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

February 27, 2012 updated by: Emily DiMango, DiMango, Emily, M.D.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-30
  • Minority Patients
  • Moderate or Severe allergic asthma (as defined by the National Asthma Education and Prevention Guidelines(7)]. Allergic asthma will be defined as elevated IgE level (> 100 IU/ml) and skin test sensitivity to at least one common aeroallergen
  • asthma control score greater than 1.5 (5) at randomization visit with use of equivalent of at least 1000 mcg fluticasone daily or systemic steroid use
  • FEV1 50-90% predicted at screening and randomization visit

Exclusion Criteria:

  • Active smoking within one year and/or greater than 10-pack year history of smoking
  • Women of childbearing age must be using effective contraception
  • Malignancy diagnosed within the past 5 years
  • Underlying lung disease other than asthma
  • Inability to comply with study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: omaluzimab
Drug: Omalizumab
injectable medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Asthma symptom utility index
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary endpoints will be changes in asthma Quality of Life, asthma exacerbation rate, and lung function over the 12 week treatmet period.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DiMango, Emily, M.D.

Collaborators

Novartis
Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 10, 2005

First Submitted That Met QC Criteria

September 10, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 27, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20041332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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