A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy

Phase 4

Completed

• Conditions: ALLERGIC ASTHMA
• Interventions: Drug: ANTI-IGE THERAPY (XOLAIR)

• Registration Number: NCT00283504
• Lead Sponsor: Children's Hospital of The King's Daughters

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 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)

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-26
• Study First Submitted QC: 2006-01-26
• Study First Posted: 2006-01-30
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2018-02
• Results First Submitted: 2018-02-07
• Results First Submitted QC: 2018-02-07
• Last Update Submitted: 2018-02-07
• Results First Posted: 2018-02-19
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
all patients received Xolair/active drug	ANTI-IGE THERAPY (XOLAIR)	One arm:active drug

Primary Outcome Measures

Name	Time	Method
Number of Participants With Change in Sputum Markers by End of Study	32 weeks	sputum markers were classified as eosinophilic or non eosinophilic

Secondary Outcome Measures

Name	Time	Method
Number Participants for Whom Sputum Induction Was Safe	every 4 weeks up to 32 weeks	safety was assessed by measuring FEV1 levels before and after sputum induction; induction was considered safe if FEV1 levels remained the same or improved
Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control	32 weeks