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The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma Clinical research trials and The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including 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 Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma clinical trial. Participants typically obtain the most effective healthcare available for their The Efficacy and Safety of Xolair in Children (6 - <12 years) with Moderate-Severe, Inadequately Controlled Allergic Asthma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.

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

Policlínico 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 Clínicas *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 Pediatría *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 Inmunología *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

Clínica 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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