Evaluate the Effect of Omalizumab on Markers of Asthma Impairment in Patients With Persistent Allergic Asthma
NCT ID: NCT00870584
Last Updated: 2011-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
271 participants
INTERVENTIONAL
2009-03-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Omalizumab
The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.
Placebo
Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
Placebo
Placebo was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of placebo for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.
Interventions
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Omalizumab
Omalizumab was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of omalizumab for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.
Placebo
Placebo was supplied as a lyophilized, sterile powder in a single-use, 5 mL vial. The vial was designed to deliver 150 mg (1.2 mL) of placebo for subcutaneous (s.c.) administration after reconstitution with 1.4 mL sterile water for injection. Doses of more than 150 mg were divided among multiple injection sites to limit injections to not more than 150 mg per site.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
12 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Chesapeake Clinical Research
Baltimore, Maryland, United States
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
The Clinical Research Center, LLC
St Louis, Missouri, United States
Montana Medical Research, Inc.
Missoula, Montana, United States
Maimonides Medical Center, Division of Pediatric Pulmonology
Brooklyn, New York, United States
Allergy Asthma Immunology of Rochester Research Center
Rochester, New York, United States
Alan Kaufman, MD
The Bronx, New York, United States
Allergy & Asthma Center of NC, PA
High Point, North Carolina, United States
Wilmington Medical Research
Wilmington, North Carolina, United States
Allergy and Respiratory Center
Canton, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Oklahoma Allergy & Asthma Clinic
Oklahoma City, Oklahoma, United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States
Baker Allergy Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, United States
Asthma Allergy & Pulmonary Associates
Philadelphia, Pennsylvania, United States
AAPRI Clinical Research Institute
Lincoln, Rhode Island, United States
Pediatric Pulmonary Associates of North Texas, PA
Dallas, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
North Texas Institute for Clinical Trials
Fort Worth, Texas, United States
Allergy & Asthma Associates
Houston, Texas, United States
Lynchburg Pulmonary Associates
Lynchburg, Virginia, United States
Virginia Adult and Pediatric Allergy and Asthma PC
Richmond, Virginia, United States
Asthma Inc.
Seattle, Washington, United States
Pulmonary and Research Associates
Spokane, Washington, United States
Countries
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Related Links
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Related Info
Other Identifiers
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CIGE025AUS33
Identifier Type: -
Identifier Source: org_study_id