AsthmaNCT00287378
Effect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab
A study testing omalizumab in people with Asthma and Allergy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Ozone can cause acute airway inflammation in both asthmatics and normal volunteers. However, in asthmatics ozone can cause episodes of worsening of asthma. We want to learn if chronic allergic response, known as "IgE-induced airway inflammation" is what causes the increased inflammation in response to ozone. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- What is being tested?
- omalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jul 2007
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Normal lung function, defined as (Knudson 1976/1984 predicted set):
- FVC of > 80 % of that predicted for gender, ethnicity, age and height
- FEV1 of > 80 % of that predicted for gender, ethnicity, age and height
- FEV1/FVC ratio of > 80 % of predicted values
- Evidence of allergy to house dust mite
- Oxygen saturation of > 94 %
Show all 9Show fewer
- Normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg)
- Symptom Score (defined in section "f") no greater than 20 (out of a possible 60) for total symptom score with a value no greater than 3 for any one score. No more than one score may be greater or equal than 3.
- IgE within the following ranges and body weights for omalizumab dosing: IgE ≥30-700 int. units/mL, and weight 30-90 kg.
Who cannot join
- A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma, hypertension)
- Allergy to any medications which may be used in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids, lactose, polyethylene glycol)
- Positive pregnancy test at time of initial screening
- Medications which may impact the results of the ozone challenge, interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics)
- Mega doses of vitamins and supplements, homeopathic/naturopathic medicines
- Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 2 weeks. Documentation of normal lung function (as defined in "Specific Inclusion Criteria") must be met.
Show all 17Show fewer
- Unspecified illnesses, which in the judgment of the investigator increase the risk associated with ozone inhalation challenge, will be a basis for exclusion.
- Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months.
- Use of systemic steroid therapy within the preceding 12 months.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Environmental Medicine, Asthma and Lung Biology at the University of North Carolina
Chapel Hill, North Carolina, 27599-7310
About this study
Ozone can cause acute airway inflammation in both asthmatics and normal volunteers. However, in asthmatics ozone can cause episodes of worsening of asthma. We want to learn if chronic allergic response, known as "IgE-induced airway inflammation" is what causes the increased inflammation in response to ozone. To do this we will examine the response to ozone in a group of asthmatics treated with omalizumab, a medicine available and approved for use in people with asthma, or a placebo control. The placebo for this study is inert physiologic saline ("salt water") which contains no omalizumab. Both the omalizumab and the placebo will be administered as an injection under the skin. Omalizumab, also called Xolair, is a humanized monoclonal antibody, which means that it originally was produced in mice, then genetically engineered to look more like human than mouse antibody. Omalizumab inactivates IgE, a protein our own immune systems make as part of allergic reactions. The purpose of this study is to test the hypothesis that omalizumab, by blocking this aspect of allergic reactions, will decrease the number of inflammatory cells in the airway after ozone challenge. We also hypothesize that omalizumab will decrease the effects of ozone on changes in lung function, mucociliary clearance (a measure of how quickly mucus clears form the airway) and airway reactivity. Airway reactivity is a measure of how sensitive the airways are to a medication used to diagnose asthma, called methacholine. We will examine these as additional information we can learn during the course of the study. This is a blinded study, meaning that neither you nor the researchers know if you get the active drug or placebo, but that information can be obtained if needed. The placebo is an injection of inert physiological saline ("salt water") which contains no omalizumab.
Read the detailed description
Week 0: Training and baseline studies day MCC (Dr. Bennett and MCC technician); blood draw for baseline studies, urine pregnancy test if applicable, treadmill training, spirometry, exercise testing with minute ventilation measurement, and sputum induction for baseline studies (SC)
Randomization of cohorts for study (SC):
- Mild, mite sensitive asthmatics randomized to omalizumab
- Mild mite sensitive asthmatics on placebo
Week 1: Visit for injection of omalizumab vs. placebo (injections carried out by CEMALB nurse; MD immediately available in facility) (see below for dosing of omalizumab); phlebotomy for baseline CBC with platelets; urine pregnancy test if applicable
Week 3: Visit for injection of omalizumab vs. placebo; urine pregnancy test if applicable
Week 5: Visit for injection of omalizumab vs. placebo (CEMALB nurse); urine pregnancy test if applicable
Week 7: Visit for injection of omalizumab vs. placebo; urine pregnancy test if applicable
Week 9: Visit for injection of omalizumab vs. placebo; urine pregnancy test if applicable
Week 11: Visit for injection of omalizumab vs. placebo, phlebotomy for CBC and platelets; urine pregnancy test if applicable
Randomization of chamber exposure order (for each cohort) (SC):
- Clean, filtered air with mild exercise for 2 hours
- 0.4 ppm O3 with mild exercise for 2 hours
Week 13: EXPOSURE PROCEDURES-SESSION 1
Day 1 (Pre-exposure):
- Review medical history (30 min) (SC)
- Pre-challenge spirometry (30 min) (SC)
- Sputum induction (SC) for assessment of pre-challenge differential cell counts, CD11b, cell identification markers, samples for mucus and mediator assessments (30 min)
- Phlebotomy for circulating cell surface markers, and for CBC and platelet count (30 min) (CEMALB nurse)
- urine pregnancy test if applicable
Day 2 (Exposure to Air or 0.4 ppm Ozone for 2 hours):
- Pre-challenge spirometry and symptom scoring (SC) and physical examination assessment (Investigator MD) (1 hr)
- Begin 2 hours morning exposure/exercise protocol (15 minutes of mild exercise followed by15 minutes rest for total of 2 hrs, spirometry and minute ventilation 2 minutes after beginning each exercise session) (SC and Human Studies Facility exposure chamber staff) (see below for dosing of ozone)
- Post-challenge spirometry and symptom scoring (SC)
- Inhalation of 99mTc labeled particles and baseline imaging for MCC and C/P ratio (30 minutes) (Dr Bennett and MCC technician)
- Gamma camera scintigraphy for assessment of MCC for 2 hours post inhalation (Dr Bennett and MCC technician). A lunch will be provided and subjects will have time to eat during part of this study day.
- Methacholine challenge for NSBR (1 hr) (SC)
- Administration of 2 puffs of albuterol
- Sputum induction for assessment of post-challenge cell differential counts, CD11b, cell identification markers, samples for mucus and mediator assessments (30 min) (SC)
- Phlebotomy for circulating cell surface markers (30 min) (CEMALB staff)
- Overnight observation in GCRC if needed (for observation or treatment for adverse event as defined below under Safety Measures). (CEMALB nurse and Investigator MD)
Day 3 (followup gamma scan)
- Return next morning for 30 min gamma camera scan. (Dr Bennett and MCC technician)
- Symptom scoring and dismiss home (SC), Physical assessment
THREE WEEK WAITING PERIOD (+/- 1 WEEK)
Week 16: EXPOSURE PROCEDURES-SESSION 2
Similar to Session 1 except with opposite (air or ozone) exposure regimen.
Study Discontinuation Visit (5-10 days after last exposure) History, spirometry (SC), medical evaluation if needed (Investigator MD)
Dosages of ozone and omalizumab
Ozone:The 0.4 ppm ozone exposures will be conducted in an ozone exposure chamber. Each subject will be exposed to ozone for 2 hours. During exposures, subjects will perform four 15 minute bouts of moderate exercise (minute ventilation or VE = 30 40 L/min) on a treadmill, each separated by 15 minutes of seated rest. Minute ventilation is measured for 2-3 minutes after about 4 minutes of exercise during the first exercise period, and again at about 12 minutes of exercise. It is then measured at about 12 minutes into each exercise period.
Omalizumab: Dosing for omalizumab will be consistent with doses approved for use in moderate or severe allergic asthma. The only exception to its indicated use is that we will be examining its effect in mild (rather than moderate or severe) allergic asthmatics, a group we have recruited for ozone challenge. IgE within the following ranges and body weights for subcutaneous omalizumab dosing:
- IgE ≥30-100 int. units/mL: 30-90 kg: 150 mg every 4 weeks
- IgE >100-200 int. units/mL: 30-90 kg: 300 mg every 4 weeks
- IgE >200-300 int. units/mL:30-60 kg: 300 mg every 4 weeks >60-90 kg: 225 mg every 2 weeks
- IgE >300-400 int. units/mL:30-70 kg: 225 mg every 2 weeks>70-90 kg: 300 mg every 2 weeks
- IgE >400-500 int. units/mL:30-70 kg: 300 mg every 2 weeks>70-90 kg: 375 mg every 2 weeks
- IgE >500-600 int. units/mL:30-60 kg: 300 mg every 2 weeks>60-70 kg: 375 mg every 2 weeks>70 kg: Do not administer dose
- IgE >600-700 int. units/mL:30-60 kg: 375 mg every 2 weeks
Subjects for whom the IgE level and weight indicate that no dose will be given will be excluded from the study.
- Being tested
- omalizumab
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumabDrug
Also called Xolair
omalizumab as per weight and IgE
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint (increase in airway neutrophils) will be assessed by comparison of the differences between sputum neutrophil influx after ozone (adjusted for post air challenge neutrophils) between omalizumab and placebo treated volunteers
Measured: 16 weeks
Secondary outcomes (3)
Differences in ozone induced changes in FEV1 and FVC between omalizumab and control groups
Measured: 16 weeks
Differences in mucociliary clearance and airway deposition between omalizumab and control groups
Measured: 16 weeks
Differences in ozone induced changes in sputum eosinophils between omalizumab and control groups
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2007
- Study completionJul 2007
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 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), Genentech, Inc.
- Investigators
- Terry L Noah, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287378
- Sponsor's protocol ID
- GCRC-2423
- Other IDs
- HL080337-01
- Status last verified
- Feb 2009
- First submitted
- 3 Feb 2006
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab
- ClinicalTrials.gov ID
- NCT00287378
- Acronym / sponsor ID
- GCRC-2423
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Genentech, Inc.
- Study start
- Mar 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 6 Feb 2006 (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.
Ozone can cause acute airway inflammation in both asthmatics and normal volunteers. However, in asthmatics ozone can cause episodes of worsening of asthma. We want to learn if chronic allergic response, known as "IgE-induced airway inflammation" is what causes the increased inflammation in response to ozone. To do this we will examine the response to ozone in a group of asthmatics treated with omalizumab, a medicine available and approved for use in people with asthma, or a placebo control. The placebo for this study is inert physiologic saline ("salt water") which contains no omalizumab. Both the omalizumab and the placebo will be administered as an injection under the skin. Omalizumab, also called Xolair, is a humanized monoclonal antibody, which means that it originally was produced in mice, then genetically engineered to look more like human than mouse antibody. Omalizumab inactivates IgE, a protein our own immune systems make as part of allergic reactions. The purpose of this study is to test the hypothesis that omalizumab, by blocking this aspect of allergic reactions, will decrease the number of inflammatory cells in the airway after ozone challenge. We also hypothesize that omalizumab will decrease the effects of ozone on changes in lung function, mucociliary clearance (a measure of how quickly mucus clears form the airway) and airway reactivity. Airway reactivity is a measure of how sensitive the airways are to a medication used to diagnose asthma, called methacholine. We will examine these as additional information we can learn during the course of the study. This is a blinded study, meaning that neither you nor the researchers know if you get the active drug or placebo, but that information can be obtained if needed. The placebo is an injection of inert physiological saline ("salt water") which contains no omalizumab.
Detailed description
Week 0: Training and baseline studies day MCC (Dr. Bennett and MCC technician); blood draw for baseline studies, urine pregnancy test if applicable, treadmill training, spirometry, exercise testing with minute ventilation measurement, and sputum induction for baseline studies (SC)
Randomization of cohorts for study (SC):
- Mild, mite sensitive asthmatics randomized to omalizumab
- Mild mite sensitive asthmatics on placebo
Week 1: Visit for injection of omalizumab vs. placebo (injections carried out by CEMALB nurse; MD immediately available in facility) (see below for dosing of omalizumab); phlebotomy for baseline CBC with platelets; urine pregnancy test if applicable
Week 3: Visit for injection of omalizumab vs. placebo; urine pregnancy test if applicable
Week 5: Visit for injection of omalizumab vs. placebo (CEMALB nurse); urine pregnancy test if applicable
Week 7: Visit for injection of omalizumab vs. placebo; urine pregnancy test if applicable
Week 9: Visit for injection of omalizumab vs. placebo; urine pregnancy test if applicable
Week 11: Visit for injection of omalizumab vs. placebo, phlebotomy for CBC and platelets; urine pregnancy test if applicable
Randomization of chamber exposure order (for each cohort) (SC):
- Clean, filtered air with mild exercise for 2 hours
- 0.4 ppm O3 with mild exercise for 2 hours
Week 13: EXPOSURE PROCEDURES-SESSION 1
Day 1 (Pre-exposure):
- Review medical history (30 min) (SC)
- Pre-challenge spirometry (30 min) (SC)
- Sputum induction (SC) for assessment of pre-challenge differential cell counts, CD11b, cell identification markers, samples for mucus and mediator assessments (30 min)
- Phlebotomy for circulating cell surface markers, and for CBC and platelet count (30 min) (CEMALB nurse)
- urine pregnancy test if applicable
Day 2 (Exposure to Air or 0.4 ppm Ozone for 2 hours):
- Pre-challenge spirometry and symptom scoring (SC) and physical examination assessment (Investigator MD) (1 hr)
- Begin 2 hours morning exposure/exercise protocol (15 minutes of mild exercise followed by15 minutes rest for total of 2 hrs, spirometry and minute ventilation 2 minutes after beginning each exercise session) (SC and Human Studies Facility exposure chamber staff) (see below for dosing of ozone)
- Post-challenge spirometry and symptom scoring (SC)
- Inhalation of 99mTc labeled particles and baseline imaging for MCC and C/P ratio (30 minutes) (Dr Bennett and MCC technician)
- Gamma camera scintigraphy for assessment of MCC for 2 hours post inhalation (Dr Bennett and MCC technician). A lunch will be provided and subjects will have time to eat during part of this study day.
- Methacholine challenge for NSBR (1 hr) (SC)
- Administration of 2 puffs of albuterol
- Sputum induction for assessment of post-challenge cell differential counts, CD11b, cell identification markers, samples for mucus and mediator assessments (30 min) (SC)
- Phlebotomy for circulating cell surface markers (30 min) (CEMALB staff)
- Overnight observation in GCRC if needed (for observation or treatment for adverse event as defined below under Safety Measures). (CEMALB nurse and Investigator MD)
Day 3 (followup gamma scan)
- Return next morning for 30 min gamma camera scan. (Dr Bennett and MCC technician)
- Symptom scoring and dismiss home (SC), Physical assessment
THREE WEEK WAITING PERIOD (+/- 1 WEEK)
Week 16: EXPOSURE PROCEDURES-SESSION 2
Similar to Session 1 except with opposite (air or ozone) exposure regimen.
Study Discontinuation Visit (5-10 days after last exposure) History, spirometry (SC), medical evaluation if needed (Investigator MD)
Dosages of ozone and omalizumab
Ozone:The 0.4 ppm ozone exposures will be conducted in an ozone exposure chamber. Each subject will be exposed to ozone for 2 hours. During exposures, subjects will perform four 15 minute bouts of moderate exercise (minute ventilation or VE = 30 40 L/min) on a treadmill, each separated by 15 minutes of seated rest. Minute ventilation is measured for 2-3 minutes after about 4 minutes of exercise during the first exercise period, and again at about 12 minutes of exercise. It is then measured at about 12 minutes into each exercise period.
Omalizumab: Dosing for omalizumab will be consistent with doses approved for use in moderate or severe allergic asthma. The only exception to its indicated use is that we will be examining its effect in mild (rather than moderate or severe) allergic asthmatics, a group we have recruited for ozone challenge. IgE within the following ranges and body weights for subcutaneous omalizumab dosing:
- IgE ≥30-100 int. units/mL: 30-90 kg: 150 mg every 4 weeks
- IgE >100-200 int. units/mL: 30-90 kg: 300 mg every 4 weeks
- IgE >200-300 int. units/mL:30-60 kg: 300 mg every 4 weeks >60-90 kg: 225 mg every 2 weeks
- IgE >300-400 int. units/mL:30-70 kg: 225 mg every 2 weeks>70-90 kg: 300 mg every 2 weeks
- IgE >400-500 int. units/mL:30-70 kg: 300 mg every 2 weeks>70-90 kg: 375 mg every 2 weeks
- IgE >500-600 int. units/mL:30-60 kg: 300 mg every 2 weeks>60-70 kg: 375 mg every 2 weeks>70 kg: Do not administer dose
- IgE >600-700 int. units/mL:30-60 kg: 375 mg every 2 weeks
Subjects for whom the IgE level and weight indicate that no dose will be given will be excluded from the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: omalizumab |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Normal lung function, defined as (Knudson 1976/1984 predicted set):
- FVC of > 80 % of that predicted for gender, ethnicity, age and height
- FEV1 of > 80 % of that predicted for gender, ethnicity, age and height
- FEV1/FVC ratio of > 80 % of predicted values
- Evidence of allergy to house dust mite
Key exclusion criteria (17 listed)
- A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma, hypertension)
- Allergy to any medications which may be used in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids, lactose, polyethylene glycol)
- Positive pregnancy test at time of initial screening
- Medications which may impact the results of the ozone challenge, interfere with any other medications potentially used in the study (to include steroids, beta antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics)
- Mega doses of vitamins and supplements, homeopathic/naturopathic medicines
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 |
|---|---|---|
| omalizumabAlso: Xolairomalizumab as per weight and IgE | Drug | 1 |
Primary outcome
The primary efficacy endpoint (increase in airway neutrophils) will be assessed by comparison of the differences between sputum neutrophil influx after ozone (adjusted for post air challenge neutrophils) between omalizumab and placebo treated volunteers
Time frame: 16 weeks
3 secondary outcomes
Differences in ozone induced changes in FEV1 and FVC between omalizumab and control groups
Time frame: 16 weeks
Differences in mucociliary clearance and airway deposition between omalizumab and control groups
Time frame: 16 weeks
Differences in ozone induced changes in sputum eosinophils between omalizumab and control groups
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2009.
- Center for Environmental Medicine, Asthma and Lung BiologyLink provided by the sponsor.
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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.
Terry L Noah, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omalizumab in people with Asthma and Allergy, 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 9 inclusion and 17 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 30 Jun 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.
Are results available for this study?
The study was stopped early (reason given: lack of enrollment). 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?
The primary efficacy endpoint (increase in airway neutrophils) will be assessed by comparison of the differences between sputum neutrophil influx after ozone (adjusted for post air challenge neutrophils) between omalizumab and placebo treated volunteers (time frame: 16 weeks). 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 30 Jun 2009.