Idiopathic pulmonary fibrosis and fibrotic interstitial lung disease caused by various types of interstitial pneumonia
Conditions
Interventions
Experimental group:Domiciliary High flow nasal cannula
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with idiopathic pulmonary fibrosis or fibrotic interstitial lung disease in a stable phase; 2. Patients with moderate hypoxemia at rest (SpO2 89%-93%) or moderate exercise-induced hypoxemia (SpO2 >=80% for >=5 minutes, and =10 seconds); 3. Male or female patients aged 18 or older; 4. Smokers who have quit for more than 3 months; 5. If the patient is on steroids, the dose should be <=3 tablets/day for more than 1 month.
Exclusion criteria
Exclusion criteria: 1.Patients deemed by the treating physician to have poor adherence. 2.Inability to complete pulmonary function tests or study-related questionnaire assessments (e.g., due to severe pulmonary impairment, significant motor impairment from prior stroke, cognitive impairment). 3.Severe nasal obstruction or inability to tolerate high-flow nasal cannula (HFNC) therapy. 4.Investigator assessment of poor baseline condition precluding participation in follow-up visits at 3 and 6 months. 5.Acute exacerbation of interstitial pneumonia within 1 month prior to screening and/or during the screening period. 6.Acute pulmonary embolism within 1 month prior to screening. 7.Uncontrolled infectious diseases, including active tuberculosis, active hepatitis B or C, HIV infection, or syphilis. 8.History or current diagnosis of malignancy, except for subjects who have achieved complete remission >5 years prior to screening and require no further active treatment or are not expected to require treatment during the study period. 9.History of myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, heart failure (New York Heart Association functional class > II), transient ischemic attack, cerebral infarction, cerebral hemorrhage, or subarachnoid hemorrhage within the preceding 3 months; 10.Considered by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Walking Distance of 6 minute walk; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Score;deaths;the change of DLCO SB (Hb corrected) per predicted from baseline;number of patients undergoing lung transplant;how many times of AE-ILD;days to the first AE-ILD;Change of fibrotic lesion from baseline on HRCT;pulmonary hypertension, including number of patients with new onset PH, and PH change from baseline;HAD score;Time to normal oxygen saturation after 6 minute walking test;life quality, St. George's Dyspnea Questionnaire;the absolute change of FVC per predicted from baseline; | — |
Countries
China
Contacts
Public ContactHuaping Dai
China-Japan Friendship Hospital
Outcome results
None listed