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Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy

NCT00329381 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2008-06-04

No results posted yet for this study

Summary

In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab(administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

Conditions

Interventions

DRUG

Xolair

Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.

DRUG

Xolair

Xolair 150-375 mg SQ every 2 or 4 weeks based on body weight and pre treatment IgE level.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University of Mississippi Medical Center

    lead OTHER

Principal Investigators

  • Gailen D. Marshall, MD/PhD · University of Mississippi Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-05-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00329381 on ClinicalTrials.gov