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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283504
• Other study ID #: IRB# 05-08-EX-0247
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2006
• Last updated: February 7, 2018
• Start date: January 2006
• Est. completion date: January 2009

Study information

• Verified date: February 2018
• Source: Children's Hospital of The King's Daughters
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• ALLERGIC ASTHMA
• Asthma

Intervention

Drug:
• ANTI-IGE THERAPY (XOLAIR)
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of The King's Daughters	Genentech, Inc., Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Change in Sputum Markers by End of Study	sputum markers were classified as eosinophilic or non eosinophilic	32 weeks
Secondary	Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control		32 weeks
Secondary	Number Participants for Whom Sputum Induction Was Safe	safety was assessed by measuring FEV1 levels before and after sputum induction; induction was considered safe if FEV1 levels remained the same or improved	every 4 weeks up to 32 weeks