drugset / Trial / NCT05065190

A Study to Test How Well a Medicine Called Nintedanib Helps People in China With Progressive Lung Fibrosis

NCT05065190

Phase 3 Completed 81 enrolled Boehringer Ingelheim
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study in China is open to people with progressive lung fibrosis (chronic fibrosing ILDs with progressive phenotype) who are at least 18 years old. The purpose of this study is to find out whether a medicine called nintedanib helps people with progressive lung fibrosis. Participants are put into 2 groups randomly, which means by chance. 1 group gets nintedanib as capsules twice a day. The other group gets placebo as capsules twice a day. Placebo capsules look like nintedanib capsules but do not contain any medicine. Participants are in the study for about 1 year. During this time, they visit the study site about 10 times. At some visits, participants perform a lung function test. The doctors check whether study treatment can slow down the loss of lung function. The doctors also regularly check participants' health and take note of any unwanted effects.

Timeline

Start
2021-11-25
Primary completion
2024-04-30
Completion
2024-05-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Nintedanib Small molecule 150 mg Oral