Expired Study
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New York, New York 10032


Purpose:

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.


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


Study is Available At:


Original ID:

20041332


NCT ID:

NCT00180011


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

DiMango, Emily, M.D.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Emily DiMango, MD
Principal Investigator
Columbia University

Study Dates

Start Date:September 2005
Completion Date:February 2012
Completion Type:Actual
Primary Completion Date:February 2012
Primary Completion Type:Actual
Verification Date:February 2012
Last Changed Date:February 27, 2012
First Received Date:September 10, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Asthma symptom utility index
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Omalizumab
Description:injectable medication
Arm Name:omaluzimab

Study Arms

Study Arm Type:Experimental
Arm Name:omaluzimab

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:DiMango, Emily, M.D.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Genentech

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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