Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283504
Status:
COMPLETED
Last Update Posted:
2018-02-19
First Post:
2006-01-26
Brief Title:
A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy
Sponsor:
Childrens Hospital of The Kings Daughters
Organization:
Childrens Hospital of The Kings Daughters
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
Associations will be assessed between the types of sputum inflammatory markers and the patients 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
Detailed Description:
Objectives
Primary Describe inflammatory cell types in study patients and compare changes in inflammatory cell patterns before and during anti-IgE therapy
SecondaryDescribe 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 neutrophiliceosinophilic 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
Primary Describe inflammatory cell types in study patients and compare changes in inflammatory cell patterns before and during anti-IgE therapy
SecondaryDescribe 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 neutrophiliceosinophilic 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None