Core Viewpoint - The article discusses the recruitment of participants for a Phase III clinical trial evaluating the efficacy and safety of CM326, a recombinant humanized monoclonal antibody injection, in moderate to severe asthma patients [1][3]. Group 1: Background Information - The clinical trial is approved by the National Medical Products Administration (Approval No: 2021LP00315) and has been reviewed by the hospital clinical trial ethics committee [1][3]. - Participants will receive the study drug, examination costs, and a certain amount of compensation for their participation [1][3]. Group 2: Inclusion Criteria - Participants must be aged between 18 and 80 years and weigh at least 40 kg [4]. - Lung function tests must show that the forced expiratory volume in one second (FEV1) is ≤80% of the predicted value [4]. - Participants must have a positive bronchodilator test within 24 months prior to signing informed consent [5]. - They should have been on a stable treatment regimen of medium to high doses of inhaled corticosteroids combined with at least one control medication for at least 3 months prior to screening [5]. - Participants must have experienced at least one severe asthma exacerbation in the 12 months prior to signing informed consent, but none in the 30 days before signing [5]. Group 3: Research Centers - The trial will be conducted across multiple hospitals, including Shanghai Jiao Tong University Affiliated Ruijin Hospital, Shanghai Tongji Hospital, and Jilin University First Hospital, among others [2][6]. - A total of 44 research centers are listed, indicating a broad geographical reach for participant recruitment [6][7].
石药集团一项III期临床研究招募晚中重度哮喘患者