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

Part of paid clinical trials in New York, New York.

Sponsor
DiMango, Emily, M.D.
Study ID
NCT00180011
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Sep 30, 2005
Status verified
Feb 2012
Primary completion
Feb 29, 2012
Completion
Feb 29, 2012

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: omaluzimab

Primary Outcome Measure

Asthma symptom utility index [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia UniversityNew YorkNew York10032-

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