CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
Nintedanibdrug
Likely dose
Nintedanib 100 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04702893
NCT04702893N/ACompleted

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

Boehringer Ingelheim·observational·Posted Jan 11, 2021·Updated Apr 25, 2025

In Brief

An observational study evaluating Nintedanib for Lung Diseases, Interstitial. Completed, enrolled 108 participants across 21 sites.

Detailed 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)).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJan 11, 2021
Enrollment StartMay 28, 2021
Primary CompletionApr 9, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.5 years ago

Interventions

Nintedanibdrug

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