Skip to main content
OpenTrials
Completed

NCT Number: NCT00283504

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Asthma

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANTI-IGE THERAPY (XOLAIR)

Drug

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.

Primary outcomes

  1. Number of Participants With Change in Sputum Markers by End of Study

    Time frame: 32 weeks

    sputum markers were classified as eosinophilic or non eosinophilic

Secondary outcomes

  1. Number of Participants With Response to Therapy Based on Clinical Parameters Such as ED Visits, Hospitalizations, Systemic Steroid Use and Symptom Control

    Time frame: 32 weeks

  2. Number Participants for Whom Sputum Induction Was Safe

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of The King's Daughters

Other

Collaborators

  • Genentech, Inc.
  • Novartis

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 30, 2006
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.