Idiopathic Pulmonary Fibrosis (IPF)Phase 2NCT07583589
Nintedanib With or Without Dextromethorphan in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing Nintedanib,Dextromethorphan in people with Idiopathic Pulmonary Fibrosis (IPF), run by First Affiliated Hospital of Wenzhou Medical University.
Trial summary
Nintedanib combined with or without Dextromethorphan for the treatment of IPF, with FVC as the primary efficacy endpoint to evaluate its effectivenes. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- Nintedanib,Dextromethorphan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2026to 1 Jun 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
About this study
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.
Nintedanib combined with or without Dextromethorphan for the treatment of IPF, with FVC as the primary efficacy endpoint to evaluate its effectivenes.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- Nintedanib,Dextromethorphan, Nintedanib,Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintedanib,DextromethorphanDrug
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.
Nintedanib,PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental: The dosage of Nintedanib is 150mg/100mg per dose, twice daily；The dosage of Dextromethorphan is 30mg per dose, twice daily. Receives: Drug: Nintedanib,Dextromethorphan |
| Control group | Placebo comparator | Control group：The dosage of Nintedanib is 150mg/100mg per dose, twice daily；Placebo take orally twice daily. Receives: Drug: Nintedanib,Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC
Measured: The change in FVC from baseline at week 12 after administration
Secondary outcomes (5)
Leicester Cough score (LCQ)
Measured: Change in score from baseline to week 12
Symptoms and Effects Scale(L-PF)
Measured: Change in score from baseline to week 12
Incidence Rate of Acute Aggravating Events(%predicted)
Measured: Incidence Rate of Acute Aggravating Events during the 12-week study period
DLCO(%predictedl)
Measured: Change in score from baseline to week 12
Incidence of Treatment-related adverse Events
Measured: The assessments need to be conducted four times at baseline and at weeks and 12 after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start12 May 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583589
- Sponsor's protocol ID
- Dextro-Nin-IPF-II
- Status last verified
- May 2026
- First submitted
- 4 Sep 2025
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No