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

DiMango, Emily, M.D.

Status and phase

Completed

Phase 3

Phase 2

Conditions

Asthma

Treatments

Drug: Omalizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00180011

20041332

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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