InflammationBD100BronchoNCT02690571
Pulmonary Effects of 100% Biodiesel Exhaust
A study testing Bronchoscopy in people with Inflammation, run by Umeå University.
Trial summary
Air pollution is a global environmental and health concern, contributing to onset and deterioration of respiratory and cardiovascular diseases. As climate change and dependence on diminishing fossil fuel supplies have taken center stage in political and scientific debates, renewable carbon-neutral fuels like biodiesel… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Bronchoscopy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Apr 2014
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal ECG
- Normal Lung function
- Normal Blood samples
Who cannot join
- Smoking
- Pre-existing metabolomic, respiratory and cardiovascular disease
- Exposure to high levels of pollutants in occupation
About this study
Air pollution is a global environmental and health concern, contributing to onset and deterioration of respiratory and cardiovascular diseases. As climate change and dependence on diminishing fossil fuel supplies have taken center stage in political and scientific debates, renewable carbon-neutral fuels like biodiesel receive increasing attention. The most common biodiesel within the European Union, rapeseed oil methyl ester (RME) is perceived to be a "green fuel", as it is sustainable and of biological origin, and therefore is often predicted to be less harmful to human health. Whilst replacing petrodiesel with biodiesel may have advantageous ecological impacts, consequences to respiratory health remained largely unexplored.
The purpose of the current study is to evaluate whether inhalation of 100% RME biodiesel exhaust would result in an acute airway inflammatory response in healthy human subjects, as shown previously following exposure to petrodiesel exhaust.
- Conditions
- Inflammation
- Being tested
- Bronchoscopy
- Keywords
- Air Pollution, Biodiesel exhaust, Bronchoscopy, Metabolomics
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyOther
The bronchoscopy procedure was performed six hours after completion of the exposure session, with sampling of endobronchial mucosal biopsies, bronchial wash and bronchoalveolar lavage performed under topical anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Filtered air exposure | Sham comparator | One hour exposure to filtered air during intermittent exercise in controlled chamber, 6 hours after exposure bronchoscopy is performed. Receives: Other: Bronchoscopy |
| Biodiesel exhaust exposure | Experimental | One hour exposure to biodiesel exhaust (generated at same running conditions as earlier studies with diesel exhaust at approximate particle matter concentration 300 mcg/m3) during intermittent exercise in controlled chamber. Six hours after exposure bronchoscopy is performed. Receives: Other: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokines in Bronchial wash (BW)
Bronchial wash (BW) collected by bronchoscopy will be analyzed for cytokines (%).
Measured: 6 hours
Cell counts in Bronchial Wash
Bronchial wash (BW) collected by bronchoscopy will be analyzed for inflammatory cell counts (cells/ml).
Measured: 6 hours
Secondary outcomes (3)
Oxylipin Metabolomic profiling
Metabolomic testing done with mass spectrometry on blood samples, BW and BAL.
Measured: Baseline, 2 hours, 6 hours, 24 hours
Inflammation in bronchoalveolar lavage (BAL)
BAL collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/ml).
Measured: 6 hour
Inflammation in endomucosal biopsies
Biopsies collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/mm2).
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Bosson, Umeå University
- Investigators
- Jenny A Bosson, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690571
- Sponsor's protocol ID
- 184-31M
- Acronym
- BD100Broncho
- Status last verified
- Mar 2016
- First submitted
- 9 Feb 2016
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Effects of 100% Biodiesel Exhaust
- ClinicalTrials.gov ID
- NCT02690571
- Acronym / sponsor ID
- BD100Broncho / 184-31M
- Conditions
- Inflammation
- Keywords
- Air Pollution, Biodiesel exhaust, Bronchoscopy, Metabolomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Feb 2016 (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.
Air pollution is a global environmental and health concern, contributing to onset and deterioration of respiratory and cardiovascular diseases. As climate change and dependence on diminishing fossil fuel supplies have taken center stage in political and scientific debates, renewable carbon-neutral fuels like biodiesel receive increasing attention. The most common biodiesel within the European Union, rapeseed oil methyl ester (RME) is perceived to be a "green fuel", as it is sustainable and of biological origin, and therefore is often predicted to be less harmful to human health. Whilst replacing petrodiesel with biodiesel may have advantageous ecological impacts, consequences to respiratory health remained largely unexplored.
The purpose of the current study is to evaluate whether inhalation of 100% RME biodiesel exhaust would result in an acute airway inflammatory response in healthy human subjects, as shown previously following exposure to petrodiesel exhaust.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filtered air exposure | Sham comparator | Other: BronchoscopyOne hour exposure to filtered air during intermittent exercise in controlled chamber, 6 hours after exposure bronchoscopy is performed. |
| Biodiesel exhaust exposure | Experimental | Other: BronchoscopyOne hour exposure to biodiesel exhaust (generated at same running conditions as earlier studies with diesel exhaust at approximate particle matter concentration 300 mcg/m3) during intermittent exercise in controlled chamber. Six hours after exposure bronchoscopy is performed. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal ECG
- Normal Lung function
- Normal Blood samples
Key exclusion criteria (3 listed)
- Smoking
- Pre-existing metabolomic, respiratory and cardiovascular disease
- Exposure to high levels of pollutants in occupation
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 |
|---|---|---|
| BronchoscopyThe bronchoscopy procedure was performed six hours after completion of the exposure session, with sampling of endobronchial mucosal biopsies, bronchial wash and bronchoalveolar lavage performed under topical anaesthesia. | Other | Biodiesel exhaust exposure, Filtered air exposure |
Primary outcome
Cytokines in Bronchial wash (BW)
Time frame: 6 hours
Bronchial wash (BW) collected by bronchoscopy will be analyzed for cytokines (%).
Cell counts in Bronchial Wash
Time frame: 6 hours
Bronchial wash (BW) collected by bronchoscopy will be analyzed for inflammatory cell counts (cells/ml).
3 secondary outcomes
Oxylipin Metabolomic profiling
Time frame: Baseline, 2 hours, 6 hours, 24 hours
Inflammation in bronchoalveolar lavage (BAL)
Time frame: 6 hour
Inflammation in endomucosal biopsies
Time frame: 6 hours
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 21 Mar 2016.
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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.
Jenny A Bosson, MD, PhD principal investigator
Umeå University
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy in people with Inflammation, run by Umeå University.
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 3 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: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Cytokines in Bronchial wash (BW) (time frame: 6 hours). The study lists 2 primary outcomes in all. 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 21 Mar 2016.