CClinicalTrials.gg
Sign In
CompletedNCT00657891Updated Oct 1, 2013

The Effect of Xolair (Omalizumab) on Allergy Blood Cells

A Phase 4 interventional study of Omalizumab and Placebo in Asthma, sponsored by Creighton University. Completed at 1 site in United States. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-10-01.

Sponsored by Creighton University · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
16 Years to 50 Years
Sex
All
01

Study 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 the detailed description

Must be allergic-asthma with IgE between 30 and 700 IU/ml.

02

Conditions studied

  • Asthma

Browse trials for

Keywords

  • Allergic Asthma
  • Anti IgE
  • Xolair
  • Basophil
  • IL-13
  • IL-4
  • Histamine
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 49 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Creighton University is the lead sponsor of 126 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 2 year history of ragweed allergic rhinitis
  • positive skin prick tests to ragweed >5 mm wheal diameter
  • serum IgE \<700 iU/m

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
49 participants (actual)

Study arms

  • Placebo comparator
    1

    Placebo Injection

    Drug: Placebo

  • Experimental
    2

    Xolair at 0.016 mg/kg/IgE(iu/ml)/4 wks

    Drug: Omalizumab

Interventions

  • DrugOmalizumab

    0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously

    Also known as: Xolair, rhumabe35

  • DrugPlacebo

    Placebo Injection

06

What researchers measure

Primary outcomes

  1. 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

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).

    Time frame: 1 year

07

Study locations

1 site
  • Creighton University Medical Center
    Omaha, Nebraska 68131, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00657891
Lead sponsor
Creighton University
Collaborators
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 14, 2008
Start date
Mar 2007
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Oct 1, 2013

Study contacts

Robert G Townley, MD
principal investigator · Creighton University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Asthma→

Other studies from this sponsor

Creighton University

Start the discussion