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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
Soft gelatin capsule
Soft gelatin capsule
China-Japan Friendship Hospital
Beijing, China
The Second Hospital of Jilin University
Changchun, China
Xiangya Hospital, Central South University
Changsha, China
West China Hospital
Chengdu, China
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Hangzhou First People's Hospital
Hangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Hospital
Hangzhou, China
Nanjing Drum Tower Hospital
Nanjing, China
Shanghai Chest Hospital
Shanghai, China
...and 6 more locations
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks Expressed in Milliliter (mL)
Annual rate of decline in FVC over 52 weeks expressed in milliliter (mL). The main analysis used a restricted maximum likelihood (REML)-based approach with a random slope and intercept model. The analysis included the fixed, categorical effects of treatment, high resolution computed tomography (HRCT) pattern at baseline, fixed continuous effects of time and baseline FVC as well as the treatment-by-time and baseline-by-time interactions. Random effects were included for the patient response for both time and intercept. For patients who prematurely discontinued study treatment, data collected at follow-up visit and visits after treatment discontinuation was included in the analysis.
Time frame: From baseline up to Week 52.
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