New combo aims to slow lung scarring in IPF patients
NCT ID NCT07583589
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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