Nintedanib With or Without Dextromethorphan in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Официальное название

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.

Обзор

Nintedanib combined with or without Dextromethorphan for the treatment of IPF, with FVC as the primary efficacy endpoint to evaluate its effectivenes.

Вмешательства

• Препарат Nintedanib,Dextromethorphan
  Dosage of Nitedanib is 150mg/100mg each time, twice a day, once in the morning and once in the evening, It is recommended to take it with meals. The dosage of Dextromethorphan sustained-release tablets is 30 mg, twice a day. It is recommended to take it orally 30 minutes after meals. For 12 weeks.
• Препарат Nintedanib,Placebo
  Dosage of Nitedanib is 150mg/100mg each time, twice a day, once in the morning and once in the evening, with an interval of 12hours. It is recommended to take it with meals to reduce gastrointestinal adverse reactions. Placebo, twice a day, recommended to be taken in the morning and evening. For 12 weeks.

Первичные конечные точки

• FVC [Срок оценки: The change in FVC from baseline at week 12 after administration]

Вторичные конечные точки (5)

• Leicester Cough score (LCQ) [Срок оценки: Change in score from baseline to week 12]
• Symptoms and Effects Scale(L-PF) [Срок оценки: Change in score from baseline to week 12]
• Incidence Rate of Acute Aggravating Events(%predicted) [Срок оценки: Incidence Rate of Acute Aggravating Events during the 12-week study period]
• DLCO(%predictedl) [Срок оценки: Change in score from baseline to week 12]
• Incidence of Treatment-related adverse Events [Срок оценки: The assessments need to be conducted four times at baseline and at weeks and 12 after medication]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07583589 · Dextro-Nin-IPF-II

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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