Experimental Lung InflammationNCT01714427
Validation of a Lung Inflammation Model in Healthy Volunteers by Radiological Tools and Glucocorticoid Treatment
A study testing Dexamethasone and Sterile isotonic saline in people with Experimental Lung Inflammation, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to investigate the local and systemic inflammatory response and haemostatic alterations in the lungs after lipopolysaccharide (LPS) instillation and to determine the feasibility of imaging techniques to quantify lung inflammation in an adapted human endotoxin instillation model. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Experimental Lung Inflammation
- What is being tested?
- Dexamethasone and Sterile isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2011to Jun 2012
- Phase
- Interventional
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent obtained before any trial-related activities. (Trial activities are any procedure that would not have been performed during normal management of the subject).
- Nonsmoker
- Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- If female and of childbearing potential and subjects agrees to employ adequate birth control measures (e. g. oral contraceptives, barrier method)
- Negative urine pregnancy test
Who cannot join
- Known or suspected allergy to trial product or related products
- Pregnancy or Lactation
- Treatment with an investigational drug within three weeks prior to this trial
- Participation in an LPS trial within the last 6 weeks
- Smoking
- History of relevant cardiac arrhythmia
Show all 20Show fewer
- Preexisting open or closed angle glaucoma
- History of Osteoporosis, Cushing´s syndrome, gastro-duodenal ulcera, cardiovascular disease, vasculitis, diabetes mellitus, hypertension, brain tumor or history of neurosurgery
- Systemic tuberculosis
- Hemorrhagic diathesis
- Relevant liver or kidney dysfunction
- Regular use of medication or abuse of alcohol unless considered clinically relevant
- Use of any medication within one week prior to the first trial day
- Symptoms of a clinically relevant illness in the 3 weeks before the first trial day
- Excessive sporting activities
- Rosacea
- Subjects on Monoamine oxidase inhibitors (should be stopped for at least two to three weeks before dihydrocodeine treatment is initiate)
- Known acute or active hepatic disease within the past 3 months
- A platelet count < 100,000 x 106/L, prothrombin time > 1.5, liver enzymes> 3 times the upper normal limit
- Having received a vaccination up to 8 weeks before the trial
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
The purpose of this study is to investigate the local and systemic inflammatory response and haemostatic alterations in the lungs after lipopolysaccharide (LPS) instillation and to determine the feasibility of imaging techniques to quantify lung inflammation in an adapted human endotoxin instillation model.
The investigators will also explore whether glucocorticoid treatment can blunt LPS effects.
- Conditions
- Experimental Lung Inflammation
- Being tested
- Dexamethasone, Sterile isotonic saline
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Two doses of 40mg dexamethasone (in 100 ml physiologic saline solution, respectively) will be administered intravenously prior to LPS instillation.
Sterile isotonic salineDrug
two doses of 100 ml physiologic saline solution will be administered intravenously prior to LPS instillation.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Not described Receives: Drug: Dexamethasone |
| Sterile isotonic saline | Placebo comparator | Not described Receives: Drug: Sterile isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of LPS instillation on a putative microvascular leak formation in a lung subsegment by radiologic imaging (magnetic resonance imaging, computed tomography) will be quantified.
Measured: 6/24 hours after LPS Instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startJul 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Experimental Lung InflammationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernd Jilma, Medical University of Vienna
- Investigators
- Bernd Jilma, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna, Waehringerguertel 18-20, A-1090 Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714427
- Sponsor's protocol ID
- DEXA - LIM
- Status last verified
- Apr 2013
- First submitted
- 6 Sep 2011
- Last updated
- 24 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Lung Inflammation Model in Healthy Volunteers by Radiological Tools and Glucocorticoid Treatment
- ClinicalTrials.gov ID
- NCT01714427
- Acronym / sponsor ID
- DEXA - LIM
- Conditions
- Experimental Lung Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Oct 2012 (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 investigate the local and systemic inflammatory response and haemostatic alterations in the lungs after lipopolysaccharide (LPS) instillation and to determine the feasibility of imaging techniques to quantify lung inflammation in an adapted human endotoxin instillation model.
The investigators will also explore whether glucocorticoid treatment can blunt LPS effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: Dexamethasone |
| Sterile isotonic saline | Placebo comparator | Drug: Sterile isotonic saline |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed informed consent obtained before any trial-related activities. (Trial activities are any procedure that would not have been performed during normal management of the subject).
- Nonsmoker
- Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- If female and of childbearing potential and subjects agrees to employ adequate birth control measures (e. g. oral contraceptives, barrier method)
Key exclusion criteria (20 listed)
- Known or suspected allergy to trial product or related products
- Pregnancy or Lactation
- Treatment with an investigational drug within three weeks prior to this trial
- Participation in an LPS trial within the last 6 weeks
- Smoking
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 |
|---|---|---|
| DexamethasoneTwo doses of 40mg dexamethasone (in 100 ml physiologic saline solution, respectively) will be administered intravenously prior to LPS instillation. | Drug | Dexamethasone |
| Sterile isotonic salinetwo doses of 100 ml physiologic saline solution will be administered intravenously prior to LPS instillation. | Drug | Sterile isotonic saline |
Primary outcome
The effects of LPS instillation on a putative microvascular leak formation in a lung subsegment by radiologic imaging (magnetic resonance imaging, computed tomography) will be quantified.
Time frame: 6/24 hours after LPS Instillation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2013.
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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.
Bernd Jilma, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna, Waehringerguertel 18-20, A-1090 Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Sterile isotonic saline in people with Experimental Lung Inflammation, run by Medical University of Vienna at 1 site in Austria.
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 6 inclusion and 20 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: finished, as of the sponsor's last update on 24 Apr 2013. 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 Austria. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of LPS instillation on a putative microvascular leak formation in a lung subsegment by radiologic imaging (magnetic resonance imaging, computed tomography) will be quantified. (time frame: 6/24 hours after LPS Instillation). 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 24 Apr 2013.