Back to resultsEfficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omalizumab
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring omalizumab, severe asthma, moderate asthma, injectable asthma medication, Xolair
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
Sites / Locations
- Columbia University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
omaluzimab
Arm Description
Outcomes
Primary Outcome Measures
Asthma symptom utility index
Secondary Outcome Measures
Secondary endpoints will be changes in asthma Quality of Life, asthma exacerbation rate, and lung function over the 12 week treatmet period.
Full Information
NCT ID
NCT00180011
First Posted
September 10, 2005
Last Updated
February 27, 2012
Sponsor
DiMango, Emily, M.D.
Collaborators
Genentech, Inc., Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00180011
Brief Title
Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma
Official Title
Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DiMango, Emily, M.D.
Collaborators
Genentech, Inc., Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
omalizumab, severe asthma, moderate asthma, injectable asthma medication, Xolair
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
omaluzimab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Intervention Description
injectable medication
Primary Outcome Measure Information:
Title
Asthma symptom utility index
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Secondary endpoints will be changes in asthma Quality of Life, asthma exacerbation rate, and lung function over the 12 week treatmet period.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily DiMango, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma
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