NCT05065190

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

A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Chinese Patients With Chronic Fibrosing ILDs With a Progressive Phenotype

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Diseases, Interstitial

Interventions

Type	Name	Description
DRUG	Nintedanib	Soft gelatin capsule
DRUG	Placebo	Soft gelatin capsule

Timeline

• Start date: 2021-11-25
• Primary completion: 2024-04-30
• Completion: 2024-05-07
• First posted: 2021-10-01
• Last updated: 2025-05-20
• Results posted: 2025-05-20

Locations

16 sites across 1 country: China