progressive pulmonary fibrosis
Conditions
Interventions
Tryptophan Combined with Vitamin B6 + Standard Treatment Regimen Group for Progressive Pulmonary Fibrosis:Oral administration of 2g tryptophan and 40mg vitamin B6, divided into two doses (once in the
Placebo + Standard Treatment Regimen for Progressive Pulmonary Fibrosis:Oral administration of placebo, divided into two doses (once in the morning and once in the evening), in addition to the patient
Sponsors
Bethune Hospital of Shanxi Province
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years at the time of signing the informed consent form. 2. Written informed consent obtained before enrollment into the trial. 3. Diagnosed with progressive pulmonary fibrosis, excluding idiopathic pulmonary fibrosis. 4. Patients may be in either of the following states: a. On a stable treatment with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during the screening period, with plans to continue this treatment after randomization. (Stable treatment is defined as a tolerable course of nintedanib or pirfenidone without dose changes for at least 12 weeks); b. Not on treatment with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and during the screening period, with no plans to start treatment with nintedanib or pirfenidone. 5. Forced vital capacity (FVC) =45% of the predicted normal value at Visit 1. 6. Diffusion capacity =25% of the predicted normal value at Visit 1. 7. Patients receiving permitted immunosuppressive therapy (other than corticosteroids) to treat underlying systemic diseases (e.g., methotrexate, azathioprine) must have been on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following exclusion criteria will not be eligible for this clinical trial: 1. Patients in the acute exacerbation phase of pulmonary fibrosis. 2. Pregnant or lactating women; or patients planning to conceive during the trial period. 3. Patients with consciousness disorders, dementia, or various psychiatric diseases. 4. Patients with severe cardiac dysfunction, cerebrovascular disease, severe hematopoietic system disease, liver or kidney disease (ALT, AST, BUN, Cr more than 1.5 times the upper limit of normal), bronchial asthma, COPD, cancer, or pulmonary infection. 5. Patients known to be allergic to the components of the drugs used in the trial. 6. Patients who have undergone major or moderate surgery within 3 months prior to the screening examination. 7. Patients with poor compliance, making it difficult to determine the efficacy or completeness of the data, thus affecting the judgment of efficacy and safety. 8. Patients who have participated in other drug clinical trials within 3 months prior to the screening examination. 9. Patients who have long-term use (=2 weeks) of fibrosis-causing drugs such as amiodarone. 10. Patients deemed by the researcher to be unsuitable for participation in the trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absolute change in Forced Vital Capacity (FVC) in milliliters (mL) relative to baseline at week 25; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to the first occurrence of acute exacerbation of Interstitial Lung Disease (ILD), first hospitalization due to respiratory reasons, or death during the clinical trial period;Time from baseline to a decline of more than 10% in the predicted value of Forced Vital Capacity (FVC);Time from baseline to a decline of more than 15% in the predicted value of carbon monoxide diffusion capacity;The absolute change in the Pulmonary Fibrosis Quality of Life (QoL) Questionnaire score relative to baseline at week 25;The absolute change in the Leicester Cough Questionnaire (LCQ) score relative to baseline at week 25;The absolute change in the predicted value of FVC relative to baseline at week 25;The absolute change in the predicted value of carbon monoxide diffusion capacity relative to baseline at week 25; | — |
Countries
China
Contacts
Public ContactXiansheng Liu, Shuang Wei, Yi Wang
Bethune Hospital of Shanxi Province
Outcome results
None listed