About this trial
Nintedanib combined with or without Dextromethorphan for the treatment of IPF, with FVC as the primary efficacy endpoint to evaluate its effectivenes.
Eligibility criteria
Qualifiers
Age ≥40 years old, regardless of gender;
According to "2022 ATS/ERS/JRS/ALAT Guidelines", it was diagnosed as idiopathic pulmonary fibrosis (IPF);
Lung function meets the following conditions during screening: forced vital capacity (FVC) ≥45% predicted value; The dispersion of carbon monoxide (DLco, corrected Hb) in a single breath is between 30% and 80% of the predicted value.
HRCT images completed within 12 months before screening can be used to determine UIP mode;
Disqualifiers
Suffering from other interstitial lung diseases caused by non-IPF reasons (such as connective tissue disease-related ILD, chronic allergic pneumonia, pneumoconiosis, drug-induced pneumonia, radiation lung disease, etc.);
One or more Acute Exacerbation); of IPF occurred within 3 months before screening;
Have received a lung transplant;
Complicated with severe COPD(GOLD III and above), severe asthma or other airway diseases that may interfere with FVC determination;
Trial design
Treatments tested in this trial
- Nintedanib,Dextromethorphan
- Nintedanib,Placebo