NCT04702893

INREAL - Nintedanib for Changes in Dyspnea and Cough in Patients Suffering From Chronic Fibrosing Interstitial Lung Disease (ILD) With a Progressive Phenotype in Everyday Clinical Practice: a Real-world Evaluation

Prospective Observational Investigation of Possible Correlations Between Change in FVC and Change in Cough or Dyspnea Scores Using the Living With Pulmonary Fibrosis Questionnaire (L-PF) Between Baseline and After Approximately 52 Weeks of Nintedanib Treatment in Patients Suffering From Chronic Fibrosing ILD With a Progressive Phenotype

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this observational study is to investigate the correlation between changes from baseline at 52 weeks in forced vital capacity (FVC) and changes from baseline at 52 weeks in dyspnea score points or cough score points as measured with the pulmonary fibrosis questionnaire (L-PF) questionnaire over 52 weeks of nintedanib treatment in patients suffering from chronic fibrosing interstitial lung disease (ILD) with a progressive phenotype (excluding idiopathic pulmonary fibrosis (IPF)).

Conditions

• Lung Diseases, Interstitial

Interventions

Type	Name	Description
DRUG	Nintedanib	150 or 100 milligrams (mg) of nintedanib, when 150 mg is not tolerated, twice daily, administered 12 hours apart, according to the approved label.

Timeline

• Start date: 2021-05-28
• Primary completion: 2024-04-09
• Completion: 2024-04-09
• First posted: 2021-01-11
• Last updated: 2025-04-25
• Results posted: 2025-04-25

Locations

21 sites across 1 country: Germany