Rhinitis, Allergic, PerennialPhase 1NCT00839189
Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults
A Phase 1 study testing Clinical Center Reference Endotoxin (CCRE) in people with Rhinitis, Allergic, Perennial and Rhinitis, Allergic, Seasonal, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purposes of this pilot safety study are to identify a dose of inhaled Clinical Center Reference Endotoxin (CCRE) that is well tolerated by allergic subjects that induces measurable increases in neutrophil content of induced sputum that can be employed to screen large populations for susceptibility to the… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Asthma
- What is being tested?
- Clinical Center Reference Endotoxin (CCRE)
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jun 2006
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Specific allergy to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response.
- FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .75 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma.
- History of nasal allergy, including episodic, perennial, or seasonal sneezing, nasal congestion or cough, or such symptoms associated with specific exposures (such as cat or dog)
- Criteria for classification as having asthma with allergic rhinitis vs. allergic rhinitis alone:
- History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma.
- Provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used (see below).
Who cannot join
- Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease.
- Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
- Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician.
- Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable.
- Use of daily theophylline within the past month.
- Pregnancy or nursing a baby.
Show all 13Show fewer
- Cigarette smoking > 1 pack per month.
- Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
- Exacerbation of asthma more than 2x/week which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma.
- Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise).
- Dosing level of an inhaled steroid must be consistent with mild episodic asthma as outlined by the NHLBI NAEPP guidelines. Any dose of inhaled steroid typically used for moderate or severe asthma will result in exclusion from the protocol.
- Viral upper respiratory tract infection within 2 weeks of challenge.
- Any acute infection requiring antibiotics within 2 weeks of challenge.
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, 27599-7310
About this study
Official title: Safety Study To Determine the Effect of a 10,000 EU Dose of Clinical Center Reference Endotoxin in Allergic and Mildly Asthmatic Adults
The purposes of this pilot safety study are to identify a dose of inhaled Clinical Center Reference Endotoxin (CCRE) that is well tolerated by allergic subjects that induces measurable increases in neutrophil content of induced sputum that can be employed to screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin.
Read the detailed description
Twenty-four or forty-eight hours (study day 1) prior to the inhalation challenge, subjects will undergo a physical examination of the ears, nose, throat and chest and will have an assessment of vital signs (temperature, pulse, respiratory rate, blood pressure), oxygen saturation, symptom score assessment and undergo spirometry to rule out acute illness prior to challenge. All female volunteers will undergo a urine pregnancy test. A similar examination will take place immediately prior to inhalation challenge with 10,000 EU of CCRE, as well as 30, 60, 120, 180, 240, 300 and 360 minutes and 24 hours after challenge (with the exception of a pregnancy test which will only be administered prior to sputum induction on study day 1). Induced sputum will be 24 to 48 hours prior to challenge, and again six hours after challenge on Study day 2. Sputum will be analyzed for PMN content, CD14 expression on airway macrophages and monocytes, soluble CD14 levels, cytokine levels in sputum and products of inflammatory cells (eosinophil, cationic protein, myeloperoxidase). Blood will be collected for a CBC and differential when the pre- challenge induced sputum is obtained and again 6 hours after challenge. Subjects will then be escorted to the GCRC for overnight admission. While on the GCRC, vital signs will be obtained every 2 hours till bedtime, then once a shift. Spirometry will not be obtained while the subject is in the GCRC, however the subject will be given symptom scoring cards. The next morning (study day 3) subjects will be discharged and escorted to the CEMALB for a final set of vital signs, spirometry, symptom scoring, and an examination by a study physician.
Each volunteer will be given a symptom scoring sheet for each day up to 96 hours (4 days) after challenge.
Each sheet will include the name and phone number of the study coordinator and study MD. Sample home symptom scoring sheets and instructions are included with this protocol.
Between 48 and 96 hours after challenge, each volunteer will be called to determine their status, inquiring about symptoms, symptom scoring, and need for medication and/or physician visits.
Between 7 and 10 days of the challenge dose, each subject will be asked to return for a study discontinuation visit. At that time temperature, pulse, systolic and diastolic BP, respiratory rate, FVC and FEV1 and SpO2 (oxygen saturation), and symptoms scores will be assessed and, if abnormal, medical evaluation as directed by the study physician will be undertaken.
- Being tested
- Clinical Center Reference Endotoxin (CCRE)
- Keywords
- CCRE, endotoxin, LPS, asthma, allergies, allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Asthma, Hypersensitivity, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Center Reference Endotoxin (CCRE)Biological
Also called LPS, endotoxin
Inhalation of 10,000 EU CCRE
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of change in neutrophil content of induced sputum after inhalation of 10,000 EU CCRE
Measured: 0-24 hours post challenge
Secondary outcomes (1)
change in PFT's, vital signs and symptom score after inhalation of 10,000 EU of CCRE
Measured: 0-24 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 posted9 Feb 2009 (estimated)
- Study startOct 2002
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Allergic, PerennialStudies 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- David Peden, MD, Principal investigator, University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839189
- Sponsor's protocol ID
- 02-1518 (GCRC 1983)
- Other IDs
- NIH HL080337
- Status last verified
- Dec 2009
- First submitted
- 6 Feb 2009
- Last updated
- 9 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study To Determine the Effect of a 10,000 EU Dose of Clinical Center Reference Endotoxin in Allergic and Mildly Asthmatic Adults
- ClinicalTrials.gov ID
- NCT00839189
- Acronym / sponsor ID
- 02-1518 (GCRC 1983)
- Keywords
- CCRE, endotoxin, LPS, asthma, allergies, allergic rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 9 Feb 2009 (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 purposes of this pilot safety study are to identify a dose of inhaled Clinical Center Reference Endotoxin (CCRE) that is well tolerated by allergic subjects that induces measurable increases in neutrophil content of induced sputum that can be employed to screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin.
Detailed description
Twenty-four or forty-eight hours (study day 1) prior to the inhalation challenge, subjects will undergo a physical examination of the ears, nose, throat and chest and will have an assessment of vital signs (temperature, pulse, respiratory rate, blood pressure), oxygen saturation, symptom score assessment and undergo spirometry to rule out acute illness prior to challenge. All female volunteers will undergo a urine pregnancy test. A similar examination will take place immediately prior to inhalation challenge with 10,000 EU of CCRE, as well as 30, 60, 120, 180, 240, 300 and 360 minutes and 24 hours after challenge (with the exception of a pregnancy test which will only be administered prior to sputum induction on study day 1). Induced sputum will be 24 to 48 hours prior to challenge, and again six hours after challenge on Study day 2. Sputum will be analyzed for PMN content, CD14 expression on airway macrophages and monocytes, soluble CD14 levels, cytokine levels in sputum and products of inflammatory cells (eosinophil, cationic protein, myeloperoxidase). Blood will be collected for a CBC and differential when the pre- challenge induced sputum is obtained and again 6 hours after challenge. Subjects will then be escorted to the GCRC for overnight admission. While on the GCRC, vital signs will be obtained every 2 hours till bedtime, then once a shift. Spirometry will not be obtained while the subject is in the GCRC, however the subject will be given symptom scoring cards. The next morning (study day 3) subjects will be discharged and escorted to the CEMALB for a final set of vital signs, spirometry, symptom scoring, and an examination by a study physician.
Each volunteer will be given a symptom scoring sheet for each day up to 96 hours (4 days) after challenge.
Each sheet will include the name and phone number of the study coordinator and study MD. Sample home symptom scoring sheets and instructions are included with this protocol.
Between 48 and 96 hours after challenge, each volunteer will be called to determine their status, inquiring about symptoms, symptom scoring, and need for medication and/or physician visits.
Between 7 and 10 days of the challenge dose, each subject will be asked to return for a study discontinuation visit. At that time temperature, pulse, systolic and diastolic BP, respiratory rate, FVC and FEV1 and SpO2 (oxygen saturation), and symptoms scores will be assessed and, if abnormal, medical evaluation as directed by the study physician will be undertaken.
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
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Specific allergy to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response.
- FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .75 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma.
- History of nasal allergy, including episodic, perennial, or seasonal sneezing, nasal congestion or cough, or such symptoms associated with specific exposures (such as cat or dog)
- Criteria for classification as having asthma with allergic rhinitis vs. allergic rhinitis alone:
- History of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician diagnosed asthma.
Key exclusion criteria (13 listed)
- Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease.
- Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
- Use of systemic steroid therapy within the preceding 12 months for an asthma exacerbation. All use of systemic steroids in the last year will be reviewed by a study physician.
- Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable.
- Use of daily theophylline within the past month.
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 Endotoxin (CCRE)Also: LPS, endotoxinInhalation of 10,000 EU CCRE | Biological | – |
Primary outcome
Magnitude of change in neutrophil content of induced sputum after inhalation of 10,000 EU CCRE
Time frame: 0-24 hours post challenge
1 secondary outcome
change in PFT's, vital signs and symptom score after inhalation of 10,000 EU of CCRE
Time frame: 0-24 hours post challenge
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 9 Dec 2009.
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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 Peden, MD principal investigator
University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology
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 (CCRE) in people with Rhinitis, Allergic, Perennial and Rhinitis, Allergic, Seasonal, 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 6 inclusion and 13 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 9 Dec 2009. 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 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?
Magnitude of change in neutrophil content of induced sputum after inhalation of 10,000 EU CCRE (time frame: 0-24 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 9 Dec 2009.