Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma

Completed · Phase 4 · Has a placebo group

Conditions studied: Persistent Allergic Asthma

In brief

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 National Heart, Lung, and Blood Institute (NHBLI) Guidelines

Key facts

Study ID

NCT00870584

Run by

Novartis Pharmaceuticals

People needed

271

Starts

2009-03-01

Expected to finish

2010-03-01

Last updated by the study team

2011-11-17

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jasper Summit Research, LLC — Jasper, Alabama, United States
• Allergy Asthma and Immunology Center of Alaska — Anchorage, Alaska, United States
• Medical Research of Arizona, A division of Allergy Asthma & Immunology Associates, LTD — Scottsdale, Arizona, United States
• Waren W. Pleskow, MD — Encinitas, California, United States
• William Ebbeling, MD, Inc — Fresno, California, United States
• Pediatric Care Medical Group, Inc — Huntington Beach, California, United States
• California Allergy & Asthma Medical Group — Palmdale, California, United States
• Allergy Associates Medical Group, Inc — San Diego, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Allergy & Asthma Clinical Research, Inc. — Walnut Creek, California, United States
• Innovative Research of West Florida, Inc — Clearwater, Florida, United States
• Palm Spring Research Institute, Inc — Hialeah, Florida, United States
• Integrity Research, LLC — Pensacola, Florida, United States
• Hugh Windom, MD, PA — Sarasota, Florida, United States
• South Miami Clinical Research, LLC — South Miami, Florida, United States
• Georgia Pollens Clinical Research Centers, Inc — Albany, Georgia, United States
• Sneeze, Wheeze and Itch Associates, LLC — Normal, Illinois, United States
• Chest Medicine Clinical Services — Skokie, Illinois, United States
• Clinical Research Center of Indiana — Indianapolis, Indiana, United States
• Kansas City Allergy & Asthma Center — Overland Park, Kansas, United States
• Cotton-O'Neil Clinical Research Center — Topeka, Kansas, United States
• Abraham Research, PLLC — Crescent Springs, Kentucky, United States
• Rx R&D — Metairie, Louisiana, United States
• Acadiana Medicine Clinic — Opelousas, Louisiana, United States
• Paul A Shapero, MD — Bangor, Maine, United States

Full record on ClinicalTrials.gov

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