CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Xolair placebo +1 moredrug
Likely dose
Not stated in 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/NCT01066104
NCT01066104Phase 2Completed

Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis

Massachusetts General Hospital·interventional·Posted Feb 10, 2010·Updated Jun 14, 2017

In Brief

A Phase 2 clinical trial evaluating Xolair placebo and Xolair (omalizumab) for Chronic Rhinosinusitis and Nasal Polyps. Completed, enrolled 27 participants across 1 site.

Detailed Summary

The investigators are doing this research study to learn more about a drug called Xolair (omalizumab). The investigators want to see if it is an effective treatment for chronic rhinosinusitis (CRS). Specifically, the investigators want to see whether Xolair will make nasal polyps smaller and less thick, and relieve symptoms in people with CRS. Polyps are abnormal growths of tissue that can grow in the lining of your sinuses (the inside of your nose). The investigators also want to find out if it is safe to use (whether it causes side effects).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2010
Enrollment StartDec 1, 2009
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 16.4 years ago

Interventions

Xolair placebodrug

two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)

Xolair (omalizumab)drug

two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)