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

About this trial
This is an interventional diagnostic trial for ALLERGIC ASTHMA
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
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
NCT ID
NCT00283504
First Posted
January 26, 2006
Last Updated
February 7, 2018
Sponsor
Children's Hospital of The King's Daughters
Collaborators
Novartis, Genentech, Inc.
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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