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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00283504
First Posted: January 30, 2006
Last Update Posted: May 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Novartis
Genentech, Inc.
Information provided by:
Children's Hospital of The King's Daughters
  Purpose

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 Intervention Phase
Allergic Asthma Drug: ANTI-IGE THERAPY (XOLAIR) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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)

Resource links provided by NLM:


Further study details as provided by Children's Hospital of The King's Daughters:

Primary Outcome Measures:
  • description of sputum inflammatory markers

Secondary Outcome Measures:
  • improvement in lung functions and symptoms scores

Estimated Enrollment: 40
Study Start Date: January 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 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
  Contacts and Locations
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


Locations
United States, Virginia
Children'S Hospital of King'S Daughters
Norfolk, Virginia, United States, 23507
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
  More Information

ClinicalTrials.gov Identifier: NCT00283504     History of Changes
Other Study ID Numbers: IRB# 05-08-EX-0247
First Submitted: January 26, 2006
First Posted: January 30, 2006
Last Update Posted: May 27, 2010
Last Verified: January 2006

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