A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma
May 11, 2017 updated by: Genentech, Inc.
An Epidemiologic Study of Xolair (Omalizumab): Evaluating Clinical Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma (EXCELS)
This study is a multicenter, prospective, observational cohort study of ~5000 Xolair-treated and ~2500 non-Xolair-treated patients with moderate to severe persistent asthma and a positive skin test or in vitro reactivity to an aeroallergen.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
8023
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients will be recruited from a variety of practice settings, including managed care organizations, community physicians, and academic centers.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dennis Wong, M.D., Genentech, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Eisner MD, Yegin A, Trzaskoma B. Severity of asthma score predicts clinical outcomes in patients with moderate to severe persistent asthma. Chest. 2012 Jan;141(1):58-65. doi: 10.1378/chest.11-0020. Epub 2011 Sep 1.
- Long AA, Fish JE, Rahmaoui A, Miller MK, Bradley MS, Taki HN, Demeo AN, Tilles SA, Szefler SJ. Baseline characteristics of patients enrolled in EXCELS: a cohort study. Ann Allergy Asthma Immunol. 2009 Sep;103(3):212-9. doi: 10.1016/S1081-1206(10)60184-6.
- Wechsler ME, Wong DA, Miller MK, Lawrence-Miyasaki L. Churg-strauss syndrome in patients treated with omalizumab. Chest. 2009 Aug;136(2):507-518. doi: 10.1378/chest.08-2990. Epub 2009 May 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2004
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
November 9, 2005
First Submitted That Met QC Criteria
November 9, 2005
First Posted (Estimate)
November 11, 2005
Study Record Updates
Last Update Posted (Actual)
May 12, 2017
Last Update Submitted That Met QC Criteria
May 11, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Q2948g
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.