Clinical trial NCT00252135: A Study of Xolair to Evaluate Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma
Official title: An Epidemiologic Study of Xolair (Omalizumab): Evaluating Clinical Effectiveness and Long-Term Safety in Patients With Moderate to Severe Asthma (EXCELS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Moderate to severe asthma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2005-11-11
Enrollment: 8023
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Dennis Wong, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.