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

May 8, 2026 updated by: First Affiliated Hospital of Wenzhou Medical University

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.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥40 years old, regardless of gender;
  2. According to "2022 ATS/ERS/JRS/ALAT Guidelines", it was diagnosed as idiopathic pulmonary fibrosis (IPF);
  3. 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.
  4. HRCT images completed within 12 months before screening can be used to determine UIP mode;
  5. It is expected to complete the whole research plan, including 12 weeks of treatment and 1 week of follow-up;
  6. Willing to follow all the requirements of drug use, visit and data collection during the study period;
  7. Be able to understand the research content and sign the written informed consent;
  8. 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:

  1. 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.);
  2. One or more Acute Exacerbation)； of IPF occurred within 3 months before screening;
  3. Have received a lung transplant;
  4. Complicated with severe COPD(GOLD III and above), severe asthma or other airway diseases that may interfere with FVC determination;
  5. 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.
  6. Currently or in the past, allergic to Nidanib, dextromethorphan or any of its auxiliary ingredients;
  7. The following laboratory abnormalities exist: ALT or AST >3×ULN；; eGFR <30 mL/min/1.73m²；
  8. Have a history of uncontrolled mental illness, epilepsy, central nervous system dysfunction, or may induce adverse reactions after using dextromethorphan;
  9. 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;
  10. Pregnant or lactating women;
  11. 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;
  12. Interventional treatment of other clinical trials within 4 weeks before screening.
  13. Use Nidanib or pirfenidone for anti-fibrosis treatment within 8 weeks before screening;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Experimental: The dosage of Nintedanib is 150mg/100mg per dose, twice daily；The dosage of Dextromethorphan is 30mg per dose, twice daily.
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.
Placebo Comparator: Control group
Control group：The dosage of Nintedanib is 150mg/100mg per dose, twice daily；Placebo take orally twice daily.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
FVC
Time Frame: The change in FVC from baseline at week 12 after administration
The change in FVC from baseline at week 12 after administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Leicester Cough score (LCQ)
Time Frame: Change in score from baseline to week 12
Change in score from baseline to week 12
Symptoms and Effects Scale(L-PF)
Time Frame: Change in score from baseline to week 12
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
Incidence Rate of Acute Aggravating Events during the 12-week study period
DLCO(%predictedl)
Time Frame: Change in score from baseline to week 12
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
The assessments need to be conducted four times at baseline and at weeks and 12 after medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dextro-Nin-IPF-II

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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