Nintedanib With or Without Dextromethorphan in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorFirst Affiliated Hospital of Wenzhou Medical University

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

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations