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
  Purpose

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.


Condition Phase
Asthma
Phase 4

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Genentech:

Enrollment: 8023
Study Start Date: June 2004
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252135

Sponsors and Collaborators
Genentech
Investigators
Study Director: Dennis Wong, M.D. Genentech
  More Information

No publications provided by Genentech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00252135     History of Changes
Other Study ID Numbers: Q2948g
Study First Received: November 9, 2005
Last Updated: November 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Moderate to severe asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014