Nintedanib combined with or without Dextromethorphan for the treatment of IPF, with FVC as the primary efficacy endpoint to evaluate its effectivenes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Dosage of Nitedanib is 150mg/100mg each time, twice a day, once in the morning and once in the evening, It is recommended to take it with meals. The dosage of Dextromethorphan sustained-release tablets is 30 mg, twice a day. It is recommended to take it orally 30 minutes after meals. For 12 weeks.
Dosage of Nitedanib is 150mg/100mg each time, twice a day, once in the morning and once in the evening, with an interval of 12hours. It is recommended to take it with meals to reduce gastrointestinal adverse reactions. Placebo, twice a day, recommended to be taken in the morning and evening. For 12 weeks.
FVC
Time frame: The change in FVC from baseline at week 12 after administration
Leicester Cough score (LCQ)
Time frame: Change in score from baseline to week 12
Symptoms and Effects Scale(L-PF)
Time frame: Change in score from baseline to week 12
Incidence Rate of Acute Aggravating Events(%predicted)
Time frame: Incidence Rate of Acute Aggravating Events during the 12-week study period
DLCO(%predictedl)
Time frame: Change in score from baseline to week 12
Incidence of Treatment-related adverse Events
Time frame: The assessments need to be conducted four times at baseline and at weeks and 12 after medication
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