Inhalation InjuryPhase 2NCT01287806
Ulinastatin in Inhalation Lung Injury
A Phase 2 study testing ulinastatin and blank group in people with Inhalation Injury, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inhalation Injury
- What is being tested?
- ulinastatin and blank group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or lactation
- Allergy for ulinastatin
- Received an investigational drug or device within 90 days prior to entering study
Trial locations and contacts
1 site in 1 country.
Sheng zhiyong, MD contact
Jia chiyu, MD contact
China1 site
304 hospital of PLA
Beijin, Beijin, 100000
Sheng zhiyong, MD, 86-13910008199
Jia chiyu, MD, JCY304@yahoo.com.cn
About this study
Official title: Multicenter,Randomized,Parallel Assignment,Blank Control Study of Ulinastatin in Inhalation Lung Injury
The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients.
- Conditions
- Inhalation Injury
- Being tested
- ulinastatin, blank group
- Keywords
- ulinastatin, inhalation injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulinastatinDrug
Also called brand name: noan
Resolved 4 vials of drugs in 100ml physiological saline solution,intravenously infused for 1-2h,tid,for continuous 10days
blank groupDrug
standard treatment
| Study group | Role | What they receive |
|---|---|---|
| blank control group | Sham comparator | Not described Receives: Drug: blank group |
| ulinastatin group | Experimental | ulinastatin is a multivalent kunitz-type serine protease inhibitor refined from human urine Receives: Drug: ulinastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: until death or discharge from hospital, data reviewed every 3 months
Secondary outcomes (5)
length of mechanical ventilation
Measured: from admission to 90 days
length of ICU stay
Measured: until death or discharge from hospital, data reviewed every 3 months
length of hospital stays
Measured: until death or discharge from hospital, data reviewed every 3 months
blood inflammatory mediator
Measured: 0days,5days and 10days
Bronchoscopy morphological evaluation
Measured: 0days,5days and 10days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhalation InjuryStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Southwest Hospital, China, General Hospital of Beijing PLA Military Region
- Investigators
- sheng zhiyong, MD, Study chair, First Hospitals affiliated to the China PLA General HospitalJia chiyu, MD, Principal investigator, First Hospitals affiliated to the China PLA General HospitalXia zhaofan, MD, Principal investigator, Changhai HospitalPang yizhi, MD, Principal investigator, Southwest Hospital, ChinaChen tunhu, MD, Principal investigator, General Hospital of Jinan PLA Military RegionZhu jinmin, MD, Principal investigator, General Hospital of Beijing PLA Military RegionLiu yi, MD, Principal investigator, General Hospital of Lanzhou PLA Military RegionCui xiaolin, MD, Principal investigator, Liaonin People's Armed Police Corps Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287806
- Sponsor's protocol ID
- Uilis-china
- Status last verified
- Jan 2011
- First submitted
- 24 Jan 2011
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter,Randomized,Parallel Assignment,Blank Control Study of Ulinastatin in Inhalation Lung Injury
- ClinicalTrials.gov ID
- NCT01287806
- Acronym / sponsor ID
- Uilis-china
- Conditions
- Inhalation Injury
- Keywords
- ulinastatin, inhalation injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, Southwest Hospital, China, General Hospital of Beijing PLA Military Region
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blank control group | Sham comparator | Drug: blank group |
| ulinastatin group | Experimental | Drug: ulinastatinulinastatin is a multivalent kunitz-type serine protease inhibitor refined from human urine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy or lactation
- Allergy for ulinastatin
- Received an investigational drug or device within 90 days prior to entering study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ulinastatinAlso: brand name: noanResolved 4 vials of drugs in 100ml physiological saline solution,intravenously infused for 1-2h,tid,for continuous 10days | Drug | ulinastatin group |
| blank groupstandard treatment | Drug | blank control group |
Primary outcome
all cause mortality
Time frame: until death or discharge from hospital, data reviewed every 3 months
5 secondary outcomes
length of mechanical ventilation
Time frame: from admission to 90 days
length of ICU stay
Time frame: until death or discharge from hospital, data reviewed every 3 months
length of hospital stays
Time frame: until death or discharge from hospital, data reviewed every 3 months
blood inflammatory mediator
Time frame: 0days,5days and 10days
Bronchoscopy morphological evaluation
Time frame: 0days,5days and 10days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng zhiyong, MD contact
Jia chiyu, MD contact
sheng zhiyong, MD study chair
First Hospitals affiliated to the China PLA General Hospital
Jia chiyu, MD principal investigator
First Hospitals affiliated to the China PLA General Hospital
Xia zhaofan, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ulinastatin and blank group in people with Inhalation Injury, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng zhiyong, MD (86-13910008199), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: until death or discharge from hospital, data reviewed every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2011.