Clinical Study on the Efficacy and Safety of SHR-4597 Inhalant in Adult Patients With Asthma

ConditionAsthma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • SHR4597
  • Budesonide inhalant

Treatment groups

60 Participants
are divided into 3 treatment groups