Status:
COMPLETED
Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Persistent Allergic Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the effect of omalizumab on markers of impairment in patients with inadequately controlled persistent allergic asthma on Step 4 or above therapy as defined in the 2007 Nationa...
Eligibility Criteria
Inclusion
- Total Asthma Control Test (ACT) score of ≤19 plus at least one of the following in the 4 weeks preceding visit 1, on average:
- Symptoms \> 2 days/week
- Night-time awakenings ≥1 time/week
- Short-acting beta2-agonist (SABA) use for symptom control \>2 days/week forced expiratory volume in 1 second (FEV1) ≤ 80% predicted
Exclusion
- History of intubation for asthma.
- An asthma exacerbation requiring treatment with systemic steroids within 4 weeks of screening (Visit 1).
- Less than 3 months of stable maintenance oral corticosteroid therapy for asthma
- Other protocol-defined inclusion/exclusion criteria applied
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT00870584
Start Date
March 1 2009
End Date
March 1 2010
Last Update
November 17 2011
Active Locations (50)
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1
Jasper Summit Research, LLC
Jasper, Alabama, United States, 35501
2
Allergy Asthma and Immunology Center of Alaska
Anchorage, Alaska, United States, 99508
3
Medical Research of Arizona, A division of Allergy Asthma & Immunology Associates, LTD
Scottsdale, Arizona, United States, 85251
4
Waren W. Pleskow, MD
Encinitas, California, United States, 92024