AsthmaPhase 4NCT00657891
The Effect of Xolair (Omalizumab) on Allergy Blood Cells
A Phase 4 study testing Omalizumab in people with Asthma, run by Creighton University at 1 site in United States.
Trial summary
We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Oct 2007
- Phase
- Phase 4
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 2 year history of ragweed allergic rhinitis
- positive skin prick tests to ragweed >5 mm wheal diameter
- serum IgE <700 iU/m
Who cannot join
- Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 1 week
- History of immunotherapy in the past 2 years
- Exposure to Omalizumab in the past 2 years
- Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens
- Asthma other than mild intermittent
- Women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding
Show all 10Show fewer
- Known sensitivity to study drug Xolair
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Patients with a previous history of cancer
- Use of any other investigational agent in the last 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Medical Center
Omaha, Nebraska, 68131
About this study
Official title: The Effect of Xolair (Omalizumab) on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic.
Read the detailed description
Must be allergic-asthma with IgE between 30 and 700 IU/ml.
- Conditions
- Asthma
- Being tested
- Omalizumab, Placebo
- Keywords
- Allergic Asthma, Anti IgE, Xolair, Basophil, IL-13, IL-4, Histamine
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called Xolair, rhumabe35
0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously
PlaceboDrug
Placebo Injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Injection Receives: Drug: Placebo |
| 2 | Experimental | Xolair at 0.016 mg/kg/IgE(iu/ml)/4 wks Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if Xolair (omalizumab) inhibits basophil leukotriene secretion & to compare this with its inhibition of histamine release. We will also compare this inhibition in basophils stimulated with allergen vs anti-IgE vs calcium ionophore.
Measured: 1 year
Secondary outcomes (1)
To determine the effect of Xolair (omalizumab) on IL-4 &vIL-13 secretion. To compare the effect of Xolair on IL-4 vs IL-13 secretion from basophils stimulated with allergen, anti-IgE & calcium ionophore (ionomycin).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMar 2007
- Primary completionOct 2007
- Study completionOct 2007
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.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Robert G Townley, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657891
- Sponsor's protocol ID
- IgE 025 US22
- Status last verified
- Sep 2013
- First submitted
- 8 Apr 2008
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Xolair (Omalizumab) on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
- ClinicalTrials.gov ID
- NCT00657891
- Acronym / sponsor ID
- IgE 025 US22
- Conditions
- Asthma
- Keywords
- Allergic Asthma, Anti IgE, Xolair, Basophil, IL-13, IL-4, Histamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Mar 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 14 Apr 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.
We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic.
Detailed description
Must be allergic-asthma with IgE between 30 and 700 IU/ml.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo Injection |
| 2 | Experimental | Drug: OmalizumabXolair at 0.016 mg/kg/IgE(iu/ml)/4 wks |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 2 year history of ragweed allergic rhinitis
- positive skin prick tests to ragweed >5 mm wheal diameter
- serum IgE <700 iU/m
Key exclusion criteria (10 listed)
- Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 1 week
- History of immunotherapy in the past 2 years
- Exposure to Omalizumab in the past 2 years
- Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens
- Asthma other than mild intermittent
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: Xolair, rhumabe350.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously | Drug | 2 |
| PlaceboPlacebo Injection | Drug | 1 |
Primary outcome
To determine if Xolair (omalizumab) inhibits basophil leukotriene secretion & to compare this with its inhibition of histamine release. We will also compare this inhibition in basophils stimulated with allergen vs anti-IgE vs calcium ionophore.
Time frame: 1 year
1 secondary outcome
To determine the effect of Xolair (omalizumab) on IL-4 &vIL-13 secretion. To compare the effect of Xolair on IL-4 vs IL-13 secretion from basophils stimulated with allergen, anti-IgE & calcium ionophore (ionomycin).
Time frame: 1 year
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 1 Oct 2013.
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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.
Robert G Townley, MD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omalizumab in people with Asthma, run by Creighton University 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 3 inclusion and 10 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 1 Oct 2013. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To determine if Xolair (omalizumab) inhibits basophil leukotriene secretion & to compare this with its inhibition of histamine release. We will also compare this inhibition in basophils stimulated with allergen vs anti-IgE vs calcium ionophore. (time frame: 1 year). 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 1 Oct 2013.