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

Official title

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.

Overview

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

Interventions

• Drug 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.
• Drug 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.

Primary outcome measures

• FVC [Time frame: The change in FVC from baseline at week 12 after administration]

Secondary outcome measures (5)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07583589 · Dextro-Nin-IPF-II

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗