Title
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)
Phase
Phase 4Lead Sponsor
Old Dominion UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
ALLERGIC ASTHMAIntervention/Treatment
omalizumab ...Study Participants
13The 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)
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.
Xolair dosing is based on body weight and baseline serum total IgE concentration(0.016 x kg body weight x IgE levels), with a maximum dose per 4 weeks of 750mg.Depending on their weight and IgE levels, patients get their Xolair shots every 2 or every 4 weeks.
One arm:active drug
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
| Event Type | Organ System | Event Term |
|---|
sputum markers were classified as eosinophilic or non eosinophilic
safety was assessed by measuring FEV1 levels before and after sputum induction; induction was considered safe if FEV1 levels remained the same or improved
