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Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Omalizumab
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, anti-immunoglobulin E, omalizumab, allergic asthma

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Patients with a history of severe allergic asthma who completed the treatment period of CIGE250011E3 protocol, without experiencing any significant drug-related adverse events
  • Male or female patients 12-75 years of age who have given written informed consent approved by the ethical committee

Exclusion Criteria:

  • Patients who had not received study medication for greater than 84 days since visit 38 of study CIGE240011E3
  • Pregnant females or nursing mothers
  • Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety assessed by adverse events, serious adverse events, hematology, blood chemistry and urinalysis value, vital signs data, the performance of physical examinations and body weight measurements.

    Secondary Outcome Measures

    Efficacy assessed by changes in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC), the investigator's assessment of asthma control, corticosteroid use, the incidence of hospitalization and outpatients visits, and absenteeism fr

    Full Information

    First Posted
    June 4, 2007
    Last Updated
    November 16, 2016
    Sponsor
    Novartis
    Collaborators
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00482248
    Brief Title
    Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma
    Official Title
    An Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Adults and Adolescents With Severe Allergic Asthma Who Participated in the 52 Week CIGE250011E2 Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2003 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Novartis
    Collaborators
    Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Asthma, anti-immunoglobulin E, omalizumab, allergic asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    132 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Omalizumab
    Primary Outcome Measure Information:
    Title
    Safety assessed by adverse events, serious adverse events, hematology, blood chemistry and urinalysis value, vital signs data, the performance of physical examinations and body weight measurements.
    Secondary Outcome Measure Information:
    Title
    Efficacy assessed by changes in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC), the investigator's assessment of asthma control, corticosteroid use, the incidence of hospitalization and outpatients visits, and absenteeism fr

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    75 Years
    Eligibility Criteria
    Inclusion Criteria: Patients with a history of severe allergic asthma who completed the treatment period of CIGE250011E3 protocol, without experiencing any significant drug-related adverse events Male or female patients 12-75 years of age who have given written informed consent approved by the ethical committee Exclusion Criteria: Patients who had not received study medication for greater than 84 days since visit 38 of study CIGE240011E3 Pregnant females or nursing mothers Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs Other protocol-defined inclusion/exclusion criteria may apply
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma

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