The use of Anlotinib hydrochloride capsules for the treatment of IPF/PF-ILDs, with FVC as the primary efficacy endpoint to evaluate its effectivenes
Drug: Anlotinib The dose of nintedanib hydrochloride is 8mg per dose, taken orally once daily before breakfast. The drug is taken continuously for 2 weeks, followed by a 1-week break, until 24 weeks as the primary endpoint, to observe the long-term efficacy and safety of anlotinib in the treatment of IPF/PF-ILDs. After 24 weeks, the blinded administration was continued until 52 weeks. After 52 weeks, all subjects could enter the extension period if they wished. If a dose is missed and the next dose is due within 12 hours, it should not be made up. Drug: Placebo Placebo, taken orally once daily before breakfast. Taken continuously for 2 weeks, followed by a 1-week break, until 24 weeks as the primary endpoint, to observe the long-term efficacy and safety of anlotinib in the treatment of IPF/PF-ILDs. After 24 weeks, the blinded administration was continued until 52 weeks. After 52 weeks, all subjects could enter the extension period if they wished. If a dose is missed and the next dose is due within 12 hours, it should not be made up. FVC stands for forced vital capacity, which is typically the maximum amount of air that can be forcefully exhaled after taking a deep breath as quickly and completely as possible. This measure primarily assesses the ability to exhale as much air as possible in the shortest amount of time, and is used as an indicator of lung function.The change in FVC from baseline at week 52 after administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Drug: Anlotinib The dose of nintedanib hydrochloride is 8mg per dose, taken orally once daily before breakfast. The drug is taken continuously for 2 weeks, followed by a 1-week break, until 24 weeks as the primary endpoint, to observe the long-term efficacy and safety of anlotinib in the treatment of IPF/PF-ILDs. After 24 weeks, the blinded administration was continued until 52 weeks. After 52 weeks, all subjects could enter the extension period if they wished. If a dose is missed and the next dose is due within 12 hours, it should not be made up.
Placebo, taken orally once daily before breakfast. Taken continuously for 2 weeks, followed by a 1-week break, until 24 weeks as the primary endpoint, to observe the long-term efficacy and safety of anlotinib in the treatment of IPF/PF-ILDs. After 24 weeks, the blinded administration was continued until 52 weeks. After 52 weeks, all subjects could enter the extension period if they wished. If a dose is missed and the next dose is due within 12 hours, it should not be made up.
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGFVC
FVC stands for forced vital capacity, which is typically the maximum amount of air that can be forcefully exhaled after taking a deep breath as quickly and completely as possible. This measure primarily assesses the ability to exhale as much air as possible in the shortest amount of time, and is used as an indicator of lung function.
Time frame: 24weeks
FVC
FVC stands for forced vital capacity, which is typically the maximum amount of air that can be forcefully exhaled after taking a deep breath as quickly and completely as possible. This measure primarily assesses the ability to exhale as much air as possible in the shortest amount of time, and is used as an indicator of lung function.
Time frame: 52weeks
FVC(%predicted),
FVC (% predicted) was defined as forced vital capacity as a percentage of the predicted value.
Time frame: 24weeks、52weeks
FEV1
FEV1 (ml/s)was defined as forced expiratory volume in one second.
Time frame: 24weeks、52weeks
FEV1 %predicted
FEV1 (% predicted)was forced expiratory volume in one second as a percentage of the predicted value .
Time frame: 24weeks、52weeks
TLC(ml)
TLC(ml) was defined as Total Lung Capacity.
Time frame: 24weeks、52weeks
TLC % predicted
TLC (% predicted) was defined as total lung capacity as a percentage of the predicted value.
Time frame: 24weeks、52weeks
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DLco%predicted
DLco%predicted was diffusing capacity of the lung for carbon monoxide as a percentage of the predicted value.
Time frame: 24weeks、52weeks
6-minute walk test
6-minute walk test is a commonly used method to evaluate physical function and cardiorespiratory health status. The walk distance, usually measured in feet or meters, is an important indicator of the test. It refers to the total distance covered by the subject within 6 minutes, which can reflect their endurance and exercise capacity.
Time frame: 24weeks、52weeks
HRCT
Relative change from baseline in HRCT.
Time frame: 24weeks、52weeks