Phase II study of concurrent induction therapy with nintedanib and anti-inflammatory therapy in untreated progressive pulmonary fibrosis patients - TOP-ILD study

Okamoto Isamu0 sites32 target enrollmentApril 10, 2023

ConditionsProgressive pulmonary fibrosis interstitial pneumonia, IP, PPF

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Progressive pulmonary fibrosis
Sponsor: Okamoto Isamu
Enrollment: 32
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 10, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Okamoto Isamu

Eligibility Criteria

Inclusion Criteria

•1\) Patients who are 20 years of age or older at the time of obtaining consent.
•2\) Patients who are not receiving any treatment for interstitial lung disease, such as antifibrotic agents, immunosuppressive agents, or steroids..
•3\) Patients diagnosed with idiopathic non\-specific interstitial pneumonia (iNSIP), unclassifiable idiopathic interstitial pneumonia, fibrotic hypersensitivity pneumonitis, or rheumatoid arthritis\-associated interstitial lung disease (RA\-ILD) and meeting the following progressive criteria within 12 months of observation period (since the test that was the starting point for the diagnosis of PPF) prior to enrollment.
•Progressive pulmonary fibrosis (PPF) in this study must meet at least 2 of the following 3 criteria, including ii)
•i) Worsening of respiratory symptoms
•ii) A decline in lung function as measured by at least 5% (relative change) of %FVC or 15% (relative change) of %DLco corrected for Hb concentration.
•iii) An increase in fibrotic changes on chest imaging
•4\) Patients with pulmonary fibrosis exceeding at least 10% of the total lung field on HRCT as assessed by the physician in charge on HRCT images (since the test that was the starting point for the diagnosis of PPF). Fibrosis of the lungs is defined as including reticular shadows or traction bronchiectasis, with or without honeycomb lung findings.
•5\) Patients with %FVC greater than 50%.
•6\) Patients with a %DLco greater than 30% and less than 80% corrected for hemoglobin (Hb) concentration

Exclusion Criteria

•1\) Patients diagnosed with IPF, COP, AIP, DIP, RB\-ILD, LIP and PPFE
•2\) Patients with interstitial lung disease associated with collagen diseases except rheumatoid arthritis (including cases of overlap syndrome (e.g., Sjogren's syndrome in rheumatoid arthritis patients)) and interstitial lung disease with causes other than fibrotic hypersensitivity pneumonitis
•3\) Patients already receiving steroids, immunosuppressants (tacrolimus, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil,etc.), or antifibrotic agents at the time of enrollment
•4\) Patients with a history of acute exacerbation of interstitial lung disease
•5\) Patients with poorly controlled diabetes mellitus
•(\>\=HbA1c 8\.0%)
•6\) Patients with predominant airflow obstruction (FEV1/FVC less than 0\.7 within 30 days prior to enrollment)
•7\) Patients with complications of acute and chronic systemic infections (e.g., non\-tuberculous mycobacterial infections)
•8\) Patients with acute and chronic pancreatitis
•9\) Patients with a history of or complications of myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure (New York Heart Association (NYHA) Class III or IV) within 180 days prior to enrollment.