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Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma

NCT00180011 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-02-28

No results posted yet for this study

Summary

This study will be a randomized, placebo controlled, double blind study to measure the safety and efficacy of a new, injectable asthma medication, omalizumab, in a group of minority with moderate to severe asthma who are not adequately controlled with use of inhaled or oral steroids. Primary endpont will be change in asthma symptom utility index. Secondary endpoints will be changes in asthma Quality of life, asthma exacerbation rate, and lung function over the 12 week treatment period.

Conditions

Interventions

DRUG

Omalizumab

injectable medication

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • DiMango, Emily, M.D.

    lead INDIV

Principal Investigators

  • Emily DiMango, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

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 NCT00180011 on ClinicalTrials.gov