHR-4597 inhalants in adults with asthma: a multicenter, randomized, open-label, positive-controlled Phase II clinical study
Age ≥18 years old and ≤75 years old, gender is not limited;
Body mass index (BMI) ≥18 and ≤30 kg/m2 during screening period;
Medical history and objective evidence consistent with current guidelines supporting an asthma diagnosis within the 12 months prior to randomization;
Did not receive inhaled corticosteroids (ICS) and/or combined with other asthma control medications within 2 weeks prior to randomization;
Combined diseases or conditions
Clinically significant pulmonary diseases, including but not limited to active pulmonary tuberculosis, bronchiectasis, atelectasis, idiopathic pulmonary fibrosis, bronchopulmonary aspergillosis, and chronic obstructive pulmonary disease (COPD);
Malignant tumors diagnosed within 5 years prior to randomization (except those with a low risk of metastasis and death, such as well-treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
Combined with poorly controlled hypertension (systolic blood pressure ≥180mmHg, and/or diastolic blood pressure ≥110mmHg during the screening period) or uncontrolled severe cardiovascular and cerebrovascular diseases; ④ Known immunodeficiency;
Parallel
SHR4597
DrugSHR4597
Budesonide inhalant
DrugBudesonide inhalant
Changes in FEV1 (Pre-BD) from baseline
Changes in FEV1 before bronchodilator (Pre-BD) administration compared with baseline at week 42
Changes in forced vital capacity (FVC) before bronchodilator (Pre-BD) use compared with baseline at week 42
Changes in peak expiratory flow (PEF) before bronchodilator (Pre-BD) use compared with baseline at week 42
Changes in exhaled nitric oxide (FeNO) from baseline at 42 weeks
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