The safety and efficacy of nintedanib for patients with progressive fibrosing interstitial lung disease in a real world setting-a prospective observational study

The safety and efficacy of nintedanib for patients with progressive fibrosing interstitial lung disease in a real world setting-a prospective observational study - Nintedanib for PF-ILD in a real world setting

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041380

Enrollment

300

Registered

2020-08-11

Start date

2020-08-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Progressive fibrosing interstitial lung disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) A Patient who was clinically diagnosed with ILD (2) A Patient who was clinically diagnosed with PF-ILD (3) A Patient who will receive nintedanib within 1 month (4) Aged >=20 years and <85 years (5) A patient who agree that they participate by written consent

Exclusion criteria

Exclusion criteria: (1) Difficulty obtaining patients' consent (2) Severe heart disease (3) AST >=2*ULN, ALT >=2*ULN, or T-bil >=2*ULN (4) Pregnancy (5) Coexistence with pulmonary arterial hypertension, bronchial asthma, Malignant tumor, sarcoidosis, bronchiectasis, respiratory infection (6) A patient who already receive nintedanib or other anti-fibrotic agents (7) A patient with risk of fatal bleeding (8) Past history of thrombosis less than 3 months (9) A patient who started clinical trials less than 3 months (10) A patient improper to this clinical trial according to the decision of a principal investigator

Design outcomes

Primary

Measure	Time frame
The mortality rate by acute exacerbation of ILD	—

Secondary

Measure	Time frame
(1) FVC decline at 52 weeks from the initiation of nintedanib (2) Survival rate at 52 weeks (3) Incidence of adverse effects (>Grade 3) (4) PFS at 52 weeks (5) Change of FVC (6) Change of symptoms (dyspnea and cough) at 52 weeks (7) Change of DLCO, 6MWT, ABG, Aa-DO2, serum markers (8) Change of HRCT findings at 52 weeks (9) Change of PAP (10) Change of CTR-related findings and symptoms at 52 weeks (11) Persistency rate of treatment with nintedanib at 52 weeks (12) Survival time (13) Time to first acute exacerbation (14) Difference in the incidence and the fatality rate of acute exacerbation among primary disease (15) Association between disease phenotype and effectiveness of nintedanib (16) Association between pathological findings and effectiveness of nintedanib (17) Association between biomarker and effectiveness of nintedanib (18) FVC decline, survival rate, nintedanib continuation rate at 104, 156, 208, 260 weeks (19) Incidence of lung cancer development	—

Measure

Time frame

(1) FVC decline at 52 weeks from the initiation of nintedanib (2) Survival rate at 52 weeks (3) Incidence of adverse effects (>Grade 3) (4) PFS at 52 weeks (5) Change of FVC (6) Change of symptoms (dyspnea and cough) at 52 weeks (7) Change of DLCO, 6MWT, ABG, Aa-DO2, serum markers (8) Change of HRCT findings at 52 weeks (9) Change of PAP (10) Change of CTR-related findings and symptoms at 52 weeks (11) Persistency rate of treatment with nintedanib at 52 weeks (12) Survival time (13) Time to first acute exacerbation (14) Difference in the incidence and the fatality rate of acute exacerbation among primary disease (15) Association between disease phenotype and effectiveness of nintedanib (16) Association between pathological findings and effectiveness of nintedanib (17) Association between biomarker and effectiveness of nintedanib (18) FVC decline, survival rate, nintedanib continuation rate at 104, 156, 208, 260 weeks (19) Incidence of lung cancer development

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Countries

Japan

Contacts

Public ContactMotoyasu Kato

Juntendo University Hospital Department of Respiratory Medicine

mtkatou@juntendo.ac.jp03-3813-3111

Outcome results