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

Completed · Phase 2/Phase 3

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00180011

Run by

DiMango, Emily, M.D.

People needed

18

Starts

2005-09-01

Expected to finish

2012-02-01

Last updated by the study team

2012-02-28

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Columbia University — New York, New York, United States

Full record on ClinicalTrials.gov

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