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

ConditionIdiopathic 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Nintedanib,Dextromethorphan

    Drug

    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.

  • Nintedanib,Placebo

    Drug

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

FVC

Time frame
The change in FVC from baseline at week 12 after administration

Secondary outcomes

1

Leicester Cough score (LCQ)

Time frame
Change in score from baseline to week 12
2

Symptoms and Effects Scale(L-PF)

Time frame
Change in score from baseline to week 12
3

Incidence Rate of Acute Aggravating Events(%predicted)

Time frame
Incidence Rate of Acute Aggravating Events during the 12-week study period
4

DLCO(%predictedl)

Time frame
Change in score from baseline to week 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Wenzhou Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: