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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00180011

Enrollment

Registered

2005-09-16

Start date

2005-09-30

Completion date

2012-02-29

Last updated

2012-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

omalizumab, severe asthma, moderate asthma, injectable asthma medication, Xolair

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.

Interventions

DRUGOmalizumab

injectable medication

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
Asthma symptom utility index	6 months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026