Xolair in Patients With Chronic Sinusitis
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- University of Chicago
- Study ID
- NCT00117611
- Phase
- PHASE4
- Status
- Completed
Conditions
- Sinusitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Anti-IgE antibody omalizumab or placebo — DRUGgiven subcutaneously oce or twice monthly depending on dose
Study Details
The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.
Key Dates
- Start date
- Jul 31, 2005
- Status verified
- Sep 2013
- Primary completion
- May 31, 2007
- Completion
- Jan 31, 2009
Study Design
- Enrollment
- 14 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: 1Xolair administered subcutaneously, once or twice monthly (dose dependent on subject weight and serum IgE level)
- Placebo Comparator: 2placebo administered subcutaneously once or twice monthly
Primary Outcome Measure
Mucosal thickness on CT scan [ Time Frame: after 6 months of treatment ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | - |
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