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.
Minimum age: 17 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Huntsville, Alabama 35801, United States
Little Rock, Arkansas 72205, United States
Bakersfield, California 93301, United States
Fresno, California 93720, United States
Fresno, California 93726, United States
Granada Hills, California 91344, United States
Los Angeles, California 90064, United States
Los Angeles, California 90025, United States
Napa, California 94558, United States
Redwood City, California 94063, United States
Sacramento, California 95819, United States
San Francisco, California 94104, United States
San Mateo, California 94401, United States
Studio City, California 91607, United States
Walnut Creek, California 94598, United States
Centennial, Colorado 80112, United States
Thornton, Colorado 80233, United States
Waterbury, Connecticut 06708, United States
Bay Pines, Florida 33744, United States
Clearwater, Florida 33765, United States
Loxahatchee, Florida 33470, United States
Ocala, Florida 34471, United States
Pensacola, Florida 32503, United States
Tampa, Florida 33613, United States
West Palm Beach, Florida 33401, United States
Albany, Georgia 31707, United States
Columbus, Georgia 31904, United States
Gainesville, Georgia 30501, United States
Chicago, Illinois 60612, United States
Glen Carbon, Illinois 62034, United States
Park Ridge, Illinois 60068, United States
Fort Wayne, Indiana 46804, United States
Fort Wayne, Indiana 46815, United States
Overland Park, Kansas 66210, United States
Topeka, Kansas 66606, United States
Lexington, Kentucky 40513, United States
Mandeville, Louisiana 70471, United States
Metairie, Louisiana 70002, United States
Baltimore, Maryland 21236, United States
Ellicott City, Maryland 21042, United States
Gaithersburg, Maryland 20878, United States
Boston, Massachusetts 02114, United States
Gardner, Massachusetts 01440, United States
North Dartmouth, Massachusetts 02747, United States
Taunton, Massachusetts 02780, United States
Liberty, Missouri 64068, United States
Saint Louis, Missouri 63141, United States
Sasint Louis, Missouri 63104, United States
Springfield, Missouri 65807, United States
St Louis, Missouri 63141, United States
St. Louis, Missouri 63110, United States
Bellevue, Nebraska 68123, United States
Omaha, Nebraska 68130, United States
Cranford, New Jersey 07016, United States
Edison, New Jersey 08820, United States
Hillsborough, New Jersey 08844, United States
Verona, New Jersey 07044, United States
Albany, New York 12205, United States
Bronx, New York 10423, United States
Bronx, New York 10461, United States
Bronx, New York 10465, United States
Middletown, New York 10940, United States
Mineola, New York 11501, United States
Mount Vernon, New York 10552, United States
New Paltz, New York 12561, United States
New York, New York 10022, United States
Newburgh, New York 12550, United States
Olean, New York 14760, United States
Rockville Center, New York 11570, United States
Staten Island, New York 10304, United States
Asheville, North Carolina 28801, United States
High Point, North Carolina 27262, United States
Fargo, North Dakota 58103, United States
Fargo, North Dakota 58104, United States
Beaver Creek, Ohio 45434, United States
Centerville, Ohio 45458, United States
Oklahoma City, Oklahoma 73112, United States
Tulsa, Oklahoma 74133, United States
Altoona, Pennsylvania 16601, United States
Beaver, Pennsylvania 15009, United States
Carlisle, Pennsylvania 17013, United States
Harrisburg, Pennsylvania 17110, United States
Pittsburgh, Pennsylvania 15213, United States
Pittsburgh, Pennsylvania 15221, United States
Upland, Pennsylvania 19013, United States
Lincoln, Rhode Island 02865, United States
Greenville, South Carolina 29607, United States
Knoxville, Tennessee 37909, United States
Dallas, Texas 75230, United States
Dallas, Texas 75231, United States
El Paso, Texas 79925, United States
Garland, Texas 75044, United States
Heath, Texas 75032, United States
Round Rock, Texas 78681, United States
San Antonio, Texas 78233, United States
San Antonio, Texas 78251, United States
Richmond, Virginia 23298, United States
Spokane, Washington 99204, United States
Tacoma, Washington 98405, United States
Wheeling, West Virginia 26003, United States
Madison, Wisconsin 53715, United States