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

Asthma Clinical Trial

Official title:

An Epidemiologic Study of Xolair (Omalizumab): Evaluating Clinical Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma (EXCELS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252135
• Other study ID #: Q2948g
• Status: Completed
• Phase: N/A
• First received: November 9, 2005
• Last updated: May 11, 2017
• Start date: June 2004
• Est. completion date: November 2011

Study information

• Verified date: May 2017
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8023
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.