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Allergic AsthmaPhase 4XPORTNCT01125748

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

A Phase 4 study testing Omalizumab and Asthma therapies in people with Allergic Asthma, run by Genentech, Inc. at 100 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 17 to 70 years
Conditions the study is for
Allergic Asthma
What is being tested?
Omalizumab and Asthma therapies
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
176 participants
Where
100 sitesUnited States
Study dates
May 2010to Aug 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

100 sites in 1 country.

100 sites in 1 country

United States100 sites

  • Study site

    Albany, Georgia, 31707

  • Study site

    Albany, New York, 12205

  • Study site

    Altoona, Pennsylvania, 16601

  • Study site

    Asheville, North Carolina, 28801

  • Study site

    Bakersfield, California, 93301

  • Study site

    Baltimore, Maryland, 21236

  • Study site

    Bay Pines, Florida, 33744

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Beavercreek, Ohio, 45434

  • Study site

    Bellevue, Nebraska, 68123

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Carlisle, Pennsylvania, 17013

  • Study site

    Centennial, Colorado, 80112

  • Study site

    Centerville, Ohio, 45458

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Clearwater, Florida, 33765

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Cranford, New Jersey, 07016

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75231

  • Study site

    Edison, New Jersey, 08820

  • Study site

    El Paso, Texas, 79925

  • Study site

    Ellicott City, Maryland, 21042

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Fargo, North Dakota, 58104

  • Study site

    Fort Wayne, Indiana, 46804

  • Study site

    Fort Wayne, Indiana, 46815

  • Study site

    Fresno, California, 93720

  • Study site

    Fresno, California, 93726

  • Study site

    Gainesville, Georgia, 30501

  • Study site

    Gaithersburg, Maryland, 20878

  • Study site

    Gardner, Massachusetts, 01440

  • Study site

    Garland, Texas, 75044

  • Study site

    Glen Carbon, Illinois, 62034

  • Study site

    Granada Hills, California, 91344

  • Study site

    Greenville, South Carolina, 29607

  • Study site

    Harrisburg, Pennsylvania, 17110

  • Study site

    Heath, Texas, 75032

  • Study site

    High Point, North Carolina, 27262

  • Study site

    Hillsborough, New Jersey, 08844

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Knoxville, Tennessee, 37909

  • Study site

    Lexington, Kentucky, 40513

  • Study site

    Liberty, Missouri, 64068

  • Study site

    Lincoln, Rhode Island, 02865

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Los Angeles, California, 90025

  • Study site

    Los Angeles, California, 90064

  • Study site

    Loxahatchee Groves, Florida, 33470

  • Study site

    Madison, Wisconsin, 53715

  • Study site

    Mandeville, Louisiana, 70471

  • Study site

    Metairie, Louisiana, 70002

  • Study site

    Middletown, New York, 10940

  • Study site

    Mineola, New York, 11501

  • Study site

    Mount Vernon, New York, 10552

  • Study site

    Napa, California, 94558

  • Study site

    New Paltz, New York, 12561

  • Study site

    New York, New York, 10022

  • Study site

    Newburgh, New York, 12550

  • Study site

    North Dartmouth, Massachusetts, 02747

  • Study site

    Ocala, Florida, 34471

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Olean, New York, 14760

  • Study site

    Omaha, Nebraska, 68130

  • Study site

    Overland Park, Kansas, 66210

  • Study site

    Park Ridge, Illinois, 60068

  • Study site

    Pensacola, Florida, 32503

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Pittsburgh, Pennsylvania, 15221

  • Study site

    Redwood City, California, 94063

  • Study site

    Richmond, Virginia, 23298

  • Study site

    Rockville Centre, New York, 11570

  • Study site

    Round Rock, Texas, 78681

  • Study site

    Sacramento, California, 95819

  • Study site

    San Antonio, Texas, 78233

  • Study site

    San Antonio, Texas, 78251

  • Study site

    San Francisco, California, 94104

  • Study site

    San Mateo, California, 94401

  • Study site

    Sasint Louis, Missouri, 63104

  • Study site

    Spokane, Washington, 99204

  • Study site

    Springfield, Missouri, 65807

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Staten Island, New York, 10304

  • Study site

    Studio City, California, 91607

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tampa, Florida, 33613

  • Study site

    Taunton, Massachusetts, 02780

  • Study site

    The Bronx, New York, 10423

  • Study site

    The Bronx, New York, 10461

  • Study site

    The Bronx, New York, 10465

  • Study site

    Thornton, Colorado, 80233

  • Study site

    Topeka, Kansas, 66606

  • Study site

    Tulsa, Oklahoma, 74133

  • Study site

    Upland, Pennsylvania, 19013

  • Study site

    Verona, New Jersey, 07044

  • Study site

    Walnut Creek, California, 94598

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    West Palm Beach, Florida, 33401

  • Study site

    Wheeling, West Virginia, 26003

Other trials in United States

About this study

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)

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.

Read the 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).

Conditions
Allergic Asthma
Being tested
Omalizumab, Placebo, Asthma therapies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmalizumabDrug

    Also called Xolair

    Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.

  • PlaceboDrug

    Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.

  • Asthma therapiesDrug

    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.

Study groups in NCT01125748
Study groupRoleWhat they receive
OmalizumabExperimentalParticipants 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.
Receives: Drug: Omalizumab; Drug: Asthma therapies
PlaceboPlacebo comparatorParticipants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
Receives: Drug: Placebo; Drug: Asthma therapies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Not Experiencing a Protocol-defined Severe Exacerbation During the Study

    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.

    Measured: Baseline to the end of the study (up to 52 weeks)

Secondary outcomes (1)

  1. Time to the First Protocol-defined Severe Exacerbation

    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.

    Measured: Baseline to the end of the study (up to 52 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01125748
Sponsor's protocol ID
Q4777n
Other IDs
ML01347
Acronym
XPORT
Status last verified
Oct 2014
First submitted
14 May 2010
Last updated
15 Oct 2014

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Omalizumab and Asthma therapies in people with Allergic Asthma, run by Genentech, Inc. at 100 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01125748.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.

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