"EXCELS"-Epidemiologic study of Xolair (OMALIZUMAB)
| Possible benefit: | Control of asthma |
| Purpose of trial: | To evaluate the effectiveness & long-term safety in patients with moderate-severe asthma |
| Drug/Device being tested: | Xolair (Omalizumab) |
| Sponsoring Department: | Internal Medicine, Division of Pulmonary Medicine |
| SIU Faculty Physician: | Joseph Henkle, MD |
| Sponsoring Company: | Genentech, Inc |
| Ending date of study: | 2009 |
| SCRIHS Protocol Number: | 04-065 |
| Number of other sites in trial: | 500 |
| Type of patients needed: | Diagnosis of moderate to severe persistent asthma; evidence of positive skin test or in vitro reactivity to an aeroallergan Exclusions. Exclusions: Severe hypersensitivity to Xolair therapy; acute asthma exacerbation within 2 weeks of screening; acute flare of significant systemic disease within 2 months; use of an experimental drug within 30 days prior to study screening. |
| Age: | 12 years of age and older |
| Health status: | Moderate to severe asthma |
| Number of visits required: | Approximately 12 visits |
| Length of study involvement: | 5 years |
| Tests to be performed: | Blood sample for IgE level, physical exam, spirometry for lung function |
| Contact Person: | Diane Drew, R.N., CRC |
| Phone: | 217-545-9289 |
| E-Mail: | ddrew@siumed.edu |