InflammationNCT01081392
Inflammatory Markers in Sputum After LPS Inhalation
A study testing LPS in people with Inflammation, run by Centre Hospitalier Universitaire Brugmann at 1 site in Belgium.
Trial summary
The purpose of the study is to measure inflammatory biomarkers in sputum and peripheral blood in healthy volunteers after inhalation of single doses of LPS (20 mcg) administered as particles of different sizes. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- LPS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2010to May 2010
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteer, non-smoking or ex-smoker >1mth and <10packs/year
- normal ECG
- normal lab values for hematology, ionogram, AST, ALT, alk phosphatases, urea, creatinine and CRP
- FEV1/forced vital capacity >0.7 and FEV1>80% of predicted value
- able to produce valid sputum following induction (>=50% viable cells, <50% squamous cells and <60% neutrophils)
- females must be using contraception
- written informed consent
Who cannot join
- infection within 14 days
- history of bronchial asthma
- obstructive respiratory condition with FEV1 <70% of theoretical value
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Inhaled Particle Size on the Inflammatory Response Induced by Endotoxin Inhalation
The purpose of the study is to measure inflammatory biomarkers in sputum and peripheral blood in healthy volunteers after inhalation of single doses of LPS (20 mcg) administered as particles of different sizes.
Read the detailed description
Endotoxins are inflammatory substances present in the environment. In man, the inhalation of the lipopolysaccharride moiety (LPS) induces measurable immune responses. With an inhaled single dose of 20 micron, the inflammatory response in man is sub-clinical. During bronchoprovocation tests with allergens, the particle size determines to a large extent the intensity of the response. the response to LPS as a function of particle size is not known and will be studied in this study.
- Conditions
- Inflammation
- Being tested
- LPS
- Keywords
- LPS, endotoxin, inflammatory markers, healthy volunteers, neutrophils in sputum
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPSBiological
LPS 20mcg sd inhaled via nebulizer, 3 periods
| Study group | Role | What they receive |
|---|---|---|
| LPS sequence 1 | Experimental | Nebulizers A then B then C Receives: Biological: LPS |
| LPS sequence 2 | Experimental | Nebulizers B then C then A Receives: Biological: LPS |
| LPS sequence 3 | Experimental | Nebulizers C then A then B Receives: Biological: LPS |
| LPS sequence 4 | Experimental | Nebulizers A then C then B Receives: Biological: LPS |
| LPS sequence 5 | Experimental | Nebulizers C then B then A Receives: Biological: LPS |
| LPS sequence 6 | Experimental | Nebulizers B then A then C Receives: Biological: LPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute neutrophil count in sputum
Measured: 24hrs after LPS inhalation
Secondary outcomes (9)
white blood cells and differential in peripheral blood
Measured: 0, 6 and 24 hrs after LPS inhalation
CC16 in peripheral blood
Measured: 0, 6 and 24hrs after LPS inhalation
Calgranulin A/B
Measured: 0, 6 and 24hrs after LPS inhalation
CRP in peripheral blood
Measured: 0, 6 and 24hrs after LPS inhalation
Spirometry (FEV1 and FEV1/FEV)
Measured: 0, 1, 6 and 24hrs after LPS inhalation
Alveolo-capillary diffusion
Measured: 0, 6 and 24hrs after LPS inhalation
12-lead ECG
Measured: Screening Visit 1 and final Visit 5
Physical exam
A complete physical exam at screening and at the final Visits, and an abbreviated physical exam at the three Visits during which LPS will be administered
Measured: At the Screening Visit 1, at the three Visits with LPS inhalation and at the Final Visit
Safety labs from peripheral blood
hematology, blood chemistry (ionogram, AST, ALT, alkaline phosphatases, urea, creatinine)
Measured: At the Screening Visit 1 and the Final Visit 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Brugmann
- Sponsor type
- University, hospital or other
- Investigators
- Olivier MICHEL, MD, PhD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081392
- Sponsor's protocol ID
- CIA-01.2
- Status last verified
- Mar 2010
- First submitted
- 2 Mar 2010
- Last updated
- 5 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Doyen V, Pilcer G, Dinh PH, Corazza F, Bernard A, Bergmann P, Lefevre N, Amighi K, Michel O. Inflammation induced by inhaled lipopolysaccharide depends on particle size in healthy volunteers. Br J Clin Pharmacol. 2016 Nov;82(5):1371-1381. doi: 10.1111/bcp.13052. Epub 2016 Jul 28.
PubMed 27331367
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Inhaled Particle Size on the Inflammatory Response Induced by Endotoxin Inhalation
- ClinicalTrials.gov ID
- NCT01081392
- Acronym / sponsor ID
- CIA-01.2
- Conditions
- Inflammation
- Keywords
- LPS, endotoxin, inflammatory markers, healthy volunteers, neutrophils in sputum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire BrugmannUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 5 Mar 2010 (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 the study is to measure inflammatory biomarkers in sputum and peripheral blood in healthy volunteers after inhalation of single doses of LPS (20 mcg) administered as particles of different sizes.
Detailed description
Endotoxins are inflammatory substances present in the environment. In man, the inhalation of the lipopolysaccharride moiety (LPS) induces measurable immune responses. With an inhaled single dose of 20 micron, the inflammatory response in man is sub-clinical. During bronchoprovocation tests with allergens, the particle size determines to a large extent the intensity of the response. the response to LPS as a function of particle size is not known and will be studied in this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LPS sequence 1 | Experimental | Biological: LPSNebulizers A then B then C |
| LPS sequence 2 | Experimental | Biological: LPSNebulizers B then C then A |
| LPS sequence 3 | Experimental | Biological: LPSNebulizers C then A then B |
| LPS sequence 4 | Experimental | Biological: LPSNebulizers A then C then B |
| LPS sequence 5 | Experimental | Biological: LPSNebulizers C then B then A |
| LPS sequence 6 | Experimental | Biological: LPSNebulizers B then A then C |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- healthy volunteer, non-smoking or ex-smoker >1mth and <10packs/year
- normal ECG
- normal lab values for hematology, ionogram, AST, ALT, alk phosphatases, urea, creatinine and CRP
- FEV1/forced vital capacity >0.7 and FEV1>80% of predicted value
- able to produce valid sputum following induction (>=50% viable cells, <50% squamous cells and <60% neutrophils)
Key exclusion criteria (3 listed)
- infection within 14 days
- history of bronchial asthma
- obstructive respiratory condition with FEV1 <70% of theoretical value
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 |
|---|---|---|
| LPSLPS 20mcg sd inhaled via nebulizer, 3 periods | Biological | LPS sequence 1, LPS sequence 2, LPS sequence 3, LPS sequence 4, LPS sequence 5, LPS sequence 6 |
Primary outcome
Absolute neutrophil count in sputum
Time frame: 24hrs after LPS inhalation
9 secondary outcomes
white blood cells and differential in peripheral blood
Time frame: 0, 6 and 24 hrs after LPS inhalation
CC16 in peripheral blood
Time frame: 0, 6 and 24hrs after LPS inhalation
Calgranulin A/B
Time frame: 0, 6 and 24hrs after LPS inhalation
CRP in peripheral blood
Time frame: 0, 6 and 24hrs after LPS inhalation
Spirometry (FEV1 and FEV1/FEV)
Time frame: 0, 1, 6 and 24hrs after LPS inhalation
Alveolo-capillary diffusion
Time frame: 0, 6 and 24hrs after LPS inhalation
12-lead ECG
Time frame: Screening Visit 1 and final Visit 5
Physical exam
Time frame: At the Screening Visit 1, at the three Visits with LPS inhalation and at the Final Visit
Safety labs from peripheral blood
Time frame: At the Screening Visit 1 and the Final Visit 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2010.
- Derived from this study: PubMed 27331367Doyen V, Pilcer G, Dinh PH, Corazza F, Bernard A, Bergmann P, Lefevre N, Amighi K, Michel O. Inflammation induced by inhaled lipopolysaccharide depends on particle size in healthy volunteers. Br J Clin Pharmacol. 2016 Nov;82(5):1371-1381. doi: 10.1111/bcp.13052. Epub 2016 Jul 28.
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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.
Olivier MICHEL, MD, PhD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LPS in people with Inflammation, run by Centre Hospitalier Universitaire Brugmann at 1 site in Belgium.
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 7 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 5 Mar 2010. 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 Belgium. 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. 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?
Results are not available in the source record.
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?
Absolute neutrophil count in sputum (time frame: 24hrs after LPS inhalation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01081392, which also lists 1 linked publication.
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 5 Mar 2010.