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A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy (XPORT)

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ClinicalTrials.gov Identifier: NCT01125748
Recruitment Status : Completed
First Posted : May 18, 2010
Results First Posted : October 15, 2014
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Allergic Asthma Drug: Omalizumab Drug: Placebo Drug: Asthma therapies Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2010
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Omalizumab
Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
Drug: Omalizumab
Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.
Other Name: Xolair
Drug: Asthma therapies
Participants could receive 1 or more of the following medications as concomitant asthma therapy: Inhaled corticosteroids; long acting beta-agonists; zafirlukast or other leukotriene receptor antagonist; zileuton or other 5-lipoxygenase enzyme inhibitors; oral, inhaled, and/or nasal anticholinergic therapy; mast-cell stabilizers; theophyllines; chronic oral corticosteroids, defined as a minimum dose of oral prednisone of 2 to 40 mg/day or 5 to 80 mg every other day.
Placebo Comparator: Placebo
Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
Drug: Placebo
Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.
Drug: Asthma therapies
Participants could receive 1 or more of the following medications as concomitant asthma therapy: Inhaled corticosteroids; long acting beta-agonists; zafirlukast or other leukotriene receptor antagonist; zileuton or other 5-lipoxygenase enzyme inhibitors; oral, inhaled, and/or nasal anticholinergic therapy; mast-cell stabilizers; theophyllines; chronic oral corticosteroids, defined as a minimum dose of oral prednisone of 2 to 40 mg/day or 5 to 80 mg every other day.



Primary Outcome Measures :
  1. Percentage of Participants Not Experiencing a Protocol-defined Severe Exacerbation During the Study [ Time Frame: Baseline to the end of the study (up to 52 weeks) ]
    A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.


Secondary Outcome Measures :
  1. Time to the First Protocol-defined Severe Exacerbation [ Time Frame: Baseline to the end of the study (up to 52 weeks) ]
    A protocol-defined severe exacerbation was a clinically significant worsening of asthma which, in the clinical judgment of the investigator, required at least 1 of the following: (1) Initiation of systemic corticosteroid treatment (tablets, suspension, or injection) or an increase in the level of systemic corticosteroid treatment from a stable maintenance dose for at least 3 days (For patients taking chronic oral corticosteroids, a protocol-defined severe exacerbation was any clinically significant worsening of asthma requiring ≥ 3 days of treatment with at least a 20 mg increase in the average daily dose of oral prednisone or a comparable dose of systemic corticosteroids) or (2) a hospitalization or emergency room visit because of asthma requiring systemic corticosteroids.



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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125748


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

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01125748     History of Changes
Other Study ID Numbers: Q4777n
ML01347 ( Other Identifier: Hoffmann-La Roche )
First Posted: May 18, 2010    Key Record Dates
Results First Posted: October 15, 2014
Last Update Posted: October 15, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents