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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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:
- pulmonary function test (PFT)
- 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) |
- description of sputum inflammatory markers
- 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) |
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 |
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| United States, Virginia | |
| Children'S Hospital of King'S Daughters | |
| Norfolk, Virginia, United States, 23507 | |
| 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 May 19, 2013