Document Detail


A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis.
MedLine Citation:
PMID:  21038023     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Evidence suggests IgE may play a role in chronic rhinosinusitis (CRS). We sought to determine if treatment with a monoclonal antibody against IgE (omalizumab) is effective in reducing CRS inflammation. We performed a randomized, double blind, placebo controlled clinical trial in subjects with CRS despite treatment (including surgery). Subjects were randomized to receive omalizumab or placebo for 6 months. The primary outcome was quantitative measurement of sinus inflammation on imaging. Secondary outcome measures included quality of life, symptoms, and cellular inflammation, nasal airflow (NPIF) and olfactory testing (UPSIT). Subjects on omalizumab showed reduced inflammation on imaging after treatment, whereas those on placebo showed no change. The net difference, however, was not different between treatments. Treatment with omalizumab was associated with improvement in the Sino-Nasal Outcome Test (SNOT-20) at 3, 5, and 6 months compared to baseline with no significant changes in the control group. Remaining measures showed no significant differences across treatments. We conclude that IgE plays, at most, a small role in the mucosal inflammation of CRS and the symptoms. Placebo controlled, blinded studies with larger enrollment are needed to determine the clinical significance of any potential change.
Authors:
J M Pinto; N Mehta; M DiTineo; J Wang; F M Baroody; R M Naclerio
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Rhinology     Volume:  48     ISSN:  0300-0729     ISO Abbreviation:  Rhinology     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-11-01     Completed Date:  2010-12-07     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0347242     Medline TA:  Rhinology     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  318-24     Citation Subset:  IM    
Affiliation:
Department of Surgery, Section of Otolaryngology-Head and Neck Surgery, The University of Chicago, Chicago, IL 60637, USA.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00117611
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-Allergic Agents / therapeutic use*
Antibodies, Monoclonal / therapeutic use*
Chronic Disease
Double-Blind Method
Female
Health Status Indicators
Humans
Immunoglobulin E / physiology
Male
Middle Aged
Quality of Life
Rhinitis / drug therapy*,  physiopathology
Sinusitis / drug therapy*,  physiopathology
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anti-Allergic Agents; 0/Antibodies, Monoclonal; 0/omalizumab; 37341-29-0/Immunoglobulin E

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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