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Evaluation of the efficacy and safety of add-on antifibrotic medications in inflammatory interstitial lung disease

A prospective, multi-center, randomized controlled clinical trial to evaluate the efficacy and safety of add-on antifibrotic medications in inflammatory interstitial lung disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105901
Enrollment
Unknown
Registered
2025-07-14
Start date
2025-07-15
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Inflammatory interstitial lung diseases

Interventions

Pirfenidone:Pirfenidone with standard treatment
Nintedanib:Nintedanib with standard treatment

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age>=18 years old; 2.Inflammatory interstitial lung disease diagnosed within recent 4 weeks, presenting with radiological and/or pathological pattern of organizing pneumonia (OP), cellular nonspecific interstitial pneumonia (cNSIP), or OP+cNSIP pattern; 3.Require corticosteroid and/or immunosuppressant treatment;

Exclusion criteria

Exclusion criteria: 1.Patients or their family members are unable to provide informed consent; 2.Presence of other severe comorbidities that the investigator believes may affect patient safety or compliance; 3.Pregnant or breastfeeding women, as well as patients who cannot effectively practice contraception during the study period and for 3 months after completion; 4.Malignancies requiring treatment; 5.Allergy to pirfenidone or nintedanib; 6.Need for endotracheal intubation with mechanical ventilation or ECMO support;

Design outcomes

Primary

MeasureTime frame
Forced Vital Capacity;

Countries

China

Contacts

Public Contacthui huang

Peking Union Medical College Hospital

pumchhh@126.com+86 10 6915 5039

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026