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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01125748
First received: May 14, 2010
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

This is a randomized, double-blind, placebo-controlled, two-armed, one-year stud y of patients who have completed the EXCELS study (NCT00252135) and have receive d long-term treatment with Xolair. In addition, patients will be allowed to ente r the study who did not participate in the EXCELS study but received long-term (

~5 years) treatment with Xolair.


Condition Intervention Phase
Allergic Asthma
Drug: omalizumab
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Any protocol-defined severe exacerbation [ Time Frame: Throughout study (52 weeks) or until early discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first protocol-defined severe exacerbation [ Time Frame: From initiation of study treatment to event (overall study is 52 weeks) ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: May 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: omalizumab
Administered subcutaneously according to dose and dosing interval as administered prior to enrollment to this study.
Placebo Comparator: B Drug: placebo
Administered subcutaneously according to dose and dosing interval as administered prior to enrollment to this study.

  Eligibility

Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Both
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
  • Patients who have completed EXCELS prior to this study must have met all inclusion criteria for enrollment in EXCELS
  • History of positive skin test or in vitro reactivity to an aeroallergen
  • Continuous Xolair exposure from the beginning of EXCELS to randomization into this study (if the patient participated in EXCELS), or within the previous 5 years prior to randomization into this study (if the patient did not participate in EXCELS). 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 patients who did not participate in the EXCELS study, missed-dose rates will be based on their injection records
  • Patients who participated in EXCELS must have completed EXCELS and not discontinued Xolair since the completion of EXCELS
  • 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 two months prior to enrollment
  • Serum IgE level >/= 30 to </= 700 IU/mL before initiation of Xolair treatment (prior to EXCELS enrollment or earlier)
  • Body weight >/=30 to </= 150 kg
  • Treatment with Xolair consistent with the USPI (based on the dosing table, recommended dose, administration, and dosing interval) prior to enrollment to this study
  • Patients who participated in EXCELS must be willing to allow their EXCELS data to be used in this study as part of baseline demographic values (such as FEV1 and ACT), as documented in ICF

Exclusion Criteria:

  • Participation in other therapy trials or planned participation during the following year from screening
  • Contraindication to Xolair therapy (e.g., patients 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 ICS dosing, emergency room visit, and hospitalization
  • Any significant, or unstable, systemic disease (e.g., 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 (e.g. spirometry, blood draws).
  • Have elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich syndrome, or bronchopulmonary aspergillosis)
  • Pregnancy, lactation or any planned pregnancy in the following year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125748

  Show 101 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01125748     History of Changes
Other Study ID Numbers: Q4777n, ML01347
Study First Received: May 14, 2010
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 27, 2014