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

NCT00283504 | Completed Phase 4 Results

• 1 other identifier: IRB# 05-08-EX-0247
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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. 1.pulmonary function test (PFT)
2. 2.asthma symptoms based on the Asthma Control Test (ACT)

Conditions

ALLERGIC ASTHMA

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Change in Sputum Markers by End of Study

  sputum markers were classified as eosinophilic or non eosinophilic

  32 weeks

Secondary Outcomes (2)

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

  32 weeks

• Number Participants for Whom Sputum Induction Was Safe

  every 4 weeks up to 32 weeks

Study Arms (1)

all patients received Xolair/active drug

EXPERIMENTAL

One arm:active drug

Drug: ANTI-IGE THERAPY (XOLAIR)

Interventions

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.

all patients received Xolair/active drug

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Moderate to severe allergic asthma, uncontrolled on conventional therapy

You may not qualify if:

• History of systemic illness, currently on other immune modulators like immunotherapy, IVIg
• Pregnancy
• IgE level \>1300

Sponsors & Collaborators

• Children's Hospital of The King's Daughters: lead
• Novartis: collaborator
• Genentech, Inc.: collaborator

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Limitations and Caveats

Difficulty enrolling patients and therefore had a small study population, limiting the results of the study.

Results Point of Contact

• Title: MARIPAZ MORALES MD
• Organization: CHILDREN'S HOSPITAL OF THE KING'S DAUGHTERS

MARIPAZ.MORALES@CHKD.ORG

7576688255

Study Officials

• MARIPAZ B MORALES, MD

  CHILDREN'S HOSPITAL OF KING'S DAUGHTERS/EASTERN VIRGINIA MEDICAL SCHOOL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 26, 2006
• First Posted: January 30, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 19, 2018
• Results First Posted: February 19, 2018

Record last verified: 2018-02