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Efficacy & Safety of Nintedanib in Patients With Progressive Fibrosing Coal Mine Dust-Induced Interstitial Lung Disease

NCT05067517 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-02-24

No results posted yet for this study

Summary

Assess efficacy (as measured by annual rate of decline in FVC) and safety. The hypothesis is that nintedanib will be safe and effective therapy for patients with progressive fibrosing CMD-ILD over a period of 52 weeks. Test Article - Nintedanib 150 mg administered PO twice daily or matching placebo. A total of 160 patients meeting inclusion/exclusion criteria will be randomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily. A randomization scheme will be used that balances the group for potential confounders (proportion with PMF or small opacity-only PF-CMD\_ILD and proportion of ever- or never-smokers). The dose of the study drug may be reduced to 100 mg twice daily or interrupted temporarily to manage adverse events (AEs).

Conditions

  • Progressive Fibrosing Interstitial Lung Disease

Interventions

DRUG

Nintedanib

Randomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily.

DRUG

Placebo

Randomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily.

Sponsors & Collaborators

  • West Virginia University

    lead OTHER

Principal Investigators

  • Rahul Sangani, MD · West Virginia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05067517 on ClinicalTrials.gov