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A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma

Primary Purpose

Allergy Induced Asthma

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
omalizumab
Sponsored by
Bernstein Clinical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy Induced Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ages 18-65 occupation that involves close contact with animals stable dose of ICS for 30 days Skin test positive to one or more animals evidence of asthma on spirometry demonstrate PEFR variability- Exclusion Criteria: on allergen immunotherapy on prohibited medications unstable asthma recent URI known hypersensitivity to omalizumab-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    omalizumab

    Arm Description

    open-label

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 17, 2005
    Last Updated
    July 8, 2019
    Sponsor
    Bernstein Clinical Research Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00242359
    Brief Title
    A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
    Official Title
    A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    could not find subject population
    Study Start Date
    November 2005 (Actual)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bernstein Clinical Research Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Management of animal induced occupational asthma is mainly avoidance, but this is not feasible for many occupations. Treatment with avoidance and conventional treatment is also not always successful. Omalizumab is FDA approved for the treatment of allergic asthma and may be effective at reducing symptoms and disease progression in the animal handlers population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergy Induced Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    omalizumab
    Arm Type
    Other
    Arm Description
    open-label
    Intervention Type
    Drug
    Intervention Name(s)
    omalizumab

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ages 18-65 occupation that involves close contact with animals stable dose of ICS for 30 days Skin test positive to one or more animals evidence of asthma on spirometry demonstrate PEFR variability- Exclusion Criteria: on allergen immunotherapy on prohibited medications unstable asthma recent URI known hypersensitivity to omalizumab-

    12. IPD Sharing Statement

    Learn more about this trial

    A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma

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