Mild Allergic RhinitisPhase 1NCT00630461
Safety Study of 20,000 EU of Clinical Center Reference Endotoxin in Allergic Adults With and Without Mild Asthma
A Phase 1 study testing Clinical Center Reference Endotoxin in people with Mild Allergic Rhinitis and Mild Allergic Rhinitis With Mild Asthma, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of different workplaces, and is even found in homes. The endotoxin used for this study is obtained from the National Institutes of Health, and is called "Clinical Center Reference Endotoxin", or CCRE. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Mild Allergic Rhinitis, Mild Allergic Rhinitis With Mild Asthma
- What is being tested?
- Clinical Center Reference Endotoxin
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to May 2012
- Phase
- Phase 1
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Mild allergic rhinitis
- Mild allergic asthma
- Normal lung function
- No other chronic illness
Who cannot join
- Use of inhaled or oral steroids
- Emergency treatment of asthma in last year
- Inhaled tobacco use
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, 27599
About this study
Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of different workplaces, and is even found in homes. The endotoxin used for this study is obtained from the National Institutes of Health, and is called "Clinical Center Reference Endotoxin", or CCRE. The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in your sputum cell samples that the scientists can measure. Phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation. Eventually, with these types of studies we will be able to examine why some people are more sensitive to endotoxin. Scientists at other universities have found that while most people do not have a considerable lung response to endotoxin at doses as high as 60,000 EU (endotoxin units), a few respond to as little as a total dose of 4500 EU. Our study is designed to identify if using a dose of 20,000 EU causes changes in the lung cells but does not cause symptoms in our study subjects. In our previous studies in our lab, using an endotoxin from another source, we have used higher doses (15,000 EUs) in subjects with asthma with no major problems, and we have used 10,000 EUs of CCRE in subjects with allergies and asthma without problems. We have used 20,000 EUs of CCRE in healthy individuals with no major problems.
- Being tested
- Clinical Center Reference Endotoxin
- Keywords
- mild asthma, mild allergies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Center Reference EndotoxinBiological
single inhalation challenge
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased sputum neutrophils with no adverse events
Measured: 6 hours post challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Data collected under different protocol; funding exhuasted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, David B. Peden, MD, University of North Carolina, Chapel Hill
- Investigators
- David b Peden, MD, MS, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630461
- Sponsor's protocol ID
- 07-2026 GCRC 2627
- Status last verified
- Oct 2012
- First submitted
- 28 Feb 2008
- Last updated
- 8 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of 20,000 EU of Clinical Center Reference Endotoxin in Allergic Adults With and Without Mild Asthma
- ClinicalTrials.gov ID
- NCT00630461
- Acronym / sponsor ID
- 07-2026 GCRC 2627
- Keywords
- mild asthma, mild allergies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data collected under different protocol; funding exhuasted
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- May 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Mar 2008 (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.
Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of different workplaces, and is even found in homes. The endotoxin used for this study is obtained from the National Institutes of Health, and is called "Clinical Center Reference Endotoxin", or CCRE. The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in your sputum cell samples that the scientists can measure. Phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation. Eventually, with these types of studies we will be able to examine why some people are more sensitive to endotoxin. Scientists at other universities have found that while most people do not have a considerable lung response to endotoxin at doses as high as 60,000 EU (endotoxin units), a few respond to as little as a total dose of 4500 EU. Our study is designed to identify if using a dose of 20,000 EU causes changes in the lung cells but does not cause symptoms in our study subjects. In our previous studies in our lab, using an endotoxin from another source, we have used higher doses (15,000 EUs) in subjects with asthma with no major problems, and we have used 10,000 EUs of CCRE in subjects with allergies and asthma without problems. We have used 20,000 EUs of CCRE in healthy individuals with no major problems.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mild allergic rhinitis
- Mild allergic asthma
- Normal lung function
- No other chronic illness
Key exclusion criteria (3 listed)
- Use of inhaled or oral steroids
- Emergency treatment of asthma in last year
- Inhaled tobacco use
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 |
|---|---|---|
| Clinical Center Reference Endotoxinsingle inhalation challenge | Biological | – |
Primary outcome
Increased sputum neutrophils with no adverse events
Time frame: 6 hours post challenge
Results and safety
The study was stopped early (reason given: Data collected under different protocol; funding exhuasted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
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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.
David b Peden, MD, MS principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clinical Center Reference Endotoxin in people with Mild Allergic Rhinitis and Mild Allergic Rhinitis With Mild Asthma, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 8 Oct 2012. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Data collected under different protocol; funding exhuasted). 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?
Increased sputum neutrophils with no adverse events (time frame: 6 hours post challenge). 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 8 Oct 2012.