New combo aims to slow lung scarring in IPF patients

NCT ID NCT07583589

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding dextromethorphan to the standard drug nidanib helps people with idiopathic pulmonary fibrosis (IPF). About 60 adults aged 40 and older will take either the combo or nidanib alone for 12 weeks. The main goal is to see if lung function (FVC) improves or declines less, with cough and side effects also tracked.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nidanib and dextromethorphan
What this could lead to
If it works, this could point toward a better treatment for IPF that slows lung decline and reduces coughing.
What could go wrong
This is a small, early-phase trial with only 60 people. The combination may not work better than nidanib alone, and side effects like stomach issues are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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