Ulinastatin in Inhalation Lung Injury

Chinese PLA General Hospital (301 Hospital)

Status and phase: Unknown; Phase 2

Conditions: Inhalation Injury

Treatments: Drug: ulinastatin; Drug: blank group

Study type: Interventional

Funder types: Other

Identifiers

NCT01287806

Uilis-china

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe inhalation lung injury
• Within 48hours after inhalation injury
• Age 18 to 70 years old
• Burned area not more than 70% TBSA
• Signed the informed consent form

Exclusion criteria

• Pregnancy or lactation
• Allergy for ulinastatin
• Received an investigational drug or device within 90 days prior to entering study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

blank control group

Sham Comparator group

Treatment:

Drug: blank group

ulinastatin group

Experimental group

Description:

ulinastatin is a multivalent kunitz-type serine protease inhibitor refined from human urine

Treatment:

Drug: ulinastatin