628
Participants
Start Date
April 30, 2004
Primary Completion Date
March 31, 2008
Study Completion Date
March 31, 2008
Omalizumab
The omalizumab dose administered, based on the patient's body weight and total serum IgE level at Screening, and the number of injections and injection volume was determined from the dosing tables in the protocol. Omalizumab 75 to 375 mg was administered subcutaneous (SC) every 2 or 4 weeks depending on the dose.
Placebo
Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol.
Fluticasone
Patients entered the study using their current formulation of any inhaled steroid (proprietary drug and device) ≥ 200 μg/day equivalent of fluticasone administered with a dry-powder inhaler.
Island Medical Research (Allergy and Asthma Center), Rockville Centre
Allergy and Asthma Diagnostic Office, Liverpool
Womes And childrens Hospital of Buffalo, Buffalo
Asthma & Allergy Associates, Ithaca
West Penn Allegheny General Health System, Pittsburgh
501 Howard Av, Altoona
Asthma and Allergy Associates, Upland
Asthma & Allergy Center, Elliott
Virgina Commonwealth, Richmond
Childrens Hospital of the Kings Daughters, Norfolk
Allergy & Asthma Center of North carolina, High Point
Duke University Medical Center, Durham
Family Allergy and Asthma Center, PC, Atlanta
Aeroallergy Research Labs of Savannah, Inc, Savannah
Georgia Pollens, Albany
Miami Children's Hospital, Miami
Alabama Allergy and Asthma Center, Birmingham
Vanderbilt University, Nashville
Allergy Assoc., The ASthma, Allergy & Sinus Ctr, Knoxville
Bernstein Clinical Research Center, Cincinnati
Medical College of Wisconsin, Milwaukee
Rush University Medical Center, Chicago
St. Louis University School of Medicine, St Louis
Midwest Allergy & Asthma Clinic, Omaha
University of Arkansas for Medical Sciences, Little Rock
Clinical Research Center, Little Rock
Resp Dis of Children and Adolescents, Oklahoma City
Pediatric Allergy/Immunology Associates, PA, Dallas
Pediatric Pulmonary Association of North Texas, Dallas
North Texas Institute for Clinical Trials, Fort Worth
Baylor College of Medicine, Houston
7707 Fannin/Ste. 195, Houston
Sylvanna Research, San Antonio
National Jewish Medical and Research Center, Denver
Copperview Medical Center, South Jordan
1304 15th St, Santa Monica
West Coast Clinical Trials, Long Beach
Allergy Associates Medical Group, San Diego
Allergy and Asthma Medical Group & Research Center, San Diego
Integrated Research Group, Riverside
Allergy and Asthma Specialists Medical Group, Huntington Beach
Pediatric Care and Medical Group, Huntington Beach
Southern California Research Center, Mission Viejo
Children's Hosptial of Orange County, Div Asthma, Allergy & Immunology, Orange
CA Allergy & Asthma Med Group, Palmdale
Dr. Joann Blessing-Moore, Palo Alto
Allergy & Asthma Med Group of Diablo Valley CR, Walnut Creek
Allergy and Asthma Associates of Santa Clara Valley RC, San Jose
Bensch Research Associates, Stockton
Clinical Research Institute of Southern Oregon, Medford
A.S.T.H.M.A., Inc., Seattle
508 W 6th Av, Spokane
Northeast Med Research Associates, North Dartmouth
Ocean Allergy & Respiratory Research Center, Brick
UMDNJ, Newark
AAPRI Clinical Research Institute, Lincoln
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY