ALLERGIC ASTHMA Clinical Trial
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)
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.
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