中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600121738
最近更新日期： Date of Last Refreshed on：	2026-04-02 10:11:41
注册时间： Date of Registration：	2026-04-02 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	阿得贝利单抗联合化疗一线治疗晚期NSCLC合并慢性阻塞性肺疾病患者的前瞻性、探索性临床研究
Public title：	A Phase II Prospective Clinical Study of Adebrelimab combined with Chemotherapy as First-Line Treatment for Advanced Non-Small Cell Lung Cancer Complicated with Chronic Obstructive Pulmonary Disease
注册题目简写：
English Acronym：
研究课题的正式科学名称：	阿得贝利单抗联合化疗一线治疗晚期NSCLC合并慢性阻塞性肺疾病患者的前瞻性、探索性临床研究
Scientific title：	A Phase II Prospective Clinical Study of Adebrelimab combined with Chemotherapy as First-Line Treatment for Advanced Non-Small Cell Lung Cancer Complicated with Chronic Obstructive Pulmonary Disease
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	吕镗烽	研究负责人：	吕镗烽
Applicant：	Tangfeng Lv	Study leader：	Tangfeng Lv
申请注册联系人电话： Applicant telephone：	+86 138 1452 0736	研究负责人电话： Study leader's telephone：	+86 138 1452 0736
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	lvtangfeng1972@163.com	研究负责人电子邮件： Study leader's E-mail：	lvtangfeng1972@163.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	江苏省南京市中山东路305号	研究负责人通讯地址：	江苏省南京市中山东路305号
Applicant address：	305 Zhongshan East Road, Nanjing, Jiangsu Province	Study leader's address：	305 Zhongshan East Road, Nanjing, Jiangsu Province
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	南京大学医学院附属金陵医院呼吸与危重症医学科
Applicant's institution：	Department of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
研究负责人所在单位：	南京大学医学院附属金陵医院呼吸与危重症医学科
Affiliation of the Leader：	Department of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2026DZKY-006-01	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	南京大学医学院附属金陵医院临床研究伦理委员会
Name of the ethic committee：	Ethics Committee for Clinical Research, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
伦理委员会批准日期： Date of approved by ethic committee：	2026-01-27 00:00:00
伦理委员会联系人：	吴琼
Contact Name of the ethic committee：	Wu Qiong
伦理委员会联系地址：	江苏省南京中山东路305号
Contact Address of the ethic committee：	305 Zhongshan East Road, Nanjing, Jiangsu Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 25 8086 3234	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

南京大学医学院附属金陵医院

Primary sponsor：

inling Hospital, Affiliated Hospital of Medical School, Nanjing University

研究实施负责（组长）单位地址：

江苏省南京中山东路305号

Primary sponsor's address：

305 Zhongshan East Road, Nanjing, Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	南京大学医学院附属金陵医院	具体地址：	江苏省南京中山东路305号
Institution hospital：	Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University	Address：	305 Zhongshan East Road, Nanjing, Jiangsu Province

经费或物资来源：

南京大学

Source(s) of funding：

Nanjing University

研究疾病：

晚期非小细胞肺癌

Target disease：

Advanced Non-Small Cell Lung Cancer

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

非随机对照试验

Study design：

Non randomized control

研究目的：

主要目的：评价阿得贝利单抗单药或联合化疗（化疗方案建议：鳞癌：顺铂/卡铂+白蛋白紫杉醇，非鳞癌：顺铂/卡铂+培美曲塞）疗治晚期一线NSCLC合并慢阻肺患者的无进展生存期（PFS）。次要目的：评价阿得贝利单抗单药或联合化疗（化疗方案建议：鳞癌：顺铂/卡铂+白蛋白紫杉醇，非鳞癌：顺铂/卡铂+培美曲塞）疗治晚期一线NSCLC合并慢阻肺患者的总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DoR）、安全性、生活质量改善情况、COPD 急性加重率（次/年）。探索性目的：吸入性ICS药物的使用对阿得贝利单抗单药或联合化疗治疗NSCLC合并慢阻肺患者疗效的影响。

Objectives of Study：

Primary Objective :To evaluate the progression-free survival (PFS) with adebrelimab monotherapy or combined with chemotherapy as first-line treatment in advanced NSCLC patients with COPD Secondary Objective :To evaluate the overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR), safety, improvement in quality of life, and rate of acute exacerbation of COPD (episodes per year) in patients with previously untreated advanced non-small cell lung cancer (NSCLC) complicated with chronic obstructive pulmonary disease (COPD) receiving Adebrelimab monotherapy or in combination with chemotherapy. Exploratory Objective: To explore the effect of inhaled corticosteroid (ICS) administration on the clinical efficacy of Adebrelimab administered as monotherapy or in combination with chemotherapy for the treatment of patients with advanced NSCLC and concurrent COPD.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

患者必须满足以下所有入组标准，才可入组本研究：
1. 自愿加入本研究并签署知情同意书（Inform consent form，ICF）；愿意并有能力遵从计划的访视、研究治疗、实验室检查及其他试验程序；
2. ECOG评分0~2分；
3. 年龄18-75 岁，男女不限；
4. 通过组织病理学或细胞病理学诊断证明为转移或复发性Ⅳ期NSCLC（AJCC 第八版TNM分期）；
5. 肿瘤组织学或细胞学证实无EGFR敏感突变、ALK融合阳性或ROS1融合阳性突变
6. 既往未接受过针对晚期/转移性疾病的任何系统性抗肿瘤治疗（对于既往曾接受过辅助化疗、新辅助化疗或放化疗的患者，如果诊断出晚期或转移性疾病的时间距最后一次治疗结束>12 个月，则有资格参加本研究）
7. 符合中华医学会呼吸分会制定的《慢性阻塞性肺疾病诊治指南(2021年修订版)》及《慢性阻塞性肺疾病（COPD）全球诊断、管理与预防策略（2025 年报告）》中 COPD 相关诊断标准，且病情稳定≥2周的COPD患者（稳定期患者）；
8. 影像学评估（CT或MRI），至少有一个可测量的靶病灶（RECIST v1.1）；
9. 无症状或经过治疗的稳定的脑转移患者可纳入，符合研究方案的实验室指标；
10. 育龄期女性受试者必须在首次用药前7天内进行血清妊娠试验，且结果为阴性，并且愿意在研究期间和末次给予研究药物后3个月内采用一种经医学认可的高效避孕措施（如：宫内节育器、避孕药或避孕套）；对于伴侣为育龄期女性的男性受试者，需手术绝育，或同意在研究期间和末次研究给药后3个月内采用有效的方法避孕。
11. 重要器官的功能符合下列要求：
（1）血常规：白细胞计数（WBC）≥3.0×109/L；绝对中性粒细胞计数（ANC）≥1.5×109/L；血小板（PLT）≥100×109/L；血红蛋白含量（HGB）≥9.0 g/dL（7日内无相应的输血、升白细胞等支持治疗）；
（2）肝功能：无肝转移患者天门冬氨酸氨基转移酶（AST）、丙氨酸氨基转移酶（ALT）≤2.5倍ULN，肝转移患者其ALT和AST≤5倍ULN；血清总胆红素（TBIL）≤1.5倍ULN (除外Gilbert 综合征总胆红素＜3.0 mg/dL)；白蛋白（ALB）≥30g/L，碱性磷酸酶（ALP）≤2.5×ULN，骨转移患者，ALP≤5×ULN；
（3）肾功能：血清肌酐≤1.5倍ULN 或肌酐清除率 (CrCl) ≥50 mL/min (使用 Cockcroft/Gault 公式) ；尿蛋白（UPRO）＜(++)，或 24 小时尿蛋白量＜1.0 g；
（4）凝血功能：国际标准化比率（INR）≤1.5且活化部分凝血活酶时间（APTT）≤1.5倍ULN；若患者正在接受抗凝治疗，则只要PT或APTT在预期使用抗凝剂的治疗范围内，具体参考相关药物说明书；
（5）促甲状腺激素(TSH)≤正常值上限(ULN)，如果异常应考察T3和T4水平，T3和T4水平正常则可以入选。

Inclusion criteria

Patients must meet all the following inclusion criteria to be enrolled in this study:
1. Patients who voluntarily participate in the study, sign and date the informed consent form, have good compliance, and cooperate with the follow-up;
2. ECOG score of 0-1;
3. 18 years old <= age <= 75 years old, male or female;
4. Histopathologically confirmed NSCLC and radically metastatic or recurrent stage IV (as judged by the IASLC Staging Manual in Thoracic Oncology, 8th Edition);
5. The study site should obtain tumor tissue for epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion positivity, or c-ros oncogene 1 (ROS1) fusion mutation test, and no sensitive mutations are found in the these test results.
6. No prior systemic antineoplastic treatment for advanced/metastatic disease (patients who have previously received adjuvant chemotherapy, neoadjuvant chemotherapy, or chemoradiotherapy are eligible to participate in this study if the time from the end of the last treatment to the diagnosis of advanced or metastatic disease is > 12 months).
7. Patients with chronic obstructive pulmonary disease (COPD) who meet the COPD-related diagnostic criteria specified in the Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (Revised Edition 2021) formulated by the Respiratory Branch of the Chinese Medical Association and the Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2025 Report) (GOLD 2025), with stable condition for >= 2 weeks (stable phase patients).
8. Imaging evaluation (computed tomography [CT] or magnetic resonance imaging [MRI]) shows at least one measurable target lesion (according to Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1).
9. Asymptomatic or treated stable brain metastasis patients can be included, with laboratory indicators meeting the study protocol requirements.
10. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours before the first dose. Women of childbearing potential and male subjects with a female partner of childbearing potential must agree to use highly effective methods of contraception and avoid breastfeeding during the study and for 90 days after the last dose of study drug. After consultation with the subject, the investigator or his/her designee should confirm that the subject knows how to correctly and continuously use contraceptive methods.
11. Function of important organs meets the following requirements:
    (1) Blood routine: White blood cell (WBC) count >= 3.0 × 10^9/L; absolute neutrophil count (ANC) >= 1.5 × 10^9/L; platelet (PLT) count >= 100 × 10^9/L; hemoglobin (HGB) >= 9.0 g/dL (without corresponding supportive treatments such as blood transfusion or leukocyte elevation within 7 days).
    (2) Liver function: For patients without liver metastasis, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 × upper limit of normal (ULN); for patients with liver metastasis, ALT and AST <= 5 × ULN; serum total bilirubin (TBIL) <= 1.5 × ULN (except for Gilbert syndrome with total bilirubin < 3.0 mg/dL); albumin (ALB) >= 30 g/L; alkaline phosphatase (ALP) <= 2.5 × ULN; for patients with bone metastasis, ALP <= 5 × ULN.
    (3) Renal function: Serum creatinine <= 1.5 × ULN or creatinine clearance rate (CrCl) >= 50 mL/min (calculated by the Cockcroft/Gault formula); urinary protein (UPRO) < (++), or 24-hour urinary protein quantification < 1.0 g.
    (4) Coagulation function: International normalized ratio (INR) <= 1.5 and activated partial thromboplastin time (APTT) <= 1.5 × ULN; if the patient is receiving anticoagulant therapy, it is acceptable as long as prothrombin time (PT) or APTT is within the expected therapeutic range of the anticoagulant used, with specific reference to the relevant drug instructions.
    (5) Thyroid function: Thyroid-stimulating hormone (TSH) <= ULN; if abnormal, triiodothyronine (T3) and tetraiodothyronine (T4) levels should be evaluated, and patients with normal T3 and T4 levels are eligible for inclusion.

排除标准：

1. 既往接受过放疗、化疗或分子靶向治疗； 2. 有临床症状的中枢神经系统转移（如脑、脊髓）、软脑膜转移的受试者； 3. 在首剂研究药物前接受了针对胸部和全脑的放疗（骨病灶的姑息性放疗在首剂研究药物前完成允许入组）； 4. 哮喘或其他呼吸系统疾病史（支气管扩张、肺结核、间质性肺炎、职业性肺病、结节病等）有放射性肺炎、药物相关肺炎或肺功能严重受损的客观证据的患者； 5. 肺量测定的显著禁忌症（心肌梗死、脑动脉或主动脉瘤史、眼部手术史、咯血） 6. 首次给药前2年内发生过需要全身性治疗（例如使用缓解疾病药物、皮质类固醇或免疫抑制剂）的活动性自身性免疫疾病或有自身免疫病病史且预期复发。替代疗法（例如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性皮质类固醇等）不视为全身性治疗； 7. 诊断为免疫缺陷或研究首次给药前14天内正在接受全身性糖皮质激素治疗或任何其他形式的免疫抑制疗法；允许使用生理剂量的糖皮质激素（≤10 mg/天的强的松或等效药物）； 8. 首次给药前6个月内发生过动/静脉血栓事件，如脑血管意外（包括暂时性缺血性发作、脑出血、脑栓塞等）、深静脉血栓及肺栓塞者； 9. 首次给药前3个月内，出现过有临床意义的出血症状或具有明确出血倾向证据或病史的受试者，如消化道出血、出血性胃溃疡、基线期大便潜血++及以上，或患有脉管炎等，无论严重程度如何； 10. 首次给药前 28 天内接受了重大外科治疗或明显创伤性损伤； 11. 首次给药前4周内接种过或计划接种预防疫苗或减毒活疫苗； 12. 签署ICF前4周内曾接受其它任何试验药物治疗或参加过另一项干预性临床研究； 13. 5年内受试者既往或同时患有其它恶性肿瘤需要积极治疗(已充分治疗的如预计5年生存期>90%基底细胞或鳞状上皮细胞皮肤癌、宫颈原位癌、根治术后的局部前列腺癌、局限性膀胱癌、根治术后的导管原位癌、原位乳腺癌除外)； 14. 心、脑血管、肝、肾、造血系统等严重原发性疾病患者。 15. 既往严重过敏史，已知对阿得贝利单抗、卡铂、顺铂、培美曲塞的活性成分和/或任何辅料有过敏反应，给药期间过敏或不能耐受；对其他任何单克隆抗体过敏； 16. 受试者有其他可能导致本研究被迫中途终止的因素，如，不依从方案、其他的严重疾病（含精神疾病）需要合并治疗、酗酒、无法戒烟、药物或物质滥用的受试者，有严重的实验室检查异常，伴有家庭或社会等因素，会影响到受试者的安全，或资料及样品的收集，及研究者认为患者不适合参加本研究的其他任何情况。

Exclusion criteria：

1. Patients who have received any prior anti-tumor therapy, including radiotherapy, chemotherapy, immunotherapy and traditional Chinese medicine for anti-tumor therapy; 2. Patients with clinically symptomatic central nervous system metastases (e.g., brain, spinal cord) or leptomeningeal metastases; 3. Patients who received radiotherapy to the chest and whole brain prior to the first dose of study treatment (palliative radiotherapy for bone lesions completed before the first dose of study drug is permitted for enrollment); 4. Patients with a history of asthma or other respiratory diseases (bronchiectasis, pulmonary tuberculosis, interstitial pneumonia, occupational lung disease, sarcoidosis, etc.) and with objective evidence of radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function; 5. Significant contraindications to spirometry (history of myocardial infarction, cerebral or aortic aneurysm, ocular surgery, hemoptysis); 6. Patients with any active autoimmune diseases or history of autoimmune diseases (e.g., uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (patients may be included after hormone replacement therapy), pulmonary tuberculosis); patients with childhood asthma that has been in complete response (CR) and does not require any intervention after adulthood may be included, patients with skin diseases that do not require systemic therapies (e.g., vitiligo, psoriasis, or alopecia) may be included, and patients who require medical intervention with bronchodilators may not be included; 7. Diagnosis of immunodeficiency, or ongoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment. Use of physiological doses of glucocorticoids (<=10 mg/day prednisone or equivalent) is permitted; 8. Arterial or venous thrombotic events within 6 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, and pulmonary embolism; 9. Clinically significant bleeding symptoms, or clear evidence or history of bleeding tendency within 3 months prior to the first dose, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood >=++ at baseline, or vasculitis, regardless of severity; 10. Major surgical treatment or significant traumatic injury within 28 days prior to the first dose; 11. Subjects who have received treatment with anti-tumor vaccines or other anti-tumor drugs with immunostimulatory effects (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month prior to the first dose; 12. Received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the informed consent form (ICF); 13. Subjects with a prior or concurrent malignancy requiring active treatment within 5 years (excluding adequately treated malignancies with an expected 5-year survival rate >90%, such as basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, localized prostate cancer after radical surgery, localized bladder cancer, ductal carcinoma in situ after radical surgery, and breast carcinoma in situ); 14. Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, hematopoietic systems, or other severe organ dysfunctions; 15. History of severe hypersensitivity, known hypersensitivity to the active ingredients and/or any excipients of adebrelimab, carboplatin, cisplatin, or pemetrexed, hypersensitivity or intolerance during administration; hypersensitivity to any other monoclonal antibodies; 16. Subjects with other factors that may lead to premature discontinuation from the study, such as non-compliance with the protocol, other severe diseases (including psychiatric disorders) requiring concomitant treatment, alcohol abuse, inability to quit smoking, drug or substance abuse, severe abnormal laboratory findings, or family/social factors that may compromise subject safety, data or sample collection. Any other conditions in which the investigator deems the patient unsuitable for study participation will also be excluded.

研究实施时间：

Study execute time：

从 From 2026-03-12 00:00:00至 To 2031-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-03 00:00:00 至 To 2027-09-30 00:00:00

干预措施：

Interventions：

组别：	实验组	样本量：	30
Group：	Experimental group	Sample size：	30
干预措施：	单药治疗组：COPD患者根据GLOD分级为3级且符合入组标准患者接受阿得贝利单抗20 mg/kg，静脉输注，Q3W，使用至PD、不可耐受的毒性、患者撤回知情同意、研究者决定终止研究治疗。	干预措施代码：
Intervention：	Monotherapy Group: COPD patients with GOLD grade 3 who meet the inclusion criteria will receive adebrelimab 20 mg/kg by intravenous infusion every 3 weeks (Q3W), continued until disease progression (PD), intolerable toxicity, patient withdrawal of informed consent, or investigator decision to terminate study treatment.	Intervention code：

组别：	实验组	样本量：	30
Group：	Experimental group	Sample size：	30
干预措施：	联合治疗组：COPD患者根据GLOD分级为1-2级且符合入组标准的患者，非鳞癌患者：接受阿得贝利单抗 20mg/kg，静脉输注，Q3W，联合化疗（化疗方案建议：培美曲塞500mg/m2，静脉滴注，Q3W±卡铂AUC 5.0/顺铂，静脉滴注，Q3W）；鳞癌患者接受阿得贝利单抗 20mg/kg，Q3W，联合卡铂AUC 5.0/顺铂+白蛋白紫杉醇100mg/m2, D1、8、15或260mg/m2, D1，静脉输注，Q3W。化疗治疗4-6个周期，阿得贝利单抗、维持使用至PD、不可耐受的毒性、患者撤回知情同意、研究者决定终止研究治疗。	干预措施代码：
Intervention：	Combination Therapy Group: COPD patients with GOLD grade 1-2 who meet the inclusion criteria will receive treatment as follows: - Non-squamous cell carcinoma patients: adebrelimab 20 mg/kg by intravenous infusion Q3W combined with chemotherapy (suggested chemotherapy regimen: pemetrexed 500 mg/m2 by intravenous drip Q3W ± carboplatin AUC 5.0/cisplatin by intravenous drip Q3W); - Squamous cell carcinoma patients: adebrelimab 20 mg/kg Q3W combined with carboplatin AUC 5.0/cisplatin plus albumin-bound paclitaxel (100 mg/m2 on Day 1, 8, 15 or 260 mg/m2 on Day 1) by intravenous infusion Q3W. Chemotherapy will be administered for 4-6 cycles, and adebrelimab will be maintained until PD, intolerable toxicity, patient withdrawal of informed consent, or investigator decision to terminate study treatment.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	江苏省苏北人民医院	单位级别：	三甲
Institution hospital：	Northern Jiangsu People's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	江苏省	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	南通大学附属医院	单位级别：	三甲
Institution hospital：	The Affiliated Hospital of Nantong University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	无进展生存	指标类型：	主要指标
Outcome：	Progression-free survival,(PFS)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	Overall survival, OS	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	客观缓解率	指标类型：	次要指标
Outcome：	Objective response rate, ORR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疾病控制率	指标类型：	次要指标
Outcome：	Disease control rate, DCR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	缓解持续时间	指标类型：	次要指标
Outcome：	Disease Control Rate,DCR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全性数据	指标类型：	次要指标
Outcome：	Adverse Event,AE	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	COPD 急性加重率（次/年）	指标类型：	次要指标
Outcome：	Rate of acute exacerbations of COPD (per patient-year)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	None	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age		岁 years
最大 Max age		岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：
Blinding：

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	lvtangfeng1972@163.com
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	lvtangfeng1972@163.com
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	病历记录和电子采集管理
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF and an electronic data capture
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-04-02 10:11:36