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The clinical significance of dextromethorphan combined with pirfenidone in fibrotic interstitial lung disease

The clinical significance of dextromethorphan combined with pirfenidone in fibrotic interstitial lung disease

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126152
Enrollment
Unknown
Registered
2026-06-04
Start date
2024-12-26
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial lung disease

Interventions

Observation group (CET score >= 9):None
Pirfenidonegroup:None

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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

MeasureTime frame
Chest HRCT;Pulmonary Function;

Secondary

MeasureTime frame
blood routine, Liver Function,Renal Function;Six-Minute Walk Distance (6MWD);Cough Score;

Countries

China

Contacts

Public ContactJing Feng

Tianjin Medical University General Hospital

fengjing1974@163.com+86 139 2050 0251

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026