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

DiMango, Emily, M.D.1 site in 1 country18 target enrollmentSeptember 2005

ConditionsAsthma

InterventionsOmalizumab

DrugsOmalizumab

Overview

Phase: Phase 2
Intervention: Omalizumab
Conditions: Asthma
Sponsor: DiMango, Emily, M.D.
Enrollment: 18
Locations: 1
Primary Endpoint: Asthma symptom utility index
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

February 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

DiMango, Emily, M.D.

Responsible Party

Principal Investigator

Emily DiMango

Assistant Professor

DiMango, Emily, M.D.

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

Arms & Interventions

omaluzimab

Intervention: Omalizumab

Outcomes

Primary Outcomes

Asthma symptom utility index

Time Frame: 6 months

Secondary Outcomes

Secondary endpoints will be changes in asthma Quality of Life, asthma exacerbation rate, and lung function over the 12 week treatmet period.(6 months)