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Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma

NCT00264849 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2018-06-29

Study results available
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Summary

Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma.

THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.

Conditions

Interventions

DRUG

Omalizumab

Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level.

OTHER

Optimized asthma therapy

Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Tanox

    collaborator INDUSTRY

  • Novartis

    lead INDUSTRY

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Belgium
  • Canada
  • Denmark
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

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 NCT00264849 on ClinicalTrials.gov