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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

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ClinicalTrials.gov Identifier: NCT00283504
Recruitment Status : Completed
First Posted : January 30, 2006
Results First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Collaborators:
Novartis
Genentech, Inc.
Information provided by (Responsible Party):
MARIPAZ B. MORALES MD, Children's Hospital of The King's Daughters

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:

  1. pulmonary function test (PFT)
  2. asthma symptoms based on the Asthma Control Test (ACT)

Condition or disease Intervention/treatment Phase
ALLERGIC ASTHMA Drug: ANTI-IGE THERAPY (XOLAIR) Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 2006
Primary Completion Date : January 2009
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: all patients received Xolair/active drug
One arm:active drug
Drug: ANTI-IGE THERAPY (XOLAIR)
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 Measures :
  1. Number of Participants With Change in Sputum Markers by End of Study [ Time Frame: 32 weeks ]
    sputum markers were classified as eosinophilic or non eosinophilic


Secondary Outcome Measures :
  1. 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 ]
  2. Number Participants for Whom Sputum Induction Was Safe [ Time Frame: every 4 weeks up to 32 weeks ]
    safety was assessed by measuring FEV1 levels before and after sputum induction; induction was considered safe if FEV1 levels remained the same or improved



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283504


Sponsors and Collaborators
Children's Hospital of The King's Daughters
Novartis
Genentech, Inc.
Investigators
Principal Investigator: MARIPAZ B MORALES, MD CHILDREN'S HOSPITAL OF KING'S DAUGHTERS/EASTERN VIRGINIA MEDICAL SCHOOL

Responsible Party: MARIPAZ B. MORALES MD, MD, Children's Hospital of The King's Daughters
ClinicalTrials.gov Identifier: NCT00283504     History of Changes
Other Study ID Numbers: IRB# 05-08-EX-0247
First Posted: January 30, 2006    Key Record Dates
Results First Posted: February 16, 2018
Last Update Posted: February 16, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Antibodies, Anti-Idiotypic
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Immunologic Factors
Physiological Effects of Drugs