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Home > "T" Clinical Trials Conditions > The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma
The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma
For Condition: Asthma
Status: Recruiting
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: This study will look at data collected over 1 year to determine the effectiveness of omalizumab (Xolair) in controlling moderate-to-severe allergic asthma in children 6 to 12 years of age whose asthma is persistent and not well controlled. This study will also evaluate the safety of this treatment in terms of side effects and other clinical and laboratory measures.
Details: This study is designed to provide one year efficacy and safety data for subcutaneous (SQ) omalizumab, compared to placebo in children (6 to < 12 years) with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to NHLBI step 3 or 4 (at least medium dose inhaled corticosteroids with or without other controller asthma medications).
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 6 Years/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - outpatient who agrees to written informed consent - male or female of any race aged 6 to 12 years old - body weight greater than or equal to 20 kg (~44 lbs) and less than or equal to 150 kg (~330 lbs) - total serum IgE level equal to or greater than 30 to equal to or less than 1300 IU - diagnosis of allergic asthma equal to or greater than 1 year - positive skin prick test to at least one perennial allergen - equal to or greater than 12% increase in FEV1 within 30 min of taking salbutamol - past medical history of exacerbations - evidence of inadequate asthma symptom control - inhaled corticosteroid dose equivalent to fluticasone DPI equal to or greater than 200 mcg/day AND - 2 exacerbations in the previous 12 months requiring treatment with oral or IV corticosteroids and/or a doubling of the maintenance inhaled corticosteroid dose for at least 3 days OR - 3 exacerbations in the previous 24 months; 1 of which occurred in the previous 12 months (same treatment as above) OR - hospitalization (including ICU) or received ER treatment (including urgent care centers) in the past 12 months for an asthma exacerbation, as defined by the GINA 2002 guidelines for a severe exacerbation Exclusion Criteria: - pregnant or breast-feeding - nonadherence to protocol medicaton washouts - treatment with unacceptable concomitant medications - current or past clinically significant uncontrolled systemic disease - current, past, or potential cancers - platelet levels equal to or less than 130 x 109/L at Visit 1 - previous treatment with Xolair - unable either alone or with their caretaker to perform spirometry, peak flow measurements or completion of the diary card - history of food or drug-related severe anaphylactoid or anaphylactic reaction(s) - history of allergy to antibiotics Other protocol-defined exclusion criteria may apply.
Total Enrollment: 570
Location and Contact Information:
Overall Study Official:
Dr.Gupta, Study Director, Novartis Pharmaceuticals
Allergy and Asthma Medical Group & Research Center *Recruiting*
San Diego, California, 92123
United States
Recruiting Susanne Brown 252-268-2368
Galisano Children's Hospital at Strong Div of Pediatric Pulm & Allergy *Recruiting*
Rochester, New York, 14642
United States
Recruiting Amy Kozlowski 585-275-8580
North Texas Institute for Clinical Trials *Recruiting*
Ft. Worth, Texas, 76132
United States
Recruiting Diane Jones 817-731-9198
Krankenanstalten Gilead *Not yet recruiting*
Bielefeld, , 33617
Germany
Not yet recruiting TARGET Team 0049/ 521 1442730
Dr. Grzegorz Lis *Recruiting*
Kraków, , 30-663
Poland
Recruiting Joanna Wronska (012) 658 20 11
The Nemours Children's Clinic *Recruiting*
Jacksonville, Florida, 32207
United States
Recruiting Betty Deluca 904-390-3483
PoliclÃnico Bancario *Recruiting*
Buenos Aires, Gaona, 1416
Argentina
Recruiting Michelle Trespach 5411 4586 8888
Clinica Soma *Recruiting*
Medellin, ,
Colombia
Recruiting Unknown 00 574 231 4159
Laboratorio Inmunoclinico *Recruiting*
Bogota, ,
Colombia
Recruiting Unknown 571 218 7627
Kinder-und Poliklinik der TU München *Not yet recruiting*
München, , 80804
Germany
Not yet recruiting Simone Henkel 0049/ 89 30683435
Capital Allergy & Respiratory Disease Clinic *Recruiting*
Sacramento, California, 95819
United States
Recruiting Eric Hansen 916-457-8459
Rush University Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Abbi Rees 312-942-6296
Universitätskliniken *Not yet recruiting*
Düsseldorf, , 40225
Germany
Not yet recruiting TARGET Team 0049/ 211 8118066
Hospital de ClÃnicas *Recruiting*
Buenos Aires, Córdoba, 1120
Argentina
Recruiting Michelle Trespach 54 115 950 8585
Health Sciences Centre, Pediatric Allergy & Clinical Immunology, *Recruiting*
Winnepeg, Manitoba, R3A 1R9
Canada
Recruiting Judith Brewer (204) 787-2455
Montreal Children's Hospital *Recruiting*
Montreal, Quebec, H3H 1P3
Canada
Recruiting Susan Ermacoro (514) 412-4400
Asociacion Medica de los Andes *Recruiting*
Bogota, ,
Colombia
Recruiting Unknown Unknown
Klinika Pneumonologii i Alergologii *Recruiting*
Dziadowska, ,
Poland
Recruiting Magdalena Samolej (022) 452 32 04
Wojewódzki Szpital, Specjalistyczny Szpital *Recruiting*
Zgierz, , 95-000
Poland
Recruiting Magdalena Samolej (042) 716 30 02
Pediatric Care and Medical Group *Recruiting*
Huntington Beach, California, 92647
United States
Recruiting Susan Marks 714-842-1441
National Jewish Medical and Research Center *Recruiting*
Denver, Colorado, 80206
United States
Recruiting Amber Pfister 303-398-1852
University of South Florida *Recruiting*
Tampa, Florida, 33613
United States
Recruiting Michelle Grandstaff 813-631-4024
Midwest Allergy & Asthma Clinic *Recruiting*
Omaha, Nebraska, 68114
United States
Recruiting Sherly Leonard 402-397-7400
West Penn Allegheny General Health System *Recruiting*
Pittsburgh, Pennsylvania, 15212
United States
Recruiting Betty Angelini 412-359-6642
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting To Determined 215-590-2549
Hospital de PediatrÃa *Recruiting*
Buenos Aires, Combate de los Pozos, 1245
Argentina
Recruiting Andrea Caruso 54 11 4 824 6685
Pneumologisches Forschungszentrum Hohegeest G.b.R. *Not yet recruiting*
Geesthacht, , 21502
Germany
Not yet recruiting Ingrid Andreson 0049/ 4152 73061
Klinika Pneumatologii i Alergologii *Recruiting*
Ponza, , 60-572
Poland
Recruiting Magdalena Samolej (061) 848 01 11
Children's Hospital Los Angeles Allergy & Immunology *Recruiting*
Los Angeles, California, 90027
United States
Recruiting Theresa Dunaway 323-669-4537
UTHSC-Houston *Recruiting*
Houston, Texas, 77030
United States
Recruiting Evelyn Henninger 713-500-5108
Instituto de Enfermedades *Recruiting*
Rondeau, Mendoza, 5500
Argentina
Recruiting Germán Maravilla 54 0261 429 0628
Dr. Hans-Joachim Seeber *Not yet recruiting*
Großschirma, , 09603
Germany
Not yet recruiting Katrin Grefer 0049/ 37328 244
Johann-Wolfgang-Goethe Universität, Zentrum der Kinderheilkunde *Not yet recruiting*
Frankfurt, , 60590
Germany
Not yet recruiting Simone Henkel 0049/ 69 63011
Southern California Research Center *Recruiting*
Mission Viejo, California, 92691
United States
Recruiting Sherrye West 949-347-8700
Bensch Research Associates *Recruiting*
Stockton, California, 95207
United States
Recruiting Sandy Vallery 209-951-6741
Allergy and Asthma Care *Recruiting*
Ocala, Florida, 34471
United States
Recruiting Darby Seuss 352-629-2223
Dr. Glenn Silber *Recruiting*
Elliott City, Maryland, 21042
United States
Recruiting Carrie Harris 410-730-6000
Children's Respiratory and Critical Care Specialists *Recruiting*
Minneapolis, Minnesota, 55404
United States
Recruiting Christina Huebner 612-863-3226
Pediatric Allergy/Immunology Associates, PA *Recruiting*
Dallas, Texas, 75230
United States
Recruiting Rebecca Martin 972-566-7788
Centro de Alergia e InmunologÃa *Recruiting*
Santa Fe, Yrigoyen Freire, 3000
Argentina
Recruiting Leylén Colemgna 54342 456 0773
Marien-Hospital GmbH *Not yet recruiting*
Wesel, , 46483
Germany
Not yet recruiting TARGET Team 0049/ 281-1040
Groote Schuur Hospital *Recruiting*
Cape Town, , 7925
South Africa
Recruiting Birgit Hohl 27 21 406-6889
218 Hiway Medical Centre *Recruiting*
Durban, Westville, 3630
South Africa
Recruiting Birgit Hohl 27 31 265-1024
Allergy and Asthma Specialists Medical Group *Recruiting*
Huntington Beach, California, 92647
United States
Recruiting Leslie Hamm 714-848-8585
The Nemours Children's Clinic *Recruiting*
Orlando, Florida, 32806
United States
Recruiting Koleen Simpson 407-650-7165
Family Allergy and Asthma Center, PC *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Steve Goodman 404-255-8080
Center for Clinical Research *Recruiting*
Taunton, Massachusetts, 02780
United States
Recruiting Donna Ouillette 508-880-8737
Northeast Med Research Associates *Recruiting*
North Dartmouth, Massachusetts, 02747
United States
Recruiting To Determined 508-992-7695
Allergy & Asthma Center *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Roberta Vierra 401-331-7234
Columbus Childrens, The Ohio State University *Recruiting*
Columbus, Ohio, 43205
United States
Recruiting Melissa Joseph 614-722-4767
Dr. Albert Finn *Recruiting*
Charleston, South Carolina, 29407
United States
Recruiting Elizabeth Lee 843-820-1036
Medical College of Wisconsin *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Mary Klancink 414-266-6165
Respiremos *Recruiting*
Bogota, ,
Colombia
Recruiting Unknown 571 611 4152
Kinderhospital *Not yet recruiting*
Osnabrück, , 49802
Germany
Not yet recruiting TARGET Team 0049/ 541-5602-114
Allergy and Asthma Clinics of Georgia *Recruiting*
Columbus, Georgia, 31904
United States
Recruiting Debra Hale 229-883-8309
Childrens Mercy Hospital and Clinics *Recruiting*
Kansas City, Missouri, 64108
United States
Recruiting Mary Ricklefs 816-234-1605
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Ginny Dudek 919-684-6534
CIDEA *Recruiting*
Buenos Aires, Capital Federal, 1120
Argentina
Recruiting Michelle Trespach 5411 4961 5495
Dr. Brian Lyttle *Recruiting*
London, Ontario, N6A 1V2
Canada
Recruiting Lisa Joy (519) 433-2242
Klinika Pneumonologii i Alergologii *Recruiting*
Rabka Zdrój, , 34-700
Poland
Recruiting Joanna Wronska (018) 267 6060
Island Medical Research (Allergy and Asthma Center) *Recruiting*
Rockville Centre, New York, 11570
United States
Recruiting Beth Erbe 516-536-4863
Hershey Medical Ctr Allergy Clinic & Asthma Research *Recruiting*
Hershey, Pennsylvania, 17033-2360
United States
Recruiting Cathy Mende 717-531-4513
Vanderbilt University *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Lisa Gentry 615-936-5764
Sylvanna Research *Recruiting*
San Antonio, Texas, 78229
United States
Recruiting Shannon Syring 210-614-6673
A.S.T.H.M.A., Inc. *Recruiting*
Seattle, Washington, 98105
United States
Recruiting Laurel Lee 206-525-5520
ClÃnica del Tórax *Recruiting*
Rosario, España, 2000
Argentina
Recruiting Gustavo Vittor 54 341 440 7011
Allergy and Asthma Associates of Santa Clara Valley RC *Recruiting*
San Jose, California, 95117
United States
Recruiting Kathy Thomas 408-553-0709
Allergy & Asthma Med Group of Diablo Valley CR *Recruiting*
Walnut Creek, California, 94598
United States
Recruiting Jennifer Curl 925-935-2599
Miami Children's Hospital *Recruiting*
Miami, Florida, 33155
United States
Recruiting Suyona Yun 305-668-5576
Riley Children's Hospital *Recruiting*
Indianapolis, Indiana, 46203
United States
Recruiting Delana Terrill 317-274-7205
St. Louis University School of Medicine *Recruiting*
St. Louis, Missouri, 63104
United States
Recruiting Geri Sanders 314-268-2700
Hospital Pediátrico del Niño *Recruiting*
Castro Barros, Córdoba, 5000
Argentina
Recruiting Virginia Vazquez 54-351-434-6065
The Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G1X8
Canada
Recruiting Lisa Joy (416) 813-6167
Hôpital Ste-Justine *Not yet recruiting*
Montreal, Quebec, H3T 1C5
Canada
Not yet recruiting Susan Ermacoro (514) 345-2355
Universitätsklinikum Erlangen, Kinderklinik und Poliklinik *Not yet recruiting*
Erlangen, , 91054
Germany
Not yet recruiting Simone Henkel Unknown
Klinika Chorób *Recruiting*
Lublin, , 20-950
Poland
Recruiting Joanna Wronska (081) 718 5477
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72202
United States
Recruiting Karen Althage 501-364-3573
Allergy Associates Medical Group *Recruiting*
San Diego, California, 92120
United States
Recruiting Donna Altmeyer 619-229-2355
Allergy & Clinical Immunology Medical Group *Recruiting*
Santa Monica, California, 90404
United States
Recruiting Lynn Grain 310-828-8534
Mayo Clinic *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Kay Bachman 507-284-5689
St. John's Medical Clinic *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting Dayna Sweeney 417-820-2222
Hospital de Niños Ricardo Gutiérrez *Recruiting*
Buenos Aires, Gallo, 1330
Argentina
Recruiting Andrea Caruso 5411 4962 6280
Clinica Materno Infantil Los Farallones *Recruiting*
Cali, ,
Colombia
Recruiting Unknown 00 572 513 3767
Universitätskinderklinik *Not yet recruiting*
Freiburg, , 79104
Germany
Not yet recruiting Heike Kampmann 0049/ 761-270-4300
Dr. JH Vermeulen *Recruiting*
Cape Town, , 7505
South Africa
Recruiting Birgit Hohl 27 21 930-0630
Timber Lane Allergy & Asthma Research LLC *Recruiting*
Burlington, Vermont, 05403
United States
Recruiting Lynne Moon 802-864-0294
Continental Medical Center Unidad de Neumologia Infantil *Recruiting*
Barranquilla, ,
Colombia
Recruiting Unknown Unknown
Clinic of Pediatrics Specializing in Pneumology and Immunology *Not yet recruiting*
Berlin, , 13353
Germany
Not yet recruiting Ingrid Andresen 0049/ 30-45050
Klinikum Ueckermark *Not yet recruiting*
Schwedt / Oder, , 16303
Germany
Not yet recruiting Katrin Grefer 0049/ 3332 532370
Clinical Research Center of Indiana *Recruiting*
Indianapolis, Indiana, 46208
United States
Recruiting Arthena McBuddy 317-924-8297
Allergy and Asthma Research Institute *Recruiting*
Louisville, Kentucky, 40215
United States
Recruiting Lori Ford 502-368-0732
Universitätsklinikum Mainz *Not yet recruiting*
Mainz, , 55131
Germany
Not yet recruiting TARGET Team 0049/ 6131-172602
Universitätsklinikum der TU *Not yet recruiting*
Dresden, , 01307
Germany
Not yet recruiting Katrin Grefer 0049/ 351 458 3635
St.-Josef-Hospital *Not yet recruiting*
Bochum, , 44791
Germany
Not yet recruiting Heike Kampmann 0049/ 234-509-2611
Additional Information:
Study ID Numbers: CIGE025AIA05;
Study Start Date: March 2004
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079937
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The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma
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