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

NCT00180011 | Completed Phase 2

• 1 other identifier: 20041332
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Asthma

Keywords

omalizumab; severe asthma; moderate asthma; injectable asthma medication; Xolair

Outcome Measures

Primary Outcomes (1)

• Asthma symptom utility index

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (1)

omaluzimab

EXPERIMENTAL

Drug: Omalizumab

Interventions

Omalizumab DRUG

injectable medication

omaluzimab

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DiMango, Emily, M.D.: lead
• Genentech, Inc.: collaborator
• Novartis: collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Emily DiMango, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2005
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (1)