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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: MARIPAZ B MORALES, MD CHILDREN'S HOSPITAL OF KING'S DAUGHTERS/EASTERN VIRGINIA MEDICAL SCHOOL
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00283504     History of Changes
Other Study ID Numbers: IRB# 05-08-EX-0247
Study First Received: January 26, 2006
Last Updated: May 25, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014