Interstitial lung disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 40–80 years at the time of informed consent signing. 2. Diagnosis of fibrotic interstitial lung disease confirmed by HRCT imaging, with radiographic fibrosis >10%. 3. FVC% predicted between 45% and 80%, and DLco% predicted between 25% and 80% at screening. 4. Able to complete pulmonary function testing. 5. Female subjects of childbearing potential must agree to use effective contraception during the study period.
Exclusion criteria
Exclusion criteria: 1. Allergy to dextromethorphan, pirfenidone, or any of their excipients. 2. History of acute exacerbation within the past six months. 3. Initiation or escalation (higher dose or additional medication) of steroid-sparing immunosuppressive therapy within one month prior to screening. Permitted prior to study enrollment: stable doses of azathioprine, mycophenolate mofetil, or prednisone (1 month. Severe concomitant conditions: hepatic or renal insufficiency, active infection, heart failure (NYHA Class III-IV). 4. Use of monoamine oxidase inhibitors (MAOIs) or discontinuation <2 weeks prior (due to serious interaction risk with dextromethorphan); 5. Active psychiatric illness or history of epilepsy (potential central nervous system effects of dextromethorphan); 6. Life expectancy <12 months (for reasons unrelated to pulmonary fibrosis); 7. Undergone lung transplant evaluation or placement on transplant waiting list within the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chest HRCT;Pulmonary Function; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood routine, Liver Function,Renal Function;Six-Minute Walk Distance (6MWD);Cough Score; | — |
Countries
China
Contacts
Tianjin Medical University General Hospital