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A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00252135
First received: November 9, 2005
Last updated: May 11, 2017
Last verified: May 2017
November 9, 2005
May 11, 2017
June 2004
November 2011   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00252135 on ClinicalTrials.gov Archive Site
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A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients will be recruited from a variety of practice settings, including managed care organizations, community physicians, and academic centers.
Asthma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8023
November 2011
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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United States
 
NCT00252135
Q2948g
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Genentech, Inc.
Genentech, Inc.
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Study Director: Dennis Wong, M.D. Genentech, Inc.
Genentech, Inc.
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP