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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180011
• Other study ID #: 20041332
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 10, 2005
• Last updated: February 27, 2012
• Start date: September 2005
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: DiMango, Emily, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Omalizumab
injectable medication

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
DiMango, Emily, M.D.	Genentech, Inc., Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma symptom utility index		6 months	No
Secondary	Secondary endpoints will be changes in asthma Quality of Life, asthma exacerbation rate, and lung function over the 12 week treatmet period.		6 months	No