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A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy

Primary Purpose

ALLERGIC ASTHMA

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ANTI-IGE THERAPY (XOLAIR)
Sponsored by
Children's Hospital of The King's Daughters
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ALLERGIC ASTHMA

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Moderate to severe allergic asthma, uncontrolled on conventional therapy Exclusion Criteria: History of systemic illness, currently on other immune modulators like immunotherapy, IVIg Pregnancy IgE level >1300

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    all patients received Xolair/active drug

    Arm Description

    One arm:active drug

    Outcomes

    Primary Outcome Measures

    Number of Participants With Change in Sputum Markers by End of Study
    sputum markers were classified as eosinophilic or non eosinophilic

    Secondary Outcome Measures

    Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control
    Number Participants for Whom Sputum Induction Was Safe
    safety was assessed by measuring FEV1 levels before and after sputum induction; induction was considered safe if FEV1 levels remained the same or improved

    Full Information

    First Posted
    January 26, 2006
    Last Updated
    February 7, 2018
    Sponsor
    Children's Hospital of The King's Daughters
    Collaborators
    Novartis, Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00283504
    Brief Title
    A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy
    Official Title
    A Description of Inflammatory Cell Types in Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy (Xolair)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    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
    Children's Hospital of The King's Daughters
    Collaborators
    Novartis, Genentech, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The researcher proposes to assess levels of sputum inflammatory markers (eosinophils, eosinophil cationic protein (ECP), neutrophils IL-8) before and while on anti-IgE therapy in a pediatric population of moderate to severe asthmatics who have ongoing persistent asthma symptoms despite on moderate to high doses of inhaled corticosteroids (ICS). Associations will be assessed between the types of sputum inflammatory markers and the patient's atopic status and level of asthma control as indicated by the following measures: pulmonary function test (PFT) asthma symptoms based on the Asthma Control Test (ACT)
    Detailed Description
    Objectives: Primary: Describe inflammatory cell types in study patients and compare changes in inflammatory cell patterns before and during anti-IgE therapy. Secondary:Describe patterns of sputum eosinophilia and neutrophilia in relation to asthma symptom improvement based on ACT and PFT Hypotheses: Differences in inflammatory response after the addition of anti-IgE therapy can be described in neutrophilic, eosinophilic and neutrophilic/eosinophilic asthmatics. Neutrophilic asthmatics patients will fail to respond when placed on anti-IgE while eosinophilic asthmatics will respond well. Sputum inflammatory markers are sensitive markers of inflammation and can predict response to new asthma treatment modalities such as anti-IgE therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ALLERGIC ASTHMA

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    all patients received Xolair/active drug
    Arm Type
    Experimental
    Arm Description
    One arm:active drug
    Intervention Type
    Drug
    Intervention Name(s)
    ANTI-IGE THERAPY (XOLAIR)
    Intervention Description
    Xolair dosing is based on body weight and baseline serum total IgE concentration(0.016 x kg body weight x IgE levels), with a maximum dose per 4 weeks of 750mg.Depending on their weight and IgE levels, patients get their Xolair shots every 2 or every 4 weeks.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Change in Sputum Markers by End of Study
    Description
    sputum markers were classified as eosinophilic or non eosinophilic
    Time Frame
    32 weeks
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control
    Time Frame
    32 weeks
    Title
    Number Participants for Whom Sputum Induction Was Safe
    Description
    safety was assessed by measuring FEV1 levels before and after sputum induction; induction was considered safe if FEV1 levels remained the same or improved
    Time Frame
    every 4 weeks up to 32 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Moderate to severe allergic asthma, uncontrolled on conventional therapy Exclusion Criteria: History of systemic illness, currently on other immune modulators like immunotherapy, IVIg Pregnancy IgE level >1300
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MARIPAZ B MORALES, MD
    Organizational Affiliation
    CHILDREN'S HOSPITAL OF KING'S DAUGHTERS/EASTERN VIRGINIA MEDICAL SCHOOL
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy

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