A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma
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ClinicalTrials.gov Identifier: NCT00252135 |
Recruitment Status :
Completed
First Posted : November 11, 2005
Last Update Posted : May 12, 2017
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Condition or disease |
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Asthma |
Study Type : | Observational |
Actual Enrollment : | 8023 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | An Epidemiologic Study of Xolair (Omalizumab): Evaluating Clinical Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma (EXCELS) |
Actual Study Start Date : | June 2004 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | November 2011 |

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Signed informed consent document (in the case of a minor, consent must be given by the child's parent or legally authorized representative)
- ≥12 years of age
- Physician diagnosis of moderate to severe persistent asthma
- Evidence or history of positive skin test or in vitro reactivity to an aeroallergen
- Willingness to participate fully for the duration of the study (5 years)
- For patients in the Xolair-treated cohort, have received at least one dose of Xolair therapy at the time of enrollment
Exclusion Criteria:
- Contraindication to Xolair therapy (e.g., patients who experienced a severe hypersensitivity reaction to Xolair)
- Acute asthma exacerbation within the previous 2 weeks of screening requiring any of the following: initiation of systemic corticosteroids, increased doses of systemic corticosteroids from baseline, doubling of inhaled corticosteroids, emergency room visit, or hospitalization
- Acute flare of significant systemic disease (e.g., infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of their disease within the previous 2 months
- Use of an experimental drug within 30 days prior to study screening
- Diagnosis of cystic fibrosis
- For patients in the non-Xolair-treated cohort, any prior treatment with Xolair

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252135
Study Director: | Dennis Wong, M.D. | Genentech, Inc. |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT00252135 |
Other Study ID Numbers: |
Q2948g |
First Posted: | November 11, 2005 Key Record Dates |
Last Update Posted: | May 12, 2017 |
Last Verified: | May 2017 |
Moderate to severe asthma |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |