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

NCT ID: NCT00180011

Last Updated: 2012-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2012-02-29

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

omaluzimab

Group Type: EXPERIMENTAL

Omalizumab

Intervention Type: DRUG

injectable medication

Interventions

Omalizumab

injectable medication

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

DiMango, Emily, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Emily DiMango

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily DiMango, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

20041332

Identifier Type: -

Identifier Source: org_study_id