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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
ClinicalTrials.gov Identifier:
NCT00252135
First received: November 9, 2005
Last updated: November 23, 2011
Last verified: November 2011
History of Changes

November 9, 2005
November 23, 2011
June 2004
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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
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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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00252135
Q2948g
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Genentech
Genentech
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Study Director: Dennis Wong, M.D. Genentech
Genentech
November 2011

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