CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 13 enrolled
Drug / intervention
ANTI-IGE THERAPY (XOLAIR)drug
Likely dose
ANTI-IGE THERAPY (XOLAIR) 750mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00283504
NCT00283504Phase 4Completed
CompareCT.gov

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

Children's Hospital of The King's Daughters·interventional·Posted Jan 30, 2006·Updated Feb 19, 2018

In Brief

A Phase 4 clinical trial evaluating ANTI-IGE THERAPY (XOLAIR) for ALLERGIC ASTHMA. Completed, enrolled 13 participants.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsALLERGIC ASTHMA
Countries--
CollaboratorsNovartis, Genentech, Inc.

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2006
Enrollment StartJan 1, 2006
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.4 years ago

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.