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

This study is currently recruiting participants.

Verified by DiMango, Emily, M.D., September 2005

Sponsors and Collaborators:	DiMango, Emily, M.D. Genentech Novartis
Information provided by:	DiMango, Emily, M.D.
ClinicalTrials.gov Identifier:	NCT00180011

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Omalizumab	Phase II Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Omalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma

Further study details as provided by DiMango, Emily, M.D.:

Primary Outcome Measures:

Primary endpoint will be change in asthma symptom utility index.

Secondary Outcome Measures:

Secondary endpoints will be changes in asthma Quality of Life, asthma exacerbation rate, and lung function over the 12 week treatmet period.

Estimated Enrollment:	40
Study Start Date:	September 2005
Estimated Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180011

Contacts

Contact: Jennifer Sormillon, BSN

(212) 305-0686

jdp27@columbia.edu

Locations

United States, New York
Columbia University	Recruiting
New York, New York, United States, 10032
Contact: Emily DiMango, MD 212-305-0631

Sponsors and Collaborators

DiMango, Emily, M.D.

Genentech

Novartis

Investigators

Principal Investigator:

Emily DiMango, MD

Columbia University

More Information

Study ID Numbers:	20041332, 1060836
Study First Received:	September 10, 2005
Last Updated:	December 9, 2005
ClinicalTrials.gov Identifier:	NCT00180011
Health Authority:	United States: Food and Drug Administration

Keywords provided by DiMango, Emily, M.D.:

omalizumab
severe asthma
moderate asthma
injectable asthma medication
Xolair

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Omalizumab
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses

Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009