NCT07583589尚未招募2 期
A Multicenter, Randomized, Double Blind, Placebo-controlled Clinical Study to Evaluate the Treatment of Nidanib With or Without Dextromethorphan in Idiopathic Pulmonary Fibrosis (IPF) Patients.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
Nintedanib combined with or without Dextromethorphan for the treatment of IPF, with FVC as the primary efficacy endpoint to evaluate its effectivenes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥40 years old, regardless of gender;
- •According to "2022 ATS/ERS/JRS/ALAT Guidelines", it was diagnosed as idiopathic pulmonary fibrosis (IPF);
- •Lung function meets the following conditions during screening: forced vital capacity (FVC) ≥45% predicted value; The dispersion of carbon monoxide (DLco, corrected Hb) in a single breath is between 30% and 80% of the predicted value.
- •HRCT images completed within 12 months before screening can be used to determine UIP mode;
- •It is expected to complete the whole research plan, including 12 weeks of treatment and 1 week of follow-up;
- •Willing to follow all the requirements of drug use, visit and data collection during the study period;
- •Be able to understand the research content and sign the written informed consent;
- •Women of childbearing age provide negative pregnancy test results, and agree to take effective contraceptive measures during the study period and within 3 months after the last administration; Male subjects with fertility also need to take effective contraception at the same time.
排除标准
- •Suffering from other interstitial lung diseases caused by non-IPF reasons (such as connective tissue disease-related ILD, chronic allergic pneumonia, pneumoconiosis, drug-induced pneumonia, radiation lung disease, etc.);
- •One or more Acute Exacerbation)； of IPF occurred within 3 months before screening;
- •Have received a lung transplant;
- •Complicated with severe COPD(GOLD III and above), severe asthma or other airway diseases that may interfere with FVC determination;
- •The following systemic immunosuppressive treatments were used within 4 weeks before screening: > 15 mg/d prednisone (or equivalent dose), cyclophosphamide, methotrexate, tuzumab, rituximab, mycophenolate mofetil, etc.
- •Currently or in the past, allergic to Nidanib, dextromethorphan or any of its auxiliary ingredients;
- •The following laboratory abnormalities exist: ALT or AST >3×ULN；; eGFR <30 mL/min/1.73m²；
- •Have a history of uncontrolled mental illness, epilepsy, central nervous system dysfunction, or may induce adverse reactions after using dextromethorphan;
- •Being receiving drugs that may have serious drug interaction with dextromethorphan, such as monoamine oxidase inhibitor (MAOI) and selective serotonin reuptake inhibitor (SSRI), and unable to stop taking drugs;
- •Pregnant or lactating women;
- •At the time of screening, there are other major diseases or medical conditions that researchers think will significantly increase the risk and affect the treatment compliance or data interpretation;
- •Interventional treatment of other clinical trials within 4 weeks before screening.
- •Use Nidanib or pirfenidone for anti-fibrosis treatment within 8 weeks before screening;
研究者
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