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Pirfenidone inhibits airway fibrosis (IPAF): a prospective, observational, controlled study

Preliminary study for the effect of pirfenidone combined with airway intervention on airway fibrosis

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024441
Enrollment
Unknown
Registered
2019-07-12
Start date
2019-07-15
Completion date
Unknown
Last updated
2019-07-15

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

Conditions

Airway fibrosis

Interventions

Control group:Conventional airway interventional therapy
Pirfenidone treatment group:Conventional airway intervention + pirfenidone

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years; 2. Patients with benign fibrous scar hyperplasia in the central airway after IV-type tracheal-bronchial tuberculosis, tracheal intubation/tracheal incision, and stent placement in the past 12 months; 3. Voluntary admission to airway intervention and 24 weeks of pirfenidone treatment.

Exclusion criteria

Exclusion criteria: 1. Poor compliance, refusal to receive airway interventional therapy and pirfenidone treatment; 2. The presence of contraindications to pirfenidone such as patients with toxic liver disease, severe renal dysfunction or need to dialysis patients, taking fluvoxamine; 3. Combined with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system, mental patients and serious diseases affecting their quality of life; 4. Patient Mycobacterium tuberculosis (+); 5. Type I, II, III, VI tracheobronchial tuberculosis; 6. Nintedanib, local injection of triamcinolone acetonide, paclitaxel-washing stent or intra-airway radiotherapy and other drugs that inhibit scar hyperplasia; 7. Subjects who are participating in other drug clinical trials or intervention studies.

Design outcomes

Primary

MeasureTime frame
stability of the two groups of fibrous scar hyperplasia;

Secondary

MeasureTime frame
Changes in the degree of central airway stenosis;Reduction of sputum retention;Number of obstructive pneumonias;Changes in dyspnea index (mMRC);Changes in lung function;6 minutes walking distance change;SGRQ;

Countries

China

Contacts

Public ContactGuo Shuliang

The First Affiliated Hospital of Chongqing Medical University

guosl999@sina.com+86 13101363078

Outcome results

None listed

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