A pilot study of the efficacy and safety of sivelestat sodium hydrate to prevent acute exacerbation after thoracoscopic lung biopsy in patients suspected of interstitial lung diseases whose bronchoalveolar fluid showed neutrophils.

A pilot study of the efficacy and safety of sivelestat sodium hydrate to prevent acute exacerbation after thoracoscopic lung biopsy in patients suspected of interstitial lung diseases whose bronchoalveolar fluid showed neutrophils. - The evaluation of prophylactic effect of sivelestat sodium hydrate against acute exacerbation after video-assisted thoracic surgery (VATS) in the patients suspected of interstitial lung diseases.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006148

Enrollment

Registered

2011-08-11

Start date

2011-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

interstitial lung disease

Interventions

Sivelestat is administered 0.2 mg/ kg/ h for the duration of less than 14 days just after VATS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients 20<=and<=75 years old 2) Patients with neutrophils in bronchoalveolar lavage fluid (regardless of the proportion) 3) Inpatient 4) Patients who are suspected to be interstitial lung disease and undergoing VATS 5) Patients who offer a documented agreement to the study

Exclusion criteria

Exclusion criteria: 1) Patients complicated by four or more organ failures including lungs 2) Patients in pregnancy, lactation, or possible pregnancy 3) Patients to whom the physician in-charge judged not suitable for the study 4) Patients using steroid 5) Patients who against or depart gravely from the protocol in dose, dosing schedule, and/or the combination of therapy

Design outcomes

Primary

Measure	Time frame
The incidence of acute exacerbation for 2 weeks after VATS	—

Secondary

Measure	Time frame
<Efficacy endpoints> AUCPaO2(0-14day) Transition of various bio-markers in blood (LDH, CRP, SP-D, KL-6, HO (hemeoxygenase)-1, etc.) BALF findings (Total cell count, Cell fraction, LDH/TP/Alb&#61655;CD4/8 ratio&#61655;HO-1) Improvement in ground glass opacity in chest CT (Imaging site: the top of aortic bulb, carina and 1cm above the left diaphragmatic top) Improvement in the accumulation at lungs using gallium scintigraphy (-~+~+++) Pulmonary function test (FVC, VC, DLco, DLco/VA) AUCSpO2 in 6-min walk test (room air) Blood gas analysis The correlation between VATS findings (cellular infiltration into alveolar space) and the improvement in the disease activity. The correlation between HO-1 immunohistochemical staining and the improvement in the disease activity. The correlation of the neutophil counts in the BALF and the improvement in the disease activity. The incidence of acute exacerbation of interstitial pneumonia after 3 and 6 months Acute exacerbation is diagnosed when a patient meets all the following criteria: 1) increased dyspnea, 2) honeycomb lung and new ground glass opacity / infiltration and 3) decreased arterial oxygen fraction (PaO2: 10 Torr under the same condition. Marked pulmonary infection, pneumothorax, malignant tumor, pulmonary embolism and heart failure are excluded.) <Safety endpoint> The number and the rate of incidents item by item for each adverse event.	—

Measure

Time frame

<Efficacy endpoints> AUCPaO2(0-14day) Transition of various bio-markers in blood (LDH, CRP, SP-D, KL-6, HO (hemeoxygenase)-1, etc.) BALF findings (Total cell count, Cell fraction, LDH/TP/Alb&#61655;CD4/8 ratio&#61655;HO-1) Improvement in ground glass opacity in chest CT (Imaging site: the top of aortic bulb, carina and 1cm above the left diaphragmatic top) Improvement in the accumulation at lungs using gallium scintigraphy (-~+~+++) Pulmonary function test (FVC, VC, DLco, DLco/VA) AUCSpO2 in 6-min walk test (room air) Blood gas analysis The correlation between VATS findings (cellular infiltration into alveolar space) and the improvement in the disease activity. The correlation between HO-1 immunohistochemical staining and the improvement in the disease activity. The correlation of the neutophil counts in the BALF and the improvement in the disease activity. The incidence of acute exacerbation of interstitial pneumonia after 3 and 6 months Acute exacerbation is diagnosed when a patient meets all the following criteria: 1) increased dyspnea, 2) honeycomb lung and new ground glass opacity / infiltration and 3) decreased arterial oxygen fraction (PaO2: 10 Torr under the same condition. Marked pulmonary infection, pneumothorax, malignant tumor, pulmonary embolism and heart failure are excluded.) <Safety endpoint> The number and the rate of incidents item by item for each adverse event.

—

Countries

Japan

Contacts

Public ContactMasaharu Shinkai

Yokohama City University Medical Center Respiratory Disease Center

shinkai@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026