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Nintedanib combined with or without Dextromethorphan for the treatment of IPF, with FVC as the primary efficacy endpoint to evaluate its effectivenes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Experimental: The dosage of Nintedanib is 150mg/100mg per dose, twice dailyï¼›The dosage of Dextromethorphan is 30mg per dose, twice daily. |
|
| Control group | Placebo Comparator | Control group:The dosage of Nintedanib is 150mg/100mg per dose, twice daily;Placebo take orally twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| FVC | The change in FVC from baseline at week 12 after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Leicester Cough score (LCQ) | Change in score from baseline to week 12 | |
| Symptoms and Effects Scale(L-PF) | Change in score from baseline to week 12 | |
| Incidence Rate of Acute Aggravating Events(%predicted) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
| D003915 | Dextromethorphan |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| 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. |
|
| Incidence Rate of Acute Aggravating Events during the 12-week study period |
| DLCO(%predictedl) | Change in score from baseline to week 12 |
| Incidence of Treatment-related adverse Events | The assessments need to be conducted four times at baseline and at weeks and 12 after medication |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |