A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy
Condition: Allergic Asthma
Intervention: Omalizumab; Placebo; Asthma therapies
Intervention description: Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.; Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.; 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.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 176.0
Sex: All
Minimum age: 17 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

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.