NCT00252135

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,023

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2004

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

7.4 years

First QC Date

November 9, 2005

Last Update Submit

May 11, 2017

Conditions

Asthma

Keywords

Moderate to severe asthma

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruited from a variety of practice settings, including managed care organizations, community physicians, and academic centers.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Fiocchi A, Chinthrajah RS, Ansotegui IJ, Sriaroon P, Mustafa SS, Raut P, Cameron B, Gupta S, Fleischer DM. Does Comorbid Food Allergy Affect Response to Omalizumab in Patients with Asthma? J Asthma Allergy. 2024 Sep 17;17:889-900. doi: 10.2147/JAA.S475517. eCollection 2024.

    PMID: 39309477DERIVED

  • 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.

    PMID: 21885725DERIVED

  • 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.

    PMID: 19788018DERIVED

  • 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.

    PMID: 19411292DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Dennis Wong, M.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 11, 2005

Study Start

June 1, 2004

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

May 12, 2017

Record last verified: 2017-05