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:
Collaborators:
Novartis
Genentech
Information provided by:
Children's Hospital of The King's Daughters
ClinicalTrials.gov Identifier:
NCT00283504
First received: January 26, 2006
Last updated: May 25, 2010
Last verified: January 2006

January 26, 2006
May 25, 2010
January 2006
January 2009   (final data collection date for primary outcome measure)
description of sputum inflammatory markers
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Complete list of historical versions of study NCT00283504 on ClinicalTrials.gov Archive Site
improvement in lung functions and symptoms scores
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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
A Description of Inflammatory Cell Types in Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy (Xolair)

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)

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Allergic Asthma
Drug: ANTI-IGE THERAPY (XOLAIR)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
12 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00283504
IRB# 05-08-EX-0247
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Children's Hospital of The King's Daughters
  • Novartis
  • Genentech
Principal Investigator: MARIPAZ B MORALES, MD CHILDREN'S HOSPITAL OF KING'S DAUGHTERS/EASTERN VIRGINIA MEDICAL SCHOOL
Children's Hospital of The King's Daughters
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP