Clinical trial NCT01125748: A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy
Official title: A Phase IV, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Persistency of Response With or Without Xolair After Long-term Therapy (XPORT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Asthma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 176
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a randomized, double-blind, placebo-controlled, 2-arm, 1-year study of participants who completed the EXCELS study (NCT00252135) and had received long-term treatment with Xolair. In addition, participants who did not participate in the EXCELS study but received long-term (\~5 years) treatment with Xolair were allowed to enter the study.

Detailed description: The treatment designation for participants who reached the primary efficacy endpoint (1 protocol-defined severe asthma exacerbation) was unblinded to allow appropriate clinical intervention. Participants who had their treatment designation unblinded remained in the study for ongoing evaluation of safety and were allowed to continue on study drug known to be Xolair (or to start study drug known to be Xolair if they were in the placebo group).

Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form (ICF). In the case of a minor, consent must be given by the child's parent or legally authorized representative.
* Participants who have completed the EXCELS study prior to this study must have met all inclusion criteria for enrollment in the EXCELS study.
* History of positive skin test or in vitro reactivity to an aeroallergen.
* Continuous Xolair (omalizumab) exposure from the beginning of the EXCELS study to randomization into this study (if the participant participated in the EXCELS study), or within the previous 5 years prior to randomization into this study (if the participant did not participate in the EXCELS study). For the purposes of this study, continuous Xolair exposure is defined as having missed no more than 25% of scheduled Xolair doses. In addition, a maximum of 2 doses can be missed within the last 6 months before being randomized into this study. For participants who did not participate in the EXCELS study, missed-dose rates will be based on their injection records.
* Patients who participated in the EXCELS study must have completed the EXCELS study and not discontinued Xolair since the completion of the EXCELS study.
* Diagnosis of moderate to severe persistent allergic asthma while on Xolair as defined per physician's assessment.
* Stable dosing of current asthma therapies, in addition to Xolair, over 2 months prior to enrollment.
* Serum IgE level ≥ 30 to ≤ 700 IU/mL before initiation of Xolair treatment (prior to the EXCELS study enrollment or earlier).
* Body weight ≥ 30 to ≤ 150 kg.
* Treatment with Xolair consistent with the US package insert (USPI) (based on the dosing table, recommended dose, administration, and dosing interval) prior to enrollment to this study.
* Participants who participated in the EXCELS study must be willing to allow their EXCELS study data to be used in this study as part of baseline demographic values (such as forced expiratory volume in 1 second \[FEV1\] and Asthma Control Test \[ACT\]), as documented in the ICF.

Exclusion Criteria:

* Participation in other therapy trials or planned participation during the following year from screening.
* Contraindication to Xolair therapy (eg, participants who experienced a severe hypersensitivity reaction to Xolair).
* Acute asthma exacerbation within the 2 months immediately prior to screening that required any of the following: Initiation of systemic corticosteroids, increased dosing of systemic corticosteroids relative to "stable" dose, doubling of inhaled corticosteroid (ICS) dosing, emergency room visit, and hospitalization.
* Any significant, or unstable, systemic disease (eg, infection, hematologic, renal, hepatic, cardiovascular diseases, or gastrointestinal diseases), or a recent hospitalization because of systemic disease within the previous 2 months.
* Diagnosis of active lung disease other than asthma.
* Having more than 10 pack-years smoking history.
* Diagnosis of cystic fibrosis.
* Use of an experimental drug within 30 days prior to study screening.
* Unable or unwilling to comply with study procedures and visits (eg, spirometry, blood draws).
* Have elevated serum IgE levels for reasons other than allergy (eg, parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich syndrome, or bronchopulmonary aspergillosis).
* Pregnancy, lactation, or any planned pregnancy in the following year.

Primary outcomes:
measure: Percentage of Participants Not Experiencing a Protocol-defined Severe Exacerbation During the Study
timeFrame: Baseline to the end of the study (up to 52 weeks)
Secondary outcomes:
measure: Time to the First Protocol-defined Severe Exacerbation
timeFrame: Baseline to the end of the study (up to 52 weeks)
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Bakersfield
country: United States
state: California
city: Fresno
country: United States
state: California
city: Fresno
country: United States
state: California
city: Granada Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Napa
country: United States
state: California
city: Redwood City
country: United States
state: California
city: Sacramento
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state: California
city: San Francisco
country: United States
state: California
city: San Mateo
country: United States
state: California
city: Studio City
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Thornton
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Bay Pines
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Loxahatchee
country: United States
state: Florida
city: Ocala
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state: Florida
city: Pensacola
country: United States
state: Florida
city: Tampa
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state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Albany
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state: Georgia
city: Columbus
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state: Georgia
city: Gainesville
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state: Georgia
city: Chicago
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state: Illinois
city: Glen Carbon
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state: Illinois
city: Park Ridge
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state: Illinois
city: Fort Wayne
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state: Indiana
city: Fort Wayne
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state: Indiana
city: Overland Park
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state: Kansas
city: Topeka
country: United States
state: Kansas
city: Lexington
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state: Kentucky
city: Mandeville
country: United States
state: Louisiana
city: Metairie
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Ellicott City
country: United States
state: Maryland
city: Gaithersburg
country: United States
state: Maryland
city: Boston
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state: Massachusetts
city: Gardner
country: United States
state: Massachusetts
city: North Dartmouth
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state: Massachusetts
city: Taunton
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state: Massachusetts
city: Liberty
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state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Sasint Louis
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Bellevue
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Cranford
country: United States
state: New Jersey
city: Edison
country: United States
state: New Jersey
city: Hillsborough
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state: New Jersey
city: Verona
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state: New Jersey
city: Albany
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state: New York
city: Bronx
country: United States
state: New York
city: Bronx
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state: New York
city: Bronx
country: United States
state: New York
city: Middletown
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: Mount Vernon
country: United States
state: New York
city: New Paltz
country: United States
state: New York
city: New York
country: United States
state: New York
city: Newburgh
country: United States
state: New York
city: Olean
country: United States
state: New York
city: Rockville Center
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Beaver Creek
country: United States
state: Ohio
city: Centerville
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Altoona
country: United States
state: Pennsylvania
city: Beaver
country: United States
state: Pennsylvania
city: Carlisle
country: United States
state: Pennsylvania
city: Harrisburg
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Upland
country: United States
state: Pennsylvania
city: Lincoln
country: United States
state: Rhode Island
city: Greenville
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Dallas
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state: Texas
city: Dallas
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Garland
country: United States
state: Texas
city: Heath
country: United States
state: Texas
city: Round Rock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Wheeling
country: United States
state: West Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: