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Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma

NCT01393340 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2011-07-13

No results posted yet for this study

Summary

This pilot study is a double-blinded, randomized controlled, two-centre trial in which subjects will receive 4 to 8 (subcutaneous administered) doses of medication (Omalizumab or placebo) (dose and dosing interval calculated on body weight and baseline total serum IgE). During the treatment period and follow-up, the clinical efficacy of the treatment will be assessed by evaluation of symptoms, Quality of Life questionnaire, morning Peak Expiratory Flow measurement, smell test, nasal endoscopy, CT-scan, peak nasal inspiratory flow and spirometry. Biological activity will be evaluated by measuring peripheral and local (in serum, in nasal secretions, biopsies) markers of inflammation.

Study hypothesis

1. Evaluation of the efficacy and safety of anti-IgE (Omalizumab) in patients with nasal polyposis and comorbid asthma.
2. Exploration of anti-IgE effects on local and systemic metabolism of IgE in nasal polyposis
3. Clinical assessment of the IgE theory in the pathogenesis of nasal polyps

Conditions

Interventions

DRUG

Omalizumab

Omalizumab (Xolair(R)) is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human IgE. Molecular weight is approximately 149 kilodaltons. Xolair(R) is a sterile, white, preservative-free, lyophilized powder contained in a single-use vial, reconstituted with Sterile Water For Injection (SWFI), and administered as subcutaneous (SC) injection. Xolair(R) will be administered subcutaneously in a dose of 75 to 375mg every 2 to 4 weeks. Doses (mg) and dosing frequency are determined by total serum IgE level (IU/ml) measured at the start of treatment and body weight (kg). During this 20-week during trial patients will receive 4 or 8 doses of omalizumab.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Novartis Pharma AG, Switzerland

    collaborator UNKNOWN

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Paul Van Cauwenberge, PhD, MD · University Hospital, Ghent, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-10-31
Completion
2009-12-31

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01393340 on ClinicalTrials.gov